NCT01849445

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
334

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 8, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2017

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

4 years

First QC Date

May 3, 2013

Last Update Submit

April 18, 2019

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Patient satisfaction

    52 weeks post-operation

  • Knee function

    week 8 and week 14

  • Cost effectiveness

    52 weeks post

Study Arms (2)

Intensive physiotherapy

ACTIVE COMPARATOR

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

Home physiotherapy excercises

ACTIVE COMPARATOR

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

Other: Home physiotherapy exercises

Interventions

Intensive physiotherapyPROCEDURE

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.

Intensive physiotherapy
Home physiotherapy exercisesOTHER

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

Home physiotherapy excercises

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

NHS Grampian

Aberdeen, AB24 2ZN, United Kingdom

Location

Doncaster Royal Infirmary

Doncaster, United Kingdom

Location

NHS Lothian

Edinburgh, EH16 4SA, United Kingdom

Location

