Does Rehabilitation After Total Knee Arthroplasty Work? - Feasibility Trial
DRAW-TKA-Fea
Feasibility of a Randomized Trial Comparing Exercise-based Rehabilitation With Non-exercise-based Recovery After Total Knee Arthroplasty; DRAW-TKA Hybrid 1 Feasibility Trial
1 other identifier
interventional
25
1 country
2
Brief Summary
The aim of this feasibility trial is to investigate the feasibility of a trial intervention for a population of patients after total knee replacement for osteoarthritis. This study follows a hybrid type 1 design where the primary focus is on the feasibility of the intervention, and the secondary focus is on gaining a better understanding of context and acceptability. The main questions it aims to answer are:
- Recruitment (Process/Resources): Are patients willing to engage, and stay, in the trial (estimated by inclusion-rate, participant retention, etc.) and what reasons do patients give for not wishing to enroll or later dropping out of the trial? (inquired face-to-face, during enrolment).
- Harms (Scientific): Does the non-exercise intervention appear "safe" (i.e. not harmful) for the patients? (estimated by for instance: adverse events, reasons for dropouts and sense of security).
- Trial procedure feasibility (Management/Scientific): How well does recruitment and trial procedures work at trial sites? (estimated through feedback from site personnel).
- Participant (patient) experienced acceptability of their assigned intervention: An interview-based follow-up using the Theoretical Framework of Acceptability. Participants will be randomized to one of two interventions, at discharge from the hospital, following knee replacement, which are being tested for feasibility:
- "Usual-care" - referral to municipal (free-of-charge) physiotherapy (commonly 6-8 weeks of therapeutic exercise).
- "Return to everyday life" - no referral to municipal physiotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2023
CompletedFirst Posted
Study publicly available on registry
July 7, 2023
CompletedStudy Start
First participant enrolled
August 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2024
CompletedJuly 9, 2025
February 1, 2025
10 months
June 26, 2023
July 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility Trial - Primary outcome is an evaluation of trial feasibility:
The following criteria are considered most important to evaluate feasibility: * No more than 20% of participants may drop out of the "return-to-everyday-life" group because they change their mind and wish to receive exercise-based rehabilitation instead (wish to cross over) * At least 10% of the patients who receive full trial information, are subsequently enrolled in the trial * At least 85% of enrolled participants complete the primary outcome assessment at 12 weeks * At least one participant (on average) must be included at each site, each week The criteria, and and all other outcomes, form the basis of a trial group discussion with the intent of agreeing on one of the following interpretations (large-scale trial feasibility): 1\) Main study not feasible - stop main study, 2) Feasible with modification - continue main study with modifications, 3) Feasible without modification - no modifications but close monitoring, 4) Feasible as is - continue without modifications.
Full duration of feasibility trial from enrollment to last follow-up at 12 weeks from surgery
Recruitment (Process and resources):
* Enrolment rate - how many of the eligible patients (given full trial information) end up as participants (signed informed consent) * Barriers to participation - why do patients decline to enroll (enquired when they decline participation when given full trial information) * Retention rate - how many participants complete the 12-week follow-up * Barriers to retention - why do participants decide to discontinue participation in the trial * Eligibility criteria - how many participants drop out after enrolment * Trial measures - how many participants have blank/incomplete/complete tests and questionnaires
Full duration of feasibility trial from enrollment to last follow-up at 12 weeks from surgery
Secondary Outcomes (4)
Harms (Scientific)
Full duration of feasibility trial from enrollment to last follow-up at 12 weeks from surgery
Trial personnel feasibility (Management/Scientific)
Full duration of feasibility trial from enrollment to last follow-up at 12 weeks from surgery
Participant symptom guide follow-up
Full duration of feasibility trial from enrollment to last follow-up at 12 weeks from surgery
Participant (patient) experiences and experienced acceptability; of their allocated intervention
Interviews will be conducted after participants complete the 12 week follow-up
Study Arms (2)
Usual Care
ACTIVE COMPARATORReferral to municipal rehabilitation after TKA
Return to Everyday Life
OTHERNo referral to municipal rehabilitation after TKA
Interventions
The patients in this group follow prescribed (by the orthopedic surgeon) "usual care" municipal exercise-based rehabilitation. The content of the rehabilitation is planned in collaboration between the patient and the physical therapist, based on the offered municipal treatment options (which varies between municipalities) and patient preferences (i.e., home-based exercise, outpatient exercise, group-based exercise, or a combination thereof). The contents of the municipal services offered will be described in detail in the trial report. A prescribed therapeutic rehabilitation exercise plan could for instance be a 6-week combined home-exercise (1-2 times/week) and group-exercise (1 time/week) intervention, followed by encouragement to continue self-administered home exercise after the 6 weeks.
The patients in this group return to their desired pre-surgical activities, at their own speed, when they feel that they are ready for it. They are not prescribed any exercise-based rehabilitation (usual care) by their orthopedic surgeon. This effectively means they will not receive a therapeutic progressive exercise plan; designed and prescribed to restore previous function or reducing pain or disability caused by injury, disease, or surgery - typically referred to as "exercise therapy" or "therapeutic exercise".
Participants in both groups receive a recovery-guide pamphlet at discharge, containing the following information: 1) Recommendations to follow DHA/WHO guidelines for physical activity, 2) Figures and tables describing common post-operative symptoms (symptom guide), and when to react (when the symptoms may require attention from a health-professional), 3) What to expect from the post-surgical period in relation to activities of daily living, 4) Common short- and long-term complications to total knee arthroplasty and 5) Trial-participant and ethics-committee information documents. Parts 2-4 are usual clinical practice, with slight variations in descriptions between sites. After surgery, participants in both groups are encouraged to resume their desired pre-surgical activities when they feel they are able (within the limits given from the orthopedic wards).
Eligibility Criteria
You may qualify if:
- Over 18 years of age
- Residing in one of fourteen collaboration municipalities
- Referral to primary total knee arthroplasty for osteoarthritis
You may not qualify if:
- Insufficient danish skills (read/write/speak) to understand questionnaires and outcomes
- Inability to provide informed consent
- Severe surgical sequelae (i.e. requiring revision surgery, joint mobilization under anaestesia, or joint infection)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Copenhagen University Hospital, Hvidovrelead
- Danske Fysioterapeutercollaborator
- Sygekassernes Helsefondcollaborator
- University of Copenhagencollaborator
- The Danish Rheumatism Associationcollaborator
- Tværspuljencollaborator
Study Sites (2)
Copenhagen University Hospital Hvidovre
Hvidovre, 2650, Denmark
Næstved Sygehus
Næstved, 4700, Denmark
Related Publications (1)
Gronfeldt BM, Skou ST, Kirk JW, Troelsen A, Bandholm T; DRAW-TKA collaborator group. Feasibility of a randomized trial comparing exercise-based rehabilitation to no exercise-based rehabilitation after total knee arthroplasty: DRAW-TKA hybrid 1 RCT. Osteoarthr Cartil Open. 2025 Nov 21;8(1):100708. doi: 10.1016/j.ocarto.2025.100708. eCollection 2026 Mar.
PMID: 41431738DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Investigator and Outcomes Assessor are blinded to participant group allocation. Further, the personnel administering the intervention after discharge from the surgical ward (Care Provider) is masked.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Fellow
Study Record Dates
First Submitted
June 26, 2023
First Posted
July 7, 2023
Study Start
August 22, 2023
Primary Completion
June 10, 2024
Study Completion
September 10, 2024
Last Updated
July 9, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share
There is no plan to share IPD.