Does Rehabilitation After Total Knee Arthroplasty Work? - Feasibility Trial

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:

1. "Usual-care" - referral to municipal (free-of-charge) physiotherapy (commonly 6-8 weeks of therapeutic exercise).
2. "Return to everyday life" - no referral to municipal physiotherapy.

Participants in both groups are encouraged to follow WHO guidelines of physical activity, to the degree that their post-surgical symptoms allow (within their orthopedic surgeon's recommendations/limitations). All participants are given a "symptom guide", meaning a folder containing information on what to expect, and when and what to react to, during their recovery after the knee-replacement.

For clarity it should be mentioned, that the quantitative and qualitative data-outputs will be reported separately for improved clarity (the study is not a mixed methods design).

Conditions

• Osteoarthritis, Knee

Interventions

OTHER

Usual care - Municipal exercise-based rehabilitation

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.

OTHER

Return to Everyday life

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".

BEHAVIORAL

Symptom guide and encouragement to follow DHA/WHO recommendations for physical activity

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).

Sponsors & Collaborators

• Danske Fysioterapeuter

  collaborator OTHER

• Sygekassernes Helsefond

  collaborator OTHER

• University of Copenhagen

  collaborator OTHER

• The Danish Rheumatism Association

  collaborator OTHER

• Tværspuljen

  collaborator UNKNOWN

• Copenhagen University Hospital, Hvidovre

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-22

Primary Completion

2024-06-10

Completion

2024-09-10

Countries

• Denmark

Study Locations