CClinicalTrials.gg
Status unknownNCT05265858HIPPROCLIPSUpdated Mar 4, 2022

Clinical Phenotypes in Persons With Hip Osteoarthritis and Prognostic Factors for Outcome After Total Hip Arthroplasty

An observational study in Hip Osteoarthritis and Total Hip Arthroplasty, sponsored by Hasselt University. Status unknown at 2 sites in Belgium. Per ClinicalTrials.gov, last updated 2022-03-04.

Sponsored by Hasselt University · Observational

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Sex
All
01

Study summary

This prospective longitudinal cohort study aims (1) to identify clinical phenotypes in persons with hip osteoarthritis and after total hip arthroplasty, and (2) to identify prognostic factors for outcomes after total hip arthroplasty.

Read the detailed description

Osteoarthritis (OA) is one of the leading causes of pain and disability worldwide, with more than 300 million people currently affected by the disease. The hip joint is clinically one of the most affected locations of OA. Each year, more than 40 million prevalent cases and more than 2 million incident cases of hip OA are reported worldwide. The global prevalence and incidence of hip OA are expected to increase considerably in the upcoming decades, as a result of the aging population and an increasing prevalence of risk factors such as obesity and sedentary lifestyle. Since the population with hip OA is highly heterogeneous, individualized care pathways are needed instead of the current one-size-fits-all approach in clinical management. The identification of distinct subgroups within the population with hip OA might offer a foundation for individualized care pathways with the potential improvement of clinical outcomes. Therefore, the first aim of this longitudinal prospective cohort study is to identify clinical phenotypes in persons with hip osteoarthritis based on a set of contributing biopsychosocial variables, and to compare these phenotypes in terms of pain and disability before and after total hip arthroplasty (THA).

Correspondingly with the increasing prevalence and incidence of hip OA, the mean utilization rate of hip implants per 100.000 inhabitants in Organisation for Economic Co-operation and Development (OECD) countries is expected to increase from 145 in 2010 to 275 in 2050. Annually, more than 30.000 THA's are performed in Belgium. This number is growing considerably, especially in younger, working-age patients. Total hip arthroplasty (THA) is a cost-effective procedure in patients with end-stage hip OA. However, previous studies have reported that 8% of patients are dissatisfied with the outcome, and up to 23% of patients report long-term pain after THA. Furthermore, over 30% of patients report activity limitations and about 25% of patients report participation restrictions after THA. An important step towards understanding and improving outcomes after THA is prognostic factor research. Therefore, the second aim of this clinical study is to identify prognostic factors for outcomes of pain and disability after THA in persons with hip OA.

In this prospective longitudinal cohort study, 200 persons undergoing total hip arthroplasty for hip OA will be followed one-year post-surgery. Participants are recruited at the orthopaedic department of 'Ziekenhuis Oost-Limburg' in Genk and at 'de heuppraktijk' in Herselt. Participants will be assessed on a set of biopsychosocial variables, including pain-related fear-avoidance behavior, perceived injustice, psychopathology, traumatic experiences, social support, and self-efficacy. Furthermore, the somatosensory function will be assessed with thermal quantitative sensory testing (QST) and muscle strength will be assessed with a handheld dynamometer (MicroFet 2). Outcome measures include the Hip Disability and Osteoarthritis Outcome Score (HOOS), the OARSI recommended minimum core set of performance-based outcome measures (PBMs), the Patient-Specific Functional Scale (PSFS), Pain intensity (NPRS), Global Perceived Effect (GPE), and satisfaction (NRS). All these measurements will be performed before surgery, as well as 6 weeks, 3 months, and 12 months after surgery. Pain-related fear-avoidance behavior, perceived injustice, anxiety, depression, and pain will be assessed in the early postoperative phase.

02

Conditions studied

  • Hip Osteoarthritis
  • Total Hip Arthroplasty

Keywords

  • Hip Osteoarthritis
  • Total Hip Arthroplasty
  • Prognostic factors
  • Pain
  • Disability
  • Psychotraumatic events
  • Fear-Avoidance
  • Self-efficacy
  • Perceived Injustice
  • Quantitative Sensory Testing
  • Clinical phenotype
  • Psychopathology
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 200 is above the median of 100 across 791 observational studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Hasselt University is the lead sponsor of 195 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Persons with hip osteoarthritis who will undergo THA

Inclusion criteria

  • Persons with a confirmed clinical or radiographic primary diagnosis of hip osteoarthritis who will undergo total hip arthroplasty (THA)

Exclusion criteria

Exclusion Criteria:

  • Rheumatoid arthritis or other rheumatic diseases
  • Another pathological condition explaining the symptoms (e.g. avascular necrosis)
  • Neurological condition (e.g. Parkinson's disease, stroke...) significantly influencing the symptoms of hip osteoarthritis.
  • Revision THA
  • History of pathological fractures (e.g. osteoporosis, tumor...)
  • Contralateral THA during follow-up period
  • Total knee arthroplasty (TKA) during follow-up period
  • Another surgery planned during follow-up period
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with hip osteoarthritis

    Patients with hip osteoarthritis who will undergo total hip arthroplasty

    Procedure: Total Hip Arthroplasty

Interventions

  • ProcedureTotal Hip Arthroplasty

    Direct Anterior Approach (DAA) Total Hip Arthroplasty (THA)

06

What researchers measure

Primary outcomes

  1. Hip disability and Osteoarthritis Outcome Score (HOOS)

    The HOOS is a self-reported questionnaire for evaluating symptoms and disability in patients with hip complaints. The questionnaire has been validated in Dutch and consists of 40 items, divided into five subscales: symptoms (5 items), pain (10 items), functioning in activities of daily living (ADL)(17 items), functioning in sport and recreation (4 items), and quality of life (4 items). Each question is scored on a 5-point Likert scale, in which a higher score reflects fewer complaints. A normalized score from 0 to 100 is calculated for the total scale, and for each subscale individually.

