Targeted Rehabilitation to Improve Outcome After Knee Replacement- A Physiotherapy Study

Osteoarthritis of the Knee Clinical Trial

— TRIO-Physio  

Official title:

Targeted Rehabilitation to Improve Outcome After Knee Replacement- A Physiotherapy Study (TRIO-Physio)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01849445
• Other study ID #: Arthritis Research UK 20100
• Secondary ID: 13\SS\0051
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: November 30, 2017

Study information

• Verified date: April 2019
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The study is a randomised controlled trial comparing the effect of intensive physiotherapy compared to current standard of care therapy, targeted to patients performing poorly at 6 weeks following total knee replacement.

All patients will be made aware of the study pre-operatively at the recruiting centres. Prior to surgery they will complete the routine pre-operative outcome assessment questionnaires (Oxford Knee Score and EQ-5D) as part of the national PROMS program and then undergo the local standard total knee replacement and immediate post-operative care pathway.

All patients will be routinely reviewed 6 weeks post-operatively by the usual clinical teams. At this review the Oxford Knee Score will again be assessed. Those patients who report a score of 26 or less (on the 0-48 OKS scoring system), which is defined as poor by the Kalairajah classification (Kalairajah, 2005), will be approached to consent. If consent is given and the patient is eligible to enter the trial, randomisation into one of the following groups will occur: to standard care (encompassing a one off physiotherapy review, 6 weeks of home exercise prescription and final review) or to an interventional arm, where 18 sessions of structured physiotherapy will be administered over a 6 week period, where 6 of these sessions will be 'contact sessions' performed under the supervision of the physiotherapist.

All trial participants will be reviewed immediately post intervention (i.e. at 14 weeks post operation) and then by postal questionnaire at 26 and 52 weeks post-operation.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Procedure:
• Intensive physiotherapy
Participants will visit hospital for physiotherapy sessions once a week for 6 weeks in addition to completing prescribed exercises twice a week at home on their own.

Other:
• Home physiotherapy exercises
Patients will be asked to complete prescribed exercises at home on their own 3 times a week for 6 weeks.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	Arthritis Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

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