An interventional study of Anterior approach and Posterolateral approach in Loosening, Prosthesis, sponsored by Reinier Haga Orthopedisch Centrum. Enrolling by invitation at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-13.
Sponsored by Reinier Haga Orthopedisch Centrum · Not applicable, Interventional, and Treatment
With increasing numbers of total hip arthroplasties performed each year, the incidence of problems related to loosening and wear of total hip arthroplasties is expected to also increase. While the anterior approach for primary total hip arthroplasty has demonstrated to result in a faster short-term recovery than the traditional lateral and posterior approach, this effect has not yet been investigated in revision surgery. Accelerating functional outcome may increase patient satisfaction and reduce healthcare costs.
The primary objective is to assess whether isolated cup revision surgery through the anterior approach results in increased functional status and higher patient satisfaction than through the posterolateral approach.
This is a prospective Randomized Controlled Trial (RCT) in which 68 patients will be included (34 per group). Patients will be evaluated preoperatively and 6 weeks, 3 months and 1 year postoperatively.
The main endpoints are functional recovery as measured with the 30-sec Chair Stand Test (30s-CST), 40m Fast Paced Walking Test (40m FPWT) and the Stair Climb Test (SCT).
Secondary endpoints are Modified Borg scale outcomes after the functional tests, Numeric Rating Scale (NRS) for pain (rest/movement), Oxford Hip Score (OHS), HOOS-PS, EQ-5D-5L, satisfaction, cup inclination and complications at 30 days and 90 days postoperatively.
119 studies on the registry are indexed under Prosthesis Failure; 35 are open to participants now.
This study's planned enrollment of 68 is above the median of 36 across 69 interventional studies indexed under Prosthesis Failure.
Browse Prosthesis Failure studies →Reinier Haga Orthopedisch Centrum is the lead sponsor of 12 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cup revision surgery through the anterior approach
Procedure: Anterior approach
Cup revision surgery through the posterolateral approach
Procedure: Posterolateral approach
Anterior approach
Posterolateral approach
Change from baseline 30-sec Chair Stand Test (30s-CST) at 6 weeks
The 30 second Chair Stand Test (30s-CST) is designed to test the sit-to-stand activity, incorporating lower body strength and dynamic balance, and measures the maximum number of chair stand repetitions possible in a 30 second period. It is part of the core set of tests to assess physical function in patients with hip or knee osteoarthritis or following joint arthroplasty, as recommended by the Osteoarthritis Research Society International (OARSI).
Time frame: 6 weeks postoperatively
Change from baseline 40m Fast Paced Walk Test (40m FPWT) at 6 weeks
The 40m Fast Paced Walk Test (40m FPWT) tests walking speed over short distances and changing directions during walking. It is timed over 4 x 10 meters, for a total of 40 meters. It is part of the core set of tests to assess physical function in patients with hip or knee osteoarthritis or following joint arthroplasty, as recommended by the Osteoarthritis Research Society International (OARSI).
Time frame: 6 weeks postoperatively
Change from baseline Stair Climb Test (SCT) at 6 weeks
The Stair Climb Test (SCT) is designed to test ascending and descending stair activity, and measures the time in seconds to ascend and descend a flight of stairs. It is part of the core set of tests to assess physical function in patients with hip or knee osteoarthritis or following joint arthroplasty, as recommended by the Osteoarthritis Research Society International (OARSI).
Time frame: 6 weeks postoperatively
Change from baseline Modified Borg Rating of Perceived Exertion (RPE) scale outcome during 30s-CST at 6 weeks, 3 months and 1 year
We will use the Borg RPE scale to assess the patients' perception of effort during the functional tasks
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Change from Modified Borg Rating of Perceived Exertion (RPE) scale outcome during 40m FPWT at 6 weeks, 3 months and 1 year
We will use the Borg RPE scale to assess the patients' perception of effort during the functional tasks
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Change from Modified Borg Rating of Perceived Exertion (RPE) scale outcome during SCT at 6 weeks, 3 months and 1 year
We will use the Borg RPE scale to assess the patients' perception of effort during the functional tasks
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Change from baseline 30-sec Chair Stand Test (30s-CST) at 6 weeks, 3 months and 1 year
The 30 second Chair Stand Test (30s-CST) is designed to test the sit-to-stand activity, incorporating lower body strength and dynamic balance, and measures the maximum number of chair stand repetitions possible in a 30 second period. It is part of the core set of tests to assess physical function in patients with hip or knee osteoarthritis or following joint arthroplasty, as recommended by the Osteoarthritis Research Society International (OARSI).