    Time frame: 1 week before THA

  2. Hip disability and Osteoarthritis Outcome Score (HOOS)

    The HOOS is a self-reported questionnaire for evaluating symptoms and disability in patients with hip complaints. The questionnaire has been validated in Dutch and consists of 40 items, divided into five subscales: symptoms (5 items), pain (10 items), functioning in activities of daily living (ADL)(17 items), functioning in sport and recreation (4 items), and quality of life (4 items). Each question is scored on a 5-point Likert scale, in which a higher score reflects fewer complaints. A normalized score from 0 to 100 is calculated for the total scale, and for each subscale individually.

    Time frame: 6 weeks after THA

  3. Hip disability and Osteoarthritis Outcome Score (HOOS)

    The HOOS is a self-reported questionnaire for evaluating symptoms and disability in patients with hip complaints. The questionnaire has been validated in Dutch and consists of 40 items, divided into five subscales: symptoms (5 items), pain (10 items), functioning in activities of daily living (ADL)(17 items), functioning in sport and recreation (4 items), and quality of life (4 items). Each question is scored on a 5-point Likert scale, in which a higher score reflects fewer complaints. A normalized score from 0 to 100 is calculated for the total scale, and for each subscale individually.

    Time frame: 3 months after THA

  4. Hip disability and Osteoarthritis Outcome Score (HOOS)

    The HOOS is a self-reported questionnaire for evaluating symptoms and disability in patients with hip complaints. The questionnaire has been validated in Dutch and consists of 40 items, divided into five subscales: symptoms (5 items), pain (10 items), functioning in activities of daily living (ADL)(17 items), functioning in sport and recreation (4 items), and quality of life (4 items). Each question is scored on a 5-point Likert scale, in which a higher score reflects fewer complaints. A normalized score from 0 to 100 is calculated for the total scale, and for each subscale individually.

    Time frame: 12 months after THA

Secondary outcomes

  1. Patient Specific Functional Scale (PSFS)

    The PSFS measures the functional status of the patient. The patient is asked to name the three most important activities for him that are difficult for him or which he is unable to perform because of his problems. Finally, the patient scores the degree of impairment in the activities on an 11-point NRS scale (0-10), where 0 stands for 'cannot perform the activity' and 10 'can perform the activity just as well as before occurrence of the problem'.

    Time frame: 1 week before THA

  2. Patient Specific Functional Scale (PSFS)

    The PSFS measures the functional status of the patient. The patient is asked to name the three most important activities for him that are difficult for him or which he is unable to perform because of his problems. Finally, the patient scores the degree of impairment in the activities on an 11-point NRS scale (0-10), where 0 stands for 'cannot perform the activity' and 10 'can perform the activity just as well as before occurrence of the problem'.

    Time frame: 6 weeks after THA

  3. Patient Specific Functional Scale (PSFS)

    The PSFS measures the functional status of the patient. The patient is asked to name the three most important activities for him that are difficult for him or which he is unable to perform because of his problems. Finally, the patient scores the degree of impairment in the activities on an 11-point NRS scale (0-10), where 0 stands for 'cannot perform the activity' and 10 'can perform the activity just as well as before occurrence of the problem'.

    Time frame: 3 months after THA

  4. Patient Specific Functional Scale (PSFS)

    The PSFS measures the functional status of the patient. The patient is asked to name the three most important activities for him that are difficult for him or which he is unable to perform because of his problems. Finally, the patient scores the degree of impairment in the activities on an 11-point NRS scale (0-10), where 0 stands for 'cannot perform the activity' and 10 'can perform the activity just as well as before occurrence of the problem'.

    Time frame: 12 months after THA

  5. 36-Item Short Form Health Survey (SF-36)

    The SF-36 is used to measure perceived health and health-related quality of life. The questionnaire has 36 items containing eight health-related categories: physical functioning, role limitations due to physical problems, role limitations due to emotional problems, pain, mental health, energy, general health perception, and social functioning. A high score corresponds to a better state of health.

    Time frame: 1 week before THA

  6. 36-Item Short Form Health Survey (SF-36)

    The SF-36 is used to measure perceived health and health-related quality of life. The questionnaire has 36 items containing eight health-related categories: physical functioning, role limitations due to physical problems, role limitations due to emotional problems, pain, mental health, energy, general health perception, and social functioning. A high score corresponds to a better state of health.

    Time frame: 6 weeks after THA

  7. 36-Item Short Form Health Survey (SF-36)

    The SF-36 is used to measure perceived health and health-related quality of life. The questionnaire has 36 items containing eight health-related categories: physical functioning, role limitations due to physical problems, role limitations due to emotional problems, pain, mental health, energy, general health perception, and social functioning. A high score corresponds to a better state of health.

    Time frame: 3 months after THA

  8. 36-Item Short Form Health Survey (SF-36)

    The SF-36 is used to measure perceived health and health-related quality of life. The questionnaire has 36 items containing eight health-related categories: physical functioning, role limitations due to physical problems, role limitations due to emotional problems, pain, mental health, energy, general health perception, and social functioning. A high score corresponds to a better state of health.

    Time frame: 12 months after THA

  9. Global Perceived Effect (GPE)

    The patient's opinion about recovery after THA will be measured using the Global Perceived Effect (GPE) score on a 7-point Likert scale, where 1 stands for "a lot worse" and 7 for "a lot better".

    Time frame: 1 day after THA

  10. Global Perceived Effect (GPE)

    The patient's opinion about recovery after THA will be measured using the Global Perceived Effect (GPE) score on a 7-point Likert scale, where 1 stands for "a lot worse" and 7 for "a lot better".

    Time frame: 3 days after THA

  11. Global Perceived Effect (GPE)

    The patient's opinion about recovery after THA will be measured using the Global Perceived Effect (GPE) score on a 7-point Likert scale, where 1 stands for "a lot worse" and 7 for "a lot better".

    Time frame: 5 days after THA

  12. Global Perceived Effect (GPE)

    The patient's opinion about recovery after THA will be measured using the Global Perceived Effect (GPE) score on a 7-point Likert scale, where 1 stands for "a lot worse" and 7 for "a lot better".

