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

April 18, 2019 updated by: University of Edinburgh

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

334

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Aberdeen, United Kingdom, AB24 2ZN
        • NHS Grampian
      • Doncaster, United Kingdom
        • Doncaster Royal Infirmary
      • Edinburgh, United Kingdom, EH16 4SA
        • NHS Lothian
      • Oxford, United Kingdom, OX3 7HE
        • Oxford University Hospitals NHS Trust
      • Portsmouth, United Kingdom, PO3 6AD
        • Kim Brown
      • Weston Super Mare, United Kingdom
        • Weston Super Mare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Active Comparator: Home physiotherapy excercises
Patients will be asked to complete prescribed exercises at home on their own 3 times a week for 6 weeks.
Other: Home physiotherapy exercises
Patients will be asked to complete prescribed exercises at home on their own 3 times a week for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxford Knee Score
Time Frame: 52 weeks post-operation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 52 weeks post-operation

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:

  1. "How well did the surgery relieve the pain in your affected joint?"
  2. "How well did the surgery increase your ability to perform regular activities?"
  3. "How well did the surgery allow you to perform heavy work or sport activities?"
  4. "How well did the surgery meet your expectations?"

(Possible answers: excellently, very well, well, fairly, poorly)
52 weeks post-operation
Knee function
Time Frame: week 8 and week 14
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
Cost effectiveness
Time Frame: 52 weeks post
To evaluate the cost effectiveness of enhanced targeted physiotherapy.
52 weeks post

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

Arthritis Research UK

Investigators

  • Principal Investigator: Hamish Simpson, University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

August 25, 2017

Study Completion (Actual)

November 30, 2017

Study Registration Dates

First Submitted

May 3, 2013

First Submitted That Met QC Criteria

May 3, 2013

First Posted (Estimate)

May 8, 2013

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 18, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Arthritis Research UK 20100
  • 13\SS\0051 (Other Identifier: South East Scotland REC 01)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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