ClinicalTrials.gg
Not yet recruitingNCT07834034DARTUpdated Sep 22, 2026

Daycase Hip and Knee Arthroplasty in Møre and Romsdal Trial

An observational study in Knee Osteoarthritis, Hip Osteoarthritis and Osteonecrosis, sponsored by Helse Møre og Romsdal HF. Not yet recruiting at 3 sites in Norway. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Helse Møre og Romsdal HF · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The DART Study is a prospective, multicentre observational cohort study evaluating day-case pathways for patients undergoing primary total hip arthroplasty, total knee arthroplasty, or unicompartmental knee arthroplasty at three hospitals in Møre og Romsdal, Norway (Volda, Ålesund and SNR). All patients scheduled for these procedures will be screened for eligibility for same-day discharge using predefined clinical, functional, and logistical criteria.

The primary objective is to determine the proportion of patients who are discharged on the day of surgery. Secondary objectives are to assess recovery, pain, complications, emergency department visits, readmissions, reoperations, and mortality during the first 30 days after surgery. Patient-reported outcomes, including quality of recovery, joint-specific function, quality of life, pain, and awareness of the joint replacement, will be assessed before surgery and during follow-up for up to three months.

Clinical and patient-reported data will be collected prospectively. Outcomes for patients discharged on the day of surgery will be compared with those of patients who remain in hospital overnight or longer. The study aims to evaluate the feasibility, safety, and patient experience of implementing standardized day-case hip and knee arthroplasty pathways within routine clinical practice.

Read the detailed description

The increasing demand for hip and knee arthroplasty has created a need for more efficient perioperative pathways without compromising patient safety, recovery, or satisfaction. Advances in surgical technique, anaesthesia, multimodal analgesia, early mobilization, and structured follow-up have made discharge on the day of surgery feasible for selected patients. However, the proportion of patients who can complete a day-case pathway in routine clinical practice, and the reasons why intended same-day discharge is not achieved, may vary between hospitals and patient populations.

The DART Study will evaluate the implementation of a standardized day-case arthroplasty pathway across three hospitals within Møre og Romsdal Hospital Trust: Sjukehuset Nordmøre og Romsdal at Hjelset, Ålesund Hospital, and Volda Hospital. The study will include patients scheduled for primary total hip arthroplasty, total knee arthroplasty, or unicompartmental knee arthroplasty. The study is investigator-initiated and embedded in ordinary clinical care.

All patients scheduled for one of the eligible procedures during the recruitment period will be screened prospectively. Screening will document whether the patient fulfils the predefined criteria for participation in the day-case pathway.

The predefined eligibility assessment will include relevant medical, functional, cognitive, and logistical factors. Factors expected to preclude participation in the day-case pathway include severe systemic disease, advanced frailty, impaired cognition or inability to comply with instructions, body mass index above 40 kg/m², age above 80 years, and travel circumstances that make rapid access to an acute hospital difficult. Final eligibility will be determined by the treating clinical team according to the study criteria and an individual clinical assessment.

Patients included in the day-case pathway will receive standardized preoperative information and preparation. The perioperative pathway is designed to support early recovery and includes evidence-based anaesthesia, multimodal opioid-sparing analgesia, early oral intake, and mobilization shortly after surgery. Regional analgesic techniques will be adapted to the type of procedure. Patients undergoing knee arthroplasty will receive a genicular nerve block and femoral triangle block as part of the pain-management pathway. Patients undergoing total hip arthroplasty will receive a pericapsular nerve group block. The use and effect of the regional block will be documented. After a pericapsular nerve group block, the ability to perform active knee extension while sitting will be assessed as an indicator of quadriceps motor function.

After surgery, patients will be transferred to a dedicated postoperative day unit. Readiness for discharge will be assessed using standardized clinical criteria. These will include stable vital signs, satisfactory control of pain and nausea, ability to eat and drink, satisfactory urinary function when clinically required, safe mobilization with an appropriate walking aid, and the presence of adequate support after discharge. Patients must also understand the medication plan, postoperative instructions, warning symptoms, and whom to contact if problems occur.

Discharge on the day of surgery will be attempted only when the discharge criteria are fulfilled and both the patient and the responsible clinical team consider discharge appropriate. Patients who do not fulfil the criteria, develop a clinical problem, or do not feel ready to leave hospital will remain admitted according to usual clinical practice. The reason for an overnight stay or prolonged admission will be documented. Potential reasons may include pain, nausea or vomiting, dizziness, delayed mobilization, urinary retention, wound-related concerns, medical instability, logistical factors, or patient preference.

The study will record the time of discharge and classify patients according to whether they were discharged on the day of surgery or stayed in hospital overnight or longer. Same-day discharge will be defined as discharge to the patient's usual place of residence on the calendar day of surgery without an overnight hospital stay.

Baseline data will include age, sex, body mass index, American Society of Anesthesiologists physical status classification, Clinical Frailty Scale score, diagnosis, operated side, type of arthroplasty, and pain intensity. Relevant perioperative and surgical information will also be collected, including the regional analgesic technique, postoperative motor function where applicable, pain during rest and mobilization, and time of discharge.

Patient-reported outcome measures will be collected electronically at predefined time points. Before surgery, patients will complete joint-specific outcome measures according to the operated joint. Knee patients will complete the Knee injury and Osteoarthritis Outcome Score, and hip patients will complete the Hip disability and Osteoarthritis Outcome Score. Patients will also complete the Forgotten Joint Score, EuroQol 5-Dimension questionnaire, and numerical rating scales for pain.

Early postoperative recovery will be assessed using the Norwegian version of the 15-item Quality of Recovery questionnaire. This questionnaire will be administered on the day of surgery, on postoperative day 1, on postoperative day 3 and 7. Pain intensity at rest and during activity or mobilization will be recorded using numerical rating scales. Patients will keep a pain diary during the first postoperative week. Use of rescue opioid medication, including the number of immediate-release oxycodone tablets taken after discharge, will be recorded.

Patients will be contacted by telephone on the first postoperative day. The telephone consultation will assess general recovery, pain, medication use, possible complications, and the need for additional medical advice or assessment. Further follow-up will be conducted at approximately 7 days, 30 days, and 3 months after surgery.

Postoperative complications will be recorded prospectively and graded according to the Clavien-Dindo classification. Events of particular interest include venous thromboembolism, pulmonary embolism, myocardial infarction, stroke, surgical-site or periprosthetic infection, urinary retention, urinary tract infection, pneumonia, wound complications, and other medical or surgical events requiring treatment. For each complication, the study team will assess whether the event may be related to the day-case pathway.

Unplanned contacts with healthcare services will be documented, including telephone consultations, visits to a general practitioner, out-of-hours medical services, emergency department visits, and hospital admissions. Hospital readmissions within 30 days will be classified as all-cause readmissions and, where possible, as related or unrelated to same-day discharge. Reoperations and mortality will also be recorded.

At 3 months, recovery will be assessed using pain scores, quality-of-recovery assessment, joint-specific patient-reported outcomes, Forgotten Joint Score, and EuroQol 5-Dimension. These data will provide information on whether early discharge is associated with satisfactory short-term recovery and patient-reported health status.

The main analyses will be descriptive and will reflect implementation of the pathway in routine practice. The proportion of screened patients who fulfil the day-case eligibility criteria will be reported, together with the proportion of eligible patients who achieve same-day discharge. Reasons for exclusion from the pathway and reasons for unsuccessful same-day discharge will be summarized.

Patient characteristics, perioperative factors, early recovery, complications, healthcare contacts, readmissions, and patient-reported outcomes will be described for the study population. Outcomes may also be compared between patients discharged on the day of surgery and patients who remain in hospital overnight or longer. Exploratory analyses may be used to identify patient-related, procedural, logistical, or perioperative factors associated with successful same-day discharge.

Because discharge is determined by clinical readiness and not by random allocation, comparisons between discharge groups will be interpreted as observational associations. Statistical analyses may therefore include adjustment for relevant baseline differences, such as age, sex, body mass index, comorbidity, frailty, procedure type, and hospital.

The study is expected to include approximately 2-300 patients, with representation from both hip and knee arthroplasty pathways. Recruitment will continue for approximately 12 months if the planned number of participants is reached and may be extended to a maximum of approximately 18 months if necessary.

The DART Study will provide detailed information on patient selection, pathway completion, early recovery, safety events, and healthcare use after implementation of day-case hip and knee arthroplasty in a regional hospital system. The results are intended to support further refinement of patient-selection criteria, perioperative care, discharge procedures, and follow-up arrangements for day-case arthroplasty.

02

Conditions studied

  • Knee Osteoarthritis
  • Hip Osteoarthritis
  • Osteonecrosis
  • Osteoarthritis

Keywords

  • Daycase
  • Daycase arthroplasty surgery
  • ambulatory surgery
  • Total hip arthroplasty
  • total knee arthroplasty
  • total hip replacement
  • unicondylar knee arthroplasty
  • UKA
  • THA
  • THR
  • TKA
  • TKR
  • daycare arthroplasty
03

In context

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

This study's planned enrollment of 300 is above the median of 100 across 486 observational studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Helse Møre og Romsdal HF is the lead sponsor of 24 studies on the registry; 7 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study population will consist of consecutive adult patients (18 - 80 years old) scheduled for primary total hip arthroplasty, total knee arthroplasty, or unicompartmental knee arthroplasty at the participating hospitals in Møre og Romsdal, Norway. All patients undergoing an eligible procedure during the recruitment period will be prospectively screened for suitability for the standardized day-case pathway. Patients who meet the predefined clinical, functional, cognitive, and logistical eligibility criteria and provide informed consent will be included in the prospective cohort.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients 18-80 years old scheduled for primary TKA, UKA or THA

Exclusion criteria

Exclusion Criteria:

  • Patient not motivated for daycase surgery, lack of adult caregiver staying with the patient for the first 24 hours post-discharge, 3 (if not approved by anesthesiologist) and 4, travel distance to acute hospital no more than 1 hour (ferry-free), dementia or other reasons for lacking compliance (e.g. substance abuse, severe psychiatric disorder etc.) >40 kg/m2, patients with anticipated high level of pain due to previous experience, comorbidity (i.e. chronic pain syndrome, fibromyalgia), patients treated with opoid analgesics on a regular basis prior to surgery.
Terms in these criteria, in plain language(2)

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.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • Total Hip Arthroplasty

    Eligable patients for daycase surgery with hip osteoarthritis, osteonecrosis or other indication for total hip arthroplasty

    Procedure: Total Hip Arthroplasty

  • Total Knee Arthroplasty

    Eligable patients for daycase surgery with knee osteoarthritis, osteonecrosis or other indication for total knee arthroplasty

    Procedure: Total Knee Arthroplasty

  • Unicondylar Knee Arthroplasty

    Eligable patients for daycase surgery with knee osteoarthritis, osteonecrosis or other indication for unicondylar knee arthroplasty

    Procedure: Unicondylar knee artrhoplasty

Interventions

  • ProcedureTotal Hip Arthroplasty

    Total arthroplasty replacement of the hip through anterior or posterior approach. Cemented, hybrid, reverse hybrid or cementless implants. Patients with this procedure will receive Pericapsular Nerve Group Block (PENG) by an aneaesthesiologist.

  • ProcedureTotal Knee Arthroplasty

    Total artrohplasty replacement of the knee with or without patella resurfacing, and with or without tourniquet. Cemented, hybrid, reverse hybrid or cementless implants. Patients with this procedure will receive a femoral triangle block and genicular nerve blocks by an anaesthesiologist.

  • ProcedureUnicondylar knee artrhoplasty

    Uniconcylar artrohplasty of the knee with or without tourniquet. Cemented, hybrid, reverse hybrid or cementless implants. Patients with this procedure will receive a femoral triangle block and genicular nerve blocks by an anaesthesiologist.

06

What researchers measure

Primary outcomes

  1. Proportion of same day discharge

    The proportion of patients that are not dicharged at the day of surgery, but are admitted to the ward for som reason including complications, social factors , PONV, pain etc. It does also include the patients readmitted on the day of surgery.

    Time frame: The primary outcome measure is measured at the day of surgery. If by any chance a patient is readmitted to hospital the day after surgery, this is counted as a readmission.

Secondary outcomes

  1. Knee Injury and Osteoarthritis Outcome Score

    42 item PROM measuring 5 dimensions including pain, symptoms, ADL, sport and recreation and knee-related quality of life . Each question is measured on a likert scale from 0 to 4. Every part score is calculated separate and 100 means no symptoms, 0 severe problems.

    Time frame: Preoperative and 3 months postoperative

  2. The Forgotten Joint Score (FJS) Knee

    The FJS-12 Knee is a 12-item patient-reported questionnaire assessing the patient's awareness of the operated knee during everyday activities. Scores range from 0 to 100, with higher scores indicating less awareness of the knee prosthesis and a better outcome

    Time frame: Preoperative and 3 months postoperative

  3. The Forgotten Joint Score (FJS) Hip

    The FJS-12 Hip is a 12-item patient-reported questionnaire assessing the patient's awareness of the operated hip during everyday activities. Scores range from 0 to 100, with higher scores indicating less awareness of the hip prosthesis and a better outcome.

    Time frame: Preoperative and 3 months postoperative

  4. Clinical Frailty Scale

    The Clinical Frailty Scale is a clinician-rated measure of overall fitness and frailty based on mobility, function, comorbidity, and dependence in activities of daily living. Scores range from 1 to 9, where 1 indicates very fit and 9 indicates terminally ill. Higher scores represent greater frailty.

    Time frame: Baseline

  5. Hip disability and Osteoarthritis Outcome Score (HOOS)

    The HOOS is a patient-reported questionnaire assessing hip-related symptoms and function. It includes five subscales: Pain, Symptoms, Activities of Daily Living, Sport and Recreation Function, and Hip-related Quality of Life. Each subscale is scored from 0 to 100, with higher scores indicating fewer symptoms and better hip function.

    Time frame: Preoperative and 3 months postoperative

  6. Quality of Recovery

    The QoR-15 is a 15-item patient-reported questionnaire assessing early postoperative recovery across five domains: physical comfort, emotional state, physical independence, psychological support, and pain. The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.

    Time frame: Baseline, Postoperative day 1, 3 and 7, 1 month and 3 months

  7. Numeric rating scale for pain (NRS)

    The NRS is an 11-point patient-reported scale used to assess pain intensity. Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain may be assessed separately at rest and during activity or mobilization.

    Time frame: Prepoerative, before discharge after surgery, postoperative day 1-7, 1 and 3 months postoperative.

  8. Proportion of resubmission

    Proportion of patients who are subject to resubmission of any reason after surgery

    Time frame: postoperative day 1, day 7, 1 and 3 months

  9. Serious adverse events (SAE)

    Patients subject to serous adverse events after surgery. The complications will be dichotomized into likely to be daycase dependent or not.

    Time frame: Up to 3 months after surgery

  10. EQ-5D

    The EQ-5D is a standardized patient-reported outcome measure used to assess health-related quality of life. It evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Patients also rate their overall health on a visual analogue scale from 0, representing the worst imaginable health, to 100, representing the best imaginable health. Responses can be converted into a health utility index, with higher scores indicating better health-related quality of life.

    Time frame: Preoperative and 3 months postoperative

  11. Claudien-Dindo classification

    Grading of the potential complications from 1 to 5.

    Time frame: peroperativ, 1 day postoperative, 7 days postoperative, 30 days postoperative and 3 months postoperative

07

Study locations

3 sites
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — Individual participant data will not be shared because the dataset contains sensitive health information collected within a defined regional patient population. Even after removal of direct identifiers, there may be a risk of participant re-identification through combinations of clinical, procedural, and follow-up variables. Data sharing is also restricted by the informed consent, ethical approval, institutional data-governance requirements, and applicable data-protection legislation. Access to the study data will therefore be limited to authorized members of the research team and approved collaborators.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07834034
Lead sponsor
Helse Møre og Romsdal HF
Responsible party
Sponsor
First posted
Sep 22, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Oct 1, 2028 (estimated)
Completion
Jul 31, 2036 (estimated)
Last update
Sep 22, 2026

Study contacts

Myrthle S Hoel, Study nurse
Contact
myhrtle.slettvag.hoel@helse-mr.no
004771121943
Erik Ostnes, MD
Contact
erik.ostnes@helse-mr.no
004770105000
Frank-David Øhrn, MD, PhD
study chair · Nordmøre and Romsdal Hospital, Møre and Romsdal Hospital Trust
Frank-David Øhrn, MD, PhD
principal investigator · Nordmøre and Romsdal Hospital, Møre and Romsdal Hospital Trust

Oversight

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

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