    Time frame: 7 days after THA

  13. Global Perceived Effect (GPE)

    The patient's opinion about recovery after THA will be measured using the Global Perceived Effect (GPE) score on a 7-point Likert scale, where 1 stands for "a lot worse" and 7 for "a lot better".

    Time frame: 6 weeks after THA

  14. Global Perceived Effect (GPE)

    The patient's opinion about recovery after THA will be measured using the Global Perceived Effect (GPE) score on a 7-point Likert scale, where 1 stands for "a lot worse" and 7 for "a lot better".

    Time frame: 3 months after THA

  15. Global Perceived Effect (GPE)

    The patient's opinion about recovery after THA will be measured using the Global Perceived Effect (GPE) score on a 7-point Likert scale, where 1 stands for "a lot worse" and 7 for "a lot better".

    Time frame: 12 months after THA

  16. Numerical Rating Scale (NRS) of Patient Satisfaction

    Patient satisfaction will be measured on an 11-point Numerical Rating Scale (NRS), where 0 stands for "no pain" and 10 for "worst imaginable pain".

    Time frame: 1 day after THA

  17. Numerical Rating Scale (NRS) of Patient Satisfaction

    Patient satisfaction will be measured on an 11-point Numerical Rating Scale (NRS), where 0 stands for "no pain" and 10 for "worst imaginable pain".

    Time frame: 3 days after THA

  18. Numerical Rating Scale (NRS) of Patient Satisfaction

    Patient satisfaction will be measured on an 11-point Numerical Rating Scale (NRS), where 0 stands for "no pain" and 10 for "worst imaginable pain".

    Time frame: 5 days after THA

  19. Numerical Rating Scale (NRS) of Patient Satisfaction

    Patient satisfaction will be measured on an 11-point Numerical Rating Scale (NRS), where 0 stands for "no pain" and 10 for "worst imaginable pain".

    Time frame: 7 days after THA

  20. Numerical Rating Scale (NRS) of Patient Satisfaction

    Patient satisfaction will be measured on an 11-point Numerical Rating Scale (NRS), where 0 stands for "no pain" and 10 for "worst imaginable pain".

    Time frame: 6 weeks after THA

  21. Numerical Rating Scale (NRS) of Patient Satisfaction

    Patient satisfaction will be measured on an 11-point Numerical Rating Scale (NRS), where 0 stands for "no pain" and 10 for "worst imaginable pain".

    Time frame: 3 months after THA

  22. Numerical Rating Scale (NRS) of Patient Satisfaction

    Patient satisfaction will be measured on an 11-point Numerical Rating Scale (NRS), where 0 stands for "no pain" and 10 for "worst imaginable pain".

    Time frame: 12 months after THA

  23. Numerical Pain Rating Scale (NPRS)

    Average pain intensity last week and pain intensity at the moment will be measured on an 11-point Numerical Pain Rating Scale (NPRS), where 0 stands for "no pain" and 10 for "worst imaginable pain".

    Time frame: 1 week before THA

  24. Numerical Pain Rating Scale (NPRS)

    Average pain intensity last week and pain intensity at the moment will be measured on an 11-point Numerical Pain Rating Scale (NPRS), where 0 stands for "no pain" and 10 for "worst imaginable pain".

    Time frame: 1 day after THA

  25. Numerical Pain Rating Scale (NPRS)

    Average pain intensity last week and pain intensity at the moment will be measured on an 11-point Numerical Pain Rating Scale (NPRS), where 0 stands for "no pain" and 10 for "worst imaginable pain".

    Time frame: 3 days after THA

  26. Numerical Pain Rating Scale (NPRS)

    Average pain intensity last week and pain intensity at the moment will be measured on an 11-point Numerical Pain Rating Scale (NPRS), where 0 stands for "no pain" and 10 for "worst imaginable pain".

    Time frame: 5 days after THA

  27. Numerical Pain Rating Scale (NPRS)

    Average pain intensity last week and pain intensity at the moment will be measured on an 11-point Numerical Pain Rating Scale (NPRS), where 0 stands for "no pain" and 10 for "worst imaginable pain".

    Time frame: 7 days after THA

  28. Numerical Pain Rating Scale (NPRS)

    Average pain intensity last week and pain intensity at the moment will be measured on an 11-point Numerical Pain Rating Scale (NPRS), where 0 stands for "no pain" and 10 for "worst imaginable pain".

    Time frame: 6 weeks after THA

  29. Numerical Pain Rating Scale (NPRS)

    Average pain intensity last week and pain intensity at the moment will be measured on an 11-point Numerical Pain Rating Scale (NPRS), where 0 stands for "no pain" and 10 for "worst imaginable pain".

    Time frame: 3 months after THA

  30. Numerical Pain Rating Scale (NPRS)

    Average pain intensity last week and pain intensity at the moment will be measured on an 11-point Numerical Pain Rating Scale (NPRS), where 0 stands for "no pain" and 10 for "worst imaginable pain".

    Time frame: 12 months after THA

  31. 30-second Chair Stand Test

    The 30-second Chair Stand Test will be used to assess sit-to-stand activity (physical function). The maximum number of chair stand repetitions within 30 seconds will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU).

    Time frame: 1 week before THA

  32. 30-second Chair Stand Test

    The 30-second Chair Stand Test will be used to assess sit-to-stand activity (physical function). The maximum number of chair stand repetitions within 30 seconds will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU).

    Time frame: 6 weeks after THA

  33. 30-second Chair Stand Test

    The 30-second Chair Stand Test will be used to assess sit-to-stand activity (physical function). The maximum number of chair stand repetitions within 30 seconds will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU).

    Time frame: 3 months after THA

  34. 30-second Chair Stand Test

    The 30-second Chair Stand Test will be used to assess sit-to-stand activity (physical function). The maximum number of chair stand repetitions within 30 seconds will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU).