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively
Change from baseline 40m Fast Paced Walk Test (40m FPWT) at 6 weeks, 3 months and 1 year
The 40m Fast Paced Walk Test (40m FPWT) tests walking speed over short distances and changing directions during walking. It is timed over 4 x 10 meters, for a total of 40 meters. It is part of the core set of tests to assess physical function in patients with hip or knee osteoarthritis or following joint arthroplasty, as recommended by the Osteoarthritis Research Society International (OARSI).
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively
Change from baseline Stair Climb Test (SCT) at 6 weeks, 3 months and 1 year
The Stair Climb Test (SCT) is designed to test ascending and descending stair activity, and measures the time in seconds to ascend and descend a flight of stairs. It is part of the core set of tests to assess physical function in patients with hip or knee osteoarthritis or following joint arthroplasty, as recommended by the Osteoarthritis Research Society International (OARSI).
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively
Patient reported outcome measure: Pain at rest
Measured using Numeric Rating Scale (NRS) for pain at rest
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Patient reported outcome measure: Pain during movement
Measured using Numeric Rating Scale (NRS) for pain during movement
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Patient reported outcome measure: Oxford Hip Score (OHS)
The Oxford Hip Score (OHS) is a hip specific questionnaire, consisting of 12 items concerning pain and daily functions. In the original scoring, each question is scored on a 5-point Likert scale, ranging from 1 (no pain/easy to do) to 5 (unbearable/impossible to do). The original total score ranges from 12 (best) to 60 (worst) points. It has been developed for total hip surgery. In the revised scoring, each question is scored from 0 (worst) to 4 (best), ranging the total score from 0 (worst) to 48 (best) (20). The revised scoring will be used in this study.
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Patient reported outcome measure: HOOS-PS
The HOOS-PS is a short measure of physical function for hip osteoarthritis (OA), derived from the original, longer, Hip disability and Osteoarthritis Outcome Score (HOOS). The raw scoring ranges from 0 (none) to 4 (extreme) per question, for a total raw score range of 0 to 20 (lower is less difficulty). The person interval level score ranges, which can be calculated from the total raw score using a nomogram, ranges from 0 (no difficulty) to 100 (extreme difficulty).
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Patient reported outcome measure: EQ-5D-5L
EuroQol-5D (EQ-5D) is a general health-related quality of life questionnaire and consists of five questions regarding mobility, self-care, usual activities, pain/discomfort and anxiety/depression and one visual analog scale (VAS) to document the perceived quality of life. It is also used to assess quality adjusted life years (QALY).
Time frame: Preoperatively, and 6 weeks, 3 months and 1 year postoperatively.
Patient reported outcome measure: Satisfaction
Anchor question regarding how satisfied the subject is (in general) with the results of his/her hip surgery?
Time frame: 6 weeks, 3 months and 1 year postoperatively.
Cup inclination
Categorized into ≤35°, 35° - 45° and ≥45°
Time frame: 6 weeks postoperatively
Complications
Postoperative complications as recorded in the electronic patient file
Time frame: 30 days postoperatively and 90 days postoperatively
Lowgrade infection
To investigate selection bias caused by loss to follow up, the investigators will also record whether a lowgrade infection was determined during or after revision surgery.
Time frame: 6 weeks, 3 months and 1 year postoperatively.
Started Sep 2022 (actual). Primary completion is estimated for Feb 2026, 41 months after the start.
Of 48 non-industry interventional studies with no phase under Prosthesis Failure, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 51. This study's planned 41 months is above that.
Counting every sponsor, half of 50 studies reached it within 18 months; a quarter within 9 and three quarters within 42.
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Reinier Haga Orthopedisch Centrum