Osteoarthritis of the Knee Clinical Trial
— TRIO-PhysioOfficial title:
Targeted Rehabilitation to Improve Outcome After Knee Replacement- A Physiotherapy Study (TRIO-Physio)
Verified date | April 2019 |
Source | University of Edinburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The TRIO-physio study is looking at how well patients with osteoarthritis recover after knee
replacement surgery (also known as Total Knee Arthroplasty (TKA)). Currently around 20% of
patients are not satisfied after TKA. This project will look to find out if the research team
can identify patients who will not recover well at an earlier stage, so that these patients
can be helped sooner.
The study will try to determine if doing intense physiotherapy with patients who are not
doing well at the first review (6 weeks after their operation) can improve how well they have
recovered at one year.
Status | Completed |
Enrollment | 334 |
Est. completion date | November 30, 2017 |
Est. primary completion date | August 25, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - Undergoing primary total knee arthroplasty for osteoarthritis. - Defined poor outcome (Oxford Knee Score less than or equal to 26) at first post-op review (6 weeks). - Patients are able to consent and willing to comply with the study protocol Exclusion Criteria: - Patients undergoing revision knee arthroplasty or fully constrained knee arthroplasty - Knee replacement for a diagnosis other than osteoarthritis - Patients unable to attend the study physiotherapy intervention centre - Procedures done purely for pain relief (such as for patients with no walking capacity) - Patients already receiving ongoing structured post-operative exercise rehabilitation |
Country | Name | City | State |
---|---|---|---|
United Kingdom | NHS Grampian | Aberdeen | |
United Kingdom | Doncaster Royal Infirmary | Doncaster | |
United Kingdom | NHS Lothian | Edinburgh | |
United Kingdom | Oxford University Hospitals NHS Trust | Oxford | |
United Kingdom | Kim Brown | Portsmouth | |
United Kingdom | Weston Super Mare | Weston Super Mare |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh | Arthritis Research UK |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oxford Knee Score | Primary analysis will be 52 week outcome (Oxford Knee Score) in the enhanced physiotherapy intervention group compared to the current standard of care physiotherapy treatment group. | 52 weeks post-operation | |
Secondary | Patient satisfaction | Assess patient satisfaction with knee arthroplasty. Assessed with a specific patient satisfaction question: Are you satisfied with your knee replacement? (Possible responses: very satisfied, satisfied, dissatisfied, very dissatisfied) Specific satisfaction with pain relief and functional ability will also be assessed. 4 additional sub-questions relating to facets of satisfaction: "How well did the surgery relieve the pain in your affected joint?" "How well did the surgery increase your ability to perform regular activities?" "How well did the surgery allow you to perform heavy work or sport activities?" "How well did the surgery meet your expectations?" (Possible answers: excellently, very well, well, fairly, poorly) |
52 weeks post-operation | |
Secondary | Knee function | Assess the actual physical function of the patient as a result of the differing physiotherapy interventions. Timed-get-up-and-go-test, assessed prior to (8-weeks post op) and following 6 week physiotherapy protocol (14 weeks post-op). | week 8 and week 14 | |
Secondary | Cost effectiveness | To evaluate the cost effectiveness of enhanced targeted physiotherapy. | 52 weeks post |
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