    Time frame: 12 months after THA

  35. 11-step Stair Climb Test

    The 11-step Stair Climb Test will be used to assess ascending and descending stair activity (physical function). The time in seconds to ascend and descend 11 stairs will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU).

    Time frame: 1 week before THA

  36. 11-step Stair Climb Test

    The 11-step Stair Climb Test will be used to assess ascending and descending stair activity (physical function). The time in seconds to ascend and descend 11 stairs will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU).

    Time frame: 6 weeks after THA

  37. 11-step Stair Climb Test

    The 11-step Stair Climb Test will be used to assess ascending and descending stair activity (physical function). The time in seconds to ascend and descend 11 stairs will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU).

    Time frame: 3 months after THA

  38. 11-step Stair Climb Test

    The 11-step Stair Climb Test will be used to assess ascending and descending stair activity (physical function). The time in seconds to ascend and descend 11 stairs will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU).

    Time frame: 12 months after THA

  39. 40-meter (4x10-meter) Fast Paced Walk Test

    The 40-meter (4x10-meter) Fast Paced Walk Test will be used to assess short distance walking activity (physical function). The time in seconds to walk 4 x 10 meters for a total of 40 meters will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU).

    Time frame: 1 week before THA

  40. 40-meter (4x10-meter) Fast Paced Walk Test

    The 40-meter (4x10-meter) Fast Paced Walk Test will be used to assess short distance walking activity (physical function). The time in seconds to walk 4 x 10 meters for a total of 40 meters will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU).

    Time frame: 6 weeks after THA

  41. 40-meter (4x10-meter) Fast Paced Walk Test

    The 40-meter (4x10-meter) Fast Paced Walk Test will be used to assess short distance walking activity (physical function). The time in seconds to walk 4 x 10 meters for a total of 40 meters will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU).

    Time frame: 3 months after THA

  42. 40-meter (4x10-meter) Fast Paced Walk Test

    The 40-meter (4x10-meter) Fast Paced Walk Test will be used to assess short distance walking activity (physical function). The time in seconds to walk 4 x 10 meters for a total of 40 meters will be used as the outcome value. Movement quality during the performance-based tests is assessed based on acceleration data measured with an Inertial Measurement Unit (IMU).

    Time frame: 12 months after THA

Other outcomes

  1. Thermal Detection and Pain Threshold Temperatures

    Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. The Medoc Advanced Thermosensory Stimulator (TSA) - 2 system will be used to perform a standardized test protocol. Detection and pain threshold temperatures (in °C) will be assessed locally (at the most painful site of the hip) and remotely (at the contralateral wrist) using the TSA limits protocol: * Cold Detection Threshold (CDT) * Warmth Detection Threshold (WDT) * Cold Pain Threshold (CPT) * Heat Pain Threshold (HPT)

    Time frame: 1 week before THA

  2. Thermal Detection and Pain Threshold Temperatures

    Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. The Medoc Advanced Thermosensory Stimulator (TSA) - 2 system will be used to perform a standardized test protocol. Detection and pain threshold temperatures (in °C) will be assessed locally (at the most painful site of the hip) and remotely (at the contralateral wrist) using the TSA limits protocol: * Cold Detection Threshold (CDT) * Warmth Detection Threshold (WDT) * Cold Pain Threshold (CPT) * Heat Pain Threshold (HPT)

    Time frame: 6 weeks after THA

  3. Thermal Detection and Pain Threshold Temperatures

    Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. The Medoc Advanced Thermosensory Stimulator (TSA) - 2 system will be used to perform a standardized test protocol. Detection and pain threshold temperatures (in °C) will be assessed locally (at the most painful site of the hip) and remotely (at the contralateral wrist) using the TSA limits protocol: * Cold Detection Threshold (CDT) * Warmth Detection Threshold (WDT) * Cold Pain Threshold (CPT) * Heat Pain Threshold (HPT)

    Time frame: 3 months after THA

  4. Thermal Detection and Pain Threshold Temperatures

    Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. The Medoc Advanced Thermosensory Stimulator (TSA) - 2 system will be used to perform a standardized test protocol. Detection and pain threshold temperatures (in °C) will be assessed locally (at the most painful site of the hip) and remotely (at the contralateral wrist) using the TSA limits protocol: * Cold Detection Threshold (CDT) * Warmth Detection Threshold (WDT) * Cold Pain Threshold (CPT) * Heat Pain Threshold (HPT)

    Time frame: 12 months after THA

  5. Temporal Summation of Pain (TSP)

    Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. The Medoc TSA-2 system will be used to perform a standardized test protocol. Temporal summation of pain (TSP) will be assessed at the contralateral wrist using a 2-minute tonic heat stimulus and patient-controlled temperature. Participants are presented with a tonic heat stimulus and are instructed to maintain their initial sensation for two minutes via the remote controller. To quantify temporal adaptation and temporal summation of pain, the slope and magnitude of temperature changes will be extracted and the areas under the curve will be calculated.

    Time frame: 1 week before THA

  6. Temporal Summation of Pain (TSP)

    Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. The Medoc TSA-2 system will be used to perform a standardized test protocol. Temporal summation of pain (TSP) will be assessed at the contralateral wrist using a 2-minute tonic heat stimulus and patient-controlled temperature. Participants are presented with a tonic heat stimulus and are instructed to maintain their initial sensation for two minutes via the remote controller. To quantify temporal adaptation and temporal summation of pain, the slope and magnitude of temperature changes will be extracted and the areas under the curve will be calculated.

    Time frame: 6 weeks after THA

  7. Temporal Summation of Pain (TSP)

    Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. The Medoc TSA-2 system will be used to perform a standardized test protocol. Temporal summation of pain (TSP) will be assessed at the contralateral wrist using a 2-minute tonic heat stimulus and patient-controlled temperature. Participants are presented with a tonic heat stimulus and are instructed to maintain their initial sensation for two minutes via the remote controller. To quantify temporal adaptation and temporal summation of pain, the slope and magnitude of temperature changes will be extracted and the areas under the curve will be calculated.

