Knee OsteoarthritisDARTNCT07834034
Daycase Hip and Knee Arthroplasty in Møre and Romsdal Trial
An observational study of Knee Osteoarthritis and Hip Osteoarthritis, run by Helse Møre og Romsdal HF at 3 sites in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Hip Osteoarthritis, Osteonecrosis
- What is being tested?
- Total Hip Arthroplasty, Total Knee Arthroplasty and Unicondylar knee artrhoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 3 sitesNorway
- Study dates
- 1 Oct 2026to 31 Jul 2036
- How long will I take part?
- 3 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients 18-80 years old scheduled for primary TKA, UKA or THA
Who cannot join
- Patient not motivated for daycase surgery, lack of adult caregiver staying with the patient for the first 24 hours post-discharge, ASA class 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.) BMI >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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Norway3 sites
Ålesund Sjukehus
Ålesund, Møre and Romsdal
Ole C Roth, MD, 004770105000, ole.christian.roth@helse-mr.no
Raymond Nilsen, MD, 004770105000, Raymond.Nilsen@helse-mr.no
Nordmøre and Romsdal Hospital (SNR) Hjelset
Hjelset, Møre and Romsdal, 6450
Myrthle S Hoel, Nurse, 004771121943, myrthle.sletvag.hoel@helse-mr.no
Frank-David Øhrn, MD, PhD, 004771117869, frank-david.ohrn@helse-mr.no
Volda Hospital
Volda, Møre and Romsdal
Erik Ostnes, MD, 004770105000, erik.ostnes@helse-mr.no
Magne M Røkkum, MD, 004770105000, Magne.Martin.Rokkum@helse-mr.no
About this study
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.
- Conditions
- Knee Osteoarthritis, Hip Osteoarthritis, Osteonecrosis, Osteoarthritis
- Being tested
- Total Hip Arthroplasty, Total Knee Arthroplasty, Unicondylar knee artrhoplasty
- 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
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Osteonecrosis, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyProcedure or surgery
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.
Total Knee ArthroplastyProcedure or surgery
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.
Unicondylar knee artrhoplastyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Total Hip Arthroplasty | Eligable patients for daycase surgery with hip osteoarthritis, osteonecrosis or other indication for total hip arthroplasty Receives: Procedure: Total Hip Arthroplasty | |
| Total Knee Arthroplasty | Eligable patients for daycase surgery with knee osteoarthritis, osteonecrosis or other indication for total knee arthroplasty Receives: Procedure: Total Knee Arthroplasty | |
| Unicondylar Knee Arthroplasty | Eligable patients for daycase surgery with knee osteoarthritis, osteonecrosis or other indication for unicondylar knee arthroplasty Receives: Procedure: Unicondylar knee artrhoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (11)
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.
Measured: Preoperative and 3 months postoperative
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
Measured: Preoperative and 3 months postoperative
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.
Measured: Preoperative and 3 months postoperative
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.
Measured: Baseline
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.
Measured: Preoperative and 3 months postoperative
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.
Measured: Baseline, Postoperative day 1, 3 and 7, 1 month and 3 months
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.
Measured: Prepoerative, before discharge after surgery, postoperative day 1-7, 1 and 3 months postoperative.
Proportion of resubmission
Proportion of patients who are subject to resubmission of any reason after surgery
Measured: postoperative day 1, day 7, 1 and 3 months
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.
Measured: Up to 3 months after surgery
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.
Measured: Preoperative and 3 months postoperative
Claudien-Dindo classification
Grading of the potential complications from 1 to 5.
Measured: peroperativ, 1 day postoperative, 7 days postoperative, 30 days postoperative and 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion31 Jul 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Helse Møre og Romsdal HF
- Sponsor type
- Other government
- Collaborators
- Oslo University Hospital, University of Oslo, Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Frank-David Øhrn, MD, PhD, Study chair, Nordmøre and Romsdal Hospital, Møre and Romsdal Hospital TrustFrank-David Øhrn, MD, PhD, Principal investigator, Nordmøre and Romsdal Hospital, Møre and Romsdal Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834034
- Sponsor's protocol ID
- 982890
- Acronym
- DART
- Status last verified
- Sep 2026
- First submitted
- 11 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.