Daycase Hip and Knee Arthroplasty in Møre and Romsdal Trial
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorHelse Møre og Romsdal HF
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients 18-80 years old scheduled for primary TKA, UKA or THA
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Total Hip Arthroplasty
Procedure/SurgeryTotal 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 Arthroplasty
Procedure/SurgeryTotal 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 artrhoplasty
Procedure/SurgeryUniconcylar 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.
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: Total Hip Arthroplasty1 intervention
Group B: Total Knee Arthroplasty1 intervention
Group C: Unicondylar Knee Arthroplasty1 intervention
Trial outcomes
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 postoperative2
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 postoperative3
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 postoperative4
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
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Helse Møre og Romsdal HF
Lead sponsor
Oslo University Hospital
Collaborator
University of Oslo
Collaborator
Norwegian University of Science and Technology
Collaborator
Source ClinicalTrials.gov
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