    Time frame: 3 months after THA

  8. Temporal Summation of Pain (TSP)

    Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. QST is a non-invasive examination of the somatosensory system commonly used in pain diagnosis. The Medoc TSA-2 system will be used to perform a standardized test protocol. Temporal summation of pain (TSP) will be assessed at the contralateral wrist using a 2-minute tonic heat stimulus and patient-controlled temperature. Participants are presented with a tonic heat stimulus and are instructed to maintain their initial sensation for two minutes via the remote controller. To quantify temporal adaptation and temporal summation of pain, the slope and magnitude of temperature changes will be extracted and the areas under the curve will be calculated.

    Time frame: 12 months after THA

  9. Conditioned Pain Modulation (CPM)

    Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. The Medoc TSA-2 system will be used to perform a standardized test protocol. Conditioned pain modulation will be evaluated using a Dual-Thermode program with two different stimuli: * Test stimulus: this heat stimulus will be administered twice at the contralateral wrist. Once on its own before administering the conditioning stimulus, and once during the conditioning heat stimulus at the ipsilateral wrist. * Conditioning stimulus: this heat stimulus will be administered at the ipsilateral wrist after first applying the test stimulus. The difference in pain intensity at the contralateral wrist during the stand-alone test stimulus and the test stimulus during the conditioning stimulus will be calculated. Pain intensity is assessed using a Numerical Pain Rating Scale (NPRS) ranging from 0 to 100, where 0 stands for "no pain", and 100 for "worst imaginable pain".

    Time frame: 1 week before THA

  10. Conditioned Pain Modulation (CPM)

    Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. The Medoc TSA-2 system will be used to perform a standardized test protocol. Conditioned pain modulation will be evaluated using a Dual-Thermode program with two different stimuli: * Test stimulus: this heat stimulus will be administered twice at the contralateral wrist. Once on its own before administering the conditioning stimulus, and once during the conditioning heat stimulus at the ipsilateral wrist. * Conditioning stimulus: this heat stimulus will be administered at the ipsilateral wrist after first applying the test stimulus. The difference in pain intensity at the contralateral wrist during the stand-alone test stimulus and the test stimulus during the conditioning stimulus will be calculated. Pain intensity is assessed using a Numerical Pain Rating Scale (NPRS) ranging from 0 to 100, where 0 stands for "no pain", and 100 for "worst imaginable pain".

    Time frame: 6 weeks after THA

  11. Conditioned Pain Modulation (CPM)

    Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. The Medoc TSA-2 system will be used to perform a standardized test protocol. Conditioned pain modulation will be evaluated using a Dual-Thermode program with two different stimuli: * Test stimulus: this heat stimulus will be administered twice at the contralateral wrist. Once on its own before administering the conditioning stimulus, and once during the conditioning heat stimulus at the ipsilateral wrist. * Conditioning stimulus: this heat stimulus will be administered at the ipsilateral wrist after first applying the test stimulus. The difference in pain intensity at the contralateral wrist during the stand-alone test stimulus and the test stimulus during the conditioning stimulus will be calculated. Pain intensity is assessed using a Numerical Pain Rating Scale (NPRS) ranging from 0 to 100, where 0 stands for "no pain", and 100 for "worst imaginable pain".

    Time frame: 3 months after THA

  12. Conditioned Pain Modulation (CPM)

    Thermal Quantitative sensory testing (QST) will be used to investigate nociceptive stimulus processing. The Medoc TSA-2 system will be used to perform a standardized test protocol. Conditioned pain modulation will be evaluated using a Dual-Thermode program with two different stimuli: * Test stimulus: this heat stimulus will be administered twice at the contralateral wrist. Once on its own before administering the conditioning stimulus, and once during the conditioning heat stimulus at the ipsilateral wrist. * Conditioning stimulus: this heat stimulus will be administered at the ipsilateral wrist after first applying the test stimulus. The difference in pain intensity at the contralateral wrist during the stand-alone test stimulus and the test stimulus during the conditioning stimulus will be calculated. Pain intensity is assessed using a Numerical Pain Rating Scale (NPRS) ranging from 0 to 100, where 0 stands for "no pain", and 100 for "worst imaginable pain".

    Time frame: 12 months after THA

  13. Mini International Neuropsychiatric Interview - Simplified (M.I.N.I.-S for DSM-V)

    The MINI-S is a brief structured diagnostic interview for the major psychiatric disorders in the DSM-5. The MINI-S assesses the 17 most common disorders in mental health, including Bipolar Disorder Type 1 and Type 2, Major Depressive Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Generalized Anxiety Disorder, Obsessive Compulsive Disorder, Post-Traumatic Stress Disorder, Acute Stress Disorder, Attention-Deficit/Hyperactivity Disorder, Anorexia Nervosa, Bulimia Nervosa, Alcohol Use Disorder, Substance other than alcohol Use Disorder, Psychotic Disorders.

    Time frame: 1 week before THA

  14. Mini International Neuropsychiatric Interview - Simplified (M.I.N.I.-S for DSM-V)

    The MINI-S is a brief structured diagnostic interview for the major psychiatric disorders in the DSM-5. The MINI-S assesses the 17 most common disorders in mental health, including Bipolar Disorder Type 1 and Type 2, Major Depressive Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, Generalized Anxiety Disorder, Obsessive Compulsive Disorder, Post-Traumatic Stress Disorder, Acute Stress Disorder, Attention-Deficit/Hyperactivity Disorder, Anorexia Nervosa, Bulimia Nervosa, Alcohol Use Disorder, Substance other than alcohol Use Disorder, Psychotic Disorders.

    Time frame: 12 months after THA

  15. Traumatic Experiences Checklist (TEC)

    The Traumatic Experiences Checklist (TEC) is a self-reported questionnaire that investigates traumatic experiences in the past. The TEC consists of 31 items, which represent traumatic experiences. Participants should indicate whether they experienced the events and at what age it occurred. The extent to which the event was stressful for the person is also examined. This is scored on a 5-point scale ranging from 'to some extent' to 'to a very severe degree'.

    Time frame: 1 week before THA

  16. Traumatic Experiences Checklist (TEC)

    The Traumatic Experiences Checklist (TEC) is a self-reported questionnaire that investigates traumatic experiences in the past. The TEC consists of 31 items, which represent traumatic experiences. Participants should indicate whether they experienced the events and at what age it occurred. The extent to which the event was stressful for the person is also examined. This is scored on a 5-point scale ranging from 'to some extent' to 'to a very severe degree'.

    Time frame: 12 months after THA

  17. Childhood Trauma Questionnaire (CTQ)

    The CTQ is used to determine whether a person has experienced childhood trauma. The CTQ is a 25-item retrospective self-reported questionnaire that evaluates childhood events. Each question is answered on a 5-point Likert scale (1 never true, 2 often true, 3 sometimes, 4 often true, 5 true). The questionnaire assesses five dimensions of child abuse: (1) Physical abuse, (2) Emotional abuse, (3) Sexual abuse, (4) Physical neglect and (5) Emotional neglect.

    Time frame: 1 week before THA

  18. Childhood Trauma Questionnaire (CTQ)

    The CTQ is used to determine whether a person has experienced childhood trauma. The CTQ is a 25-item retrospective self-reported questionnaire that evaluates childhood events. Each question is answered on a 5-point Likert scale (1 never true, 2 often true, 3 sometimes, 4 often true, 5 true). The questionnaire assesses five dimensions of child abuse: (1) Physical abuse, (2) Emotional abuse, (3) Sexual abuse, (4) Physical neglect and (5) Emotional neglect.

    Time frame: 12 months after THA

  19. Hospital Anxiety and Depression Scale (HADS)

    The HADS is a 14-item questionnaire evaluating anxiety and depression complaints without involving physical complaints. The HADS consists of two subscales, one subscale covers symptoms of anxiety (HADS-A), the other symptoms of depression (HADS-D). Each item is scored from zero ("not applicable") to three ("certainly applicable"). The maximum score on each subscale is 21, with higher values indicating more anxiety/depression symptoms.

    Time frame: 1 week before THA

  20. Hospital Anxiety and Depression Scale (HADS)

    The HADS is a 14-item questionnaire evaluating anxiety and depression complaints without involving physical complaints. The HADS consists of two subscales, one subscale covers symptoms of anxiety (HADS-A), the other symptoms of depression (HADS-D). Each item is scored from zero ("not applicable") to three ("certainly applicable"). The maximum score on each subscale is 21, with higher values indicating more anxiety/depression symptoms.

    Time frame: 1 week after THA

  21. Hospital Anxiety and Depression Scale (HADS)

    The HADS is a 14-item questionnaire evaluating anxiety and depression complaints without involving physical complaints. The HADS consists of two subscales, one subscale covers symptoms of anxiety (HADS-A), the other symptoms of depression (HADS-D). Each item is scored from zero ("not applicable") to three ("certainly applicable"). The maximum score on each subscale is 21, with higher values indicating more anxiety/depression symptoms.

    Time frame: 6 weeks after THA

  22. Hospital Anxiety and Depression Scale (HADS)

    The HADS is a 14-item questionnaire evaluating anxiety and depression complaints without involving physical complaints. The HADS consists of two subscales, one subscale covers symptoms of anxiety (HADS-A), the other symptoms of depression (HADS-D). Each item is scored from zero ("not applicable") to three ("certainly applicable"). The maximum score on each subscale is 21, with higher values indicating more anxiety/depression symptoms.

    Time frame: 3 months after THA

  23. Hospital Anxiety and Depression Scale (HADS)

    The HADS is a 14-item questionnaire evaluating anxiety and depression complaints without involving physical complaints. The HADS consists of two subscales, one subscale covers symptoms of anxiety (HADS-A), the other symptoms of depression (HADS-D). Each item is scored from zero ("not applicable") to three ("certainly applicable"). The maximum score on each subscale is 21, with higher values indicating more anxiety/depression symptoms.

    Time frame: 12 months after THA

  24. Fear-Avoidance Component Scale (FACS)

    Pain-related fear avoidance was assessed by the Dutch version of the FACS, which is a 20-item questionnaire, with each item scored on a 6-point Likert scale, resulting in scores ranging from zero ("completely disagree") to five ("completely agree"). There is a maximum total score of 100, with higher scores indicating more fear-avoidance. Five fear-avoidance-related severity levels have been proposed: subclinical (0 to 20), mild (21 to 40), moderate (41 to 60), severe (61 to 80), and extreme (81 to 100).

    Time frame: 1 week before THA

  25. Fear-Avoidance Component Scale (FACS)

    Pain-related fear avoidance was assessed by the Dutch version of the FACS, which is a 20-item questionnaire, with each item scored on a 6-point Likert scale, resulting in scores ranging from zero ("completely disagree") to five ("completely agree"). There is a maximum total score of 100, with higher scores indicating more fear-avoidance. Five fear-avoidance-related severity levels have been proposed: subclinical (0 to 20), mild (21 to 40), moderate (41 to 60), severe (61 to 80), and extreme (81 to 100).

    Time frame: 1 week after THA

  26. Fear-Avoidance Component Scale (FACS)

    Pain-related fear avoidance was assessed by the Dutch version of the FACS, which is a 20-item questionnaire, with each item scored on a 6-point Likert scale, resulting in scores ranging from zero ("completely disagree") to five ("completely agree"). There is a maximum total score of 100, with higher scores indicating more fear-avoidance. Five fear-avoidance-related severity levels have been proposed: subclinical (0 to 20), mild (21 to 40), moderate (41 to 60), severe (61 to 80), and extreme (81 to 100).

    Time frame: 6 weeks after THA

  27. Fear-Avoidance Component Scale (FACS)

    Pain-related fear avoidance was assessed by the Dutch version of the FACS, which is a 20-item questionnaire, with each item scored on a 6-point Likert scale, resulting in scores ranging from zero ("completely disagree") to five ("completely agree"). There is a maximum total score of 100, with higher scores indicating more fear-avoidance. Five fear-avoidance-related severity levels have been proposed: subclinical (0 to 20), mild (21 to 40), moderate (41 to 60), severe (61 to 80), and extreme (81 to 100).

    Time frame: 3 months after THA

  28. Fear-Avoidance Component Scale (FACS)

    Pain-related fear avoidance was assessed by the Dutch version of the FACS, which is a 20-item questionnaire, with each item scored on a 6-point Likert scale, resulting in scores ranging from zero ("completely disagree") to five ("completely agree"). There is a maximum total score of 100, with higher scores indicating more fear-avoidance. Five fear-avoidance-related severity levels have been proposed: subclinical (0 to 20), mild (21 to 40), moderate (41 to 60), severe (61 to 80), and extreme (81 to 100).

    Time frame: 12 months after THA

  29. Tampa Scale for Kinesiophobia (TSK-17)

    Pain-related fear of movement was assessed with the 17-item version of the TSK. Each item is scored on a 4-point Likert Scale, ranging from one ("strongly disagree") to four ("strongly agree"). The total score ranges between 17 and 68, with higher values reflecting greater fear of movement.

    Time frame: 1 week before THA

  30. Tampa Scale for Kinesiophobia (TSK-17)

    Pain-related fear of movement was assessed with the 17-item version of the TSK. Each item is scored on a 4-point Likert Scale, ranging from one ("strongly disagree") to four ("strongly agree"). The total score ranges between 17 and 68, with higher values reflecting greater fear of movement.

    Time frame: 1 week after THA

  31. Tampa Scale for Kinesiophobia (TSK-17)

    Pain-related fear of movement was assessed with the 17-item version of the TSK. Each item is scored on a 4-point Likert Scale, ranging from one ("strongly disagree") to four ("strongly agree"). The total score ranges between 17 and 68, with higher values reflecting greater fear of movement.

    Time frame: 6 weeks after THA

  32. Tampa Scale for Kinesiophobia (TSK-17)

    Pain-related fear of movement was assessed with the 17-item version of the TSK. Each item is scored on a 4-point Likert Scale, ranging from one ("strongly disagree") to four ("strongly agree"). The total score ranges between 17 and 68, with higher values reflecting greater fear of movement.

    Time frame: 3 months after THA

  33. Tampa Scale for Kinesiophobia (TSK-17)

    Pain-related fear of movement was assessed with the 17-item version of the TSK. Each item is scored on a 4-point Likert Scale, ranging from one ("strongly disagree") to four ("strongly agree"). The total score ranges between 17 and 68, with higher values reflecting greater fear of movement.

    Time frame: 12 months after THA

  34. Injustice Experience Questionnaire (IEQ)

    Perceived injustice was measured with the Injustice Experience Questionnaire (IEQ). The IEQ consists of 12 items, each item is scored from zero ("not at all") to four (all the time"). The total score ranges between 0 and 48 and higher total scores reflect higher levels of perceived injustice.

    Time frame: 1 week before THA

  35. Injustice Experience Questionnaire (IEQ)

    Perceived injustice was measured with the Injustice Experience Questionnaire (IEQ). The IEQ consists of 12 items, each item is scored from zero ("not at all") to four (all the time"). The total score ranges between 0 and 48 and higher total scores reflect higher levels of perceived injustice.

    Time frame: 1 week after THA

  36. Injustice Experience Questionnaire (IEQ)

    Perceived injustice was measured with the Injustice Experience Questionnaire (IEQ). The IEQ consists of 12 items, each item is scored from zero ("not at all") to four (all the time"). The total score ranges between 0 and 48 and higher total scores reflect higher levels of perceived injustice.

    Time frame: 6 weeks after THA

  37. Injustice Experience Questionnaire (IEQ)

    Perceived injustice was measured with the Injustice Experience Questionnaire (IEQ). The IEQ consists of 12 items, each item is scored from zero ("not at all") to four (all the time"). The total score ranges between 0 and 48 and higher total scores reflect higher levels of perceived injustice.

    Time frame: 3 months after THA

  38. Injustice Experience Questionnaire (IEQ)

    Perceived injustice was measured with the Injustice Experience Questionnaire (IEQ). The IEQ consists of 12 items, each item is scored from zero ("not at all") to four (all the time"). The total score ranges between 0 and 48 and higher total scores reflect higher levels of perceived injustice.

    Time frame: 12 months after THA

  39. General Self-Efficacy Scale (GSES)

    The General Self-Efficacy Scale is a self-reported questionnaire used to measure self-efficacy. The GSES measures how a person generally copes with stressors/difficult situations in life. It consists of ten statements (optimistic "self-beliefs") that ask about how people think and act in general. Items are scored on a 4-point Likert scale.

    Time frame: 1 week before THA

  40. General Self-Efficacy Scale (GSES)

    The General Self-Efficacy Scale is a self-reported questionnaire used to measure self-efficacy. The GSES measures how a person generally copes with stressors/difficult situations in life. It consists of ten statements (optimistic "self-beliefs") that ask about how people think and act in general. Items are scored on a 4-point Likert scale.

    Time frame: 6 weeks after THA

  41. General Self-Efficacy Scale (GSES)

    The General Self-Efficacy Scale is a self-reported questionnaire used to measure self-efficacy. The GSES measures how a person generally copes with stressors/difficult situations in life. It consists of ten statements (optimistic "self-beliefs") that ask about how people think and act in general. Items are scored on a 4-point Likert scale.

    Time frame: 3 months after THA

  42. General Self-Efficacy Scale (GSES)

    The General Self-Efficacy Scale is a self-reported questionnaire used to measure self-efficacy. The GSES measures how a person generally copes with stressors/difficult situations in life. It consists of ten statements (optimistic "self-beliefs") that ask about how people think and act in general. Items are scored on a 4-point Likert scale.

    Time frame: 12 months after THA

  43. Groningen Orthopaedic Social Support Scale (GO-SSS)

    The 'Groningen Orthopedic Social Support Scale' is a self-reported questionnaire that has been developed to measure social support in patients with a THA or TKP. Social support is measured through 12 statements where the patient can choose from four answers: 'never or rarely', 'occasionally', 'regularly' or 'often'.

    Time frame: 1 week before THA

  44. Groningen Orthopaedic Social Support Scale (GO-SSS)

    The 'Groningen Orthopedic Social Support Scale' is a self-reported questionnaire that has been developed to measure social support in patients with a THA or TKP. Social support is measured through 12 statements where the patient can choose from four answers: 'never or rarely', 'occasionally', 'regularly' or 'often'.

    Time frame: 6 weeks after THA

  45. Groningen Orthopaedic Social Support Scale (GO-SSS)

    The 'Groningen Orthopedic Social Support Scale' is a self-reported questionnaire that has been developed to measure social support in patients with a THA or TKP. Social support is measured through 12 statements where the patient can choose from four answers: 'never or rarely', 'occasionally', 'regularly' or 'often'.

    Time frame: 3 months after THA

  46. Groningen Orthopaedic Social Support Scale (GO-SSS)

    The 'Groningen Orthopedic Social Support Scale' is a self-reported questionnaire that has been developed to measure social support in patients with a THA or TKP. Social support is measured through 12 statements where the patient can choose from four answers: 'never or rarely', 'occasionally', 'regularly' or 'often'.

    Time frame: 12 months after THA

  47. Muscle strength

    Hip muscle strength will be measured with the MicroFet 2®, a handheld dynamometer. In the test protocol, each muscle group will be tested three times, with the best value of the three tests as the final result. The following muscle groups will be tested: * Hip flexors * Hip abductors * Hip extensors * Hip external rotators * Hip adductors

    Time frame: 1 week before THA

  48. Muscle strength

    Hip muscle strength will be measured with the MicroFet 2®, a handheld dynamometer. In the test protocol, each muscle group will be tested three times, with the best value of the three tests as the final result. The following muscle groups will be tested: * Hip flexors * Hip abductors * Hip extensors * Hip external rotators * Hip adductors

    Time frame: 6 weeks after THA

  49. Muscle strength

    Hip muscle strength will be measured with the MicroFet 2®, a handheld dynamometer. In the test protocol, each muscle group will be tested three times, with the best value of the three tests as the final result. The following muscle groups will be tested: * Hip flexors * Hip abductors * Hip extensors * Hip external rotators * Hip adductors

    Time frame: 3 months after THA

  50. Muscle strength

    Hip muscle strength will be measured with the MicroFet 2®, a handheld dynamometer. In the test protocol, each muscle group will be tested three times, with the best value of the three tests as the final result. The following muscle groups will be tested: * Hip flexors * Hip abductors * Hip extensors * Hip external rotators * Hip adductors

    Time frame: 12 months after THA

  51. Perceived stress

    Perceived stress will be evaluated with a single question of the Perceived Stress Scale (PSS): 'During the past day, how often have you felt nervous and stressed?'. The question is scored on a 5-point Likert scale, from 0 'never' to 4 'very often'.

    Time frame: 1 week before THA

  52. Perceived stress

    Perceived stress will be evaluated with a single question of the Perceived Stress Scale (PSS): 'During the past day, how often have you felt nervous and stressed?'. The question is scored on a 5-point Likert scale, from 0 'never' to 4 'very often'.

    Time frame: 1 day after THA

  53. Perceived stress

    Perceived stress will be evaluated with a single question of the Perceived Stress Scale (PSS): 'During the past day, how often have you felt nervous and stressed?'. The question is scored on a 5-point Likert scale, from 0 'never' to 4 'very often'.

    Time frame: 3 days after THA

  54. Perceived stress

    Perceived stress will be evaluated with a single question of the Perceived Stress Scale (PSS): 'During the past day, how often have you felt nervous and stressed?'. The question is scored on a 5-point Likert scale, from 0 'never' to 4 'very often'.

    Time frame: 5 days after THA

  55. Perceived stress

    Perceived stress will be evaluated with a single question of the Perceived Stress Scale (PSS): 'During the past day, how often have you felt nervous and stressed?'. The question is scored on a 5-point Likert scale, from 0 'never' to 4 'very often'.

    Time frame: 7 days after THA

  56. Perceived stress

    Perceived stress will be evaluated with a single question of the Perceived Stress Scale (PSS): 'During the past day, how often have you felt nervous and stressed?'. The question is scored on a 5-point Likert scale, from 0 'never' to 4 'very often'.

    Time frame: 6 weeks after THA

  57. Perceived stress

    Perceived stress will be evaluated with a single question of the Perceived Stress Scale (PSS): 'During the past day, how often have you felt nervous and stressed?'. The question is scored on a 5-point Likert scale, from 0 'never' to 4 'very often'.

    Time frame: 3 months after THA

  58. Perceived stress

    Perceived stress will be evaluated with a single question of the Perceived Stress Scale (PSS): 'During the past day, how often have you felt nervous and stressed?'. The question is scored on a 5-point Likert scale, from 0 'never' to 4 'very often'.

    Time frame: 12 months after THA

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05265858
Lead sponsor
Hasselt University
Collaborators
Bijzonder onderzoeksfonds (BOF), Ziekenhuis Oost-Limburg
Responsible party
Annick Timmermans (Professor, Hasselt University) — Principal investigator
First posted
Mar 4, 2022
Start date
May 4, 2021
Primary completion
Feb 2024 (estimated)
Completion
Feb 2024 (estimated)
Last update
Mar 4, 2022

Study contacts

Abner Sergooris
Contact
abner.sergooris@uhasselt.be
003211299187
Annick Timmermans
Contact
annick.timmermans@uhasselt.be
003211292125
Annick Timmermans
principal investigator · Hasselt University
Kristoff Corten
principal investigator · Ziekenhuis Oost-Limburg
Katleen Bogaerts
principal investigator · Hasselt University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion