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

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ClinicalTrials.gov Identifier: NCT01849445
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : April 19, 2019
Sponsor:
Collaborator:
Arthritis Research UK
Information provided by (Responsible Party):
University of Edinburgh

Brief 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.


Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Procedure: Intensive physiotherapy Other: Home physiotherapy exercises Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeted Rehabilitation to Improve Outcome After Knee Replacement- A Physiotherapy Study (TRIO-Physio)
Actual Study Start Date : September 2013
Actual Primary Completion Date : August 25, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)


  2. 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).

  3. Cost effectiveness [ Time Frame: 52 weeks post ]
    To evaluate the cost effectiveness of enhanced targeted physiotherapy.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849445


Locations
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United Kingdom
NHS Grampian
Aberdeen, United Kingdom, AB24 2ZN
Doncaster Royal Infirmary
Doncaster, United Kingdom
NHS Lothian
Edinburgh, United Kingdom, EH16 4SA
Oxford University Hospitals NHS Trust
Oxford, United Kingdom, OX3 7HE
Kim Brown
Portsmouth, United Kingdom, PO3 6AD
Weston Super Mare
Weston Super Mare, United Kingdom
Sponsors and Collaborators
University of Edinburgh
Arthritis Research UK
Investigators
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Principal Investigator: Hamish Simpson University of Edinburgh

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01849445     History of Changes
Other Study ID Numbers: Arthritis Research UK 20100
13\SS\0051 ( Other Identifier: South East Scotland REC 01 )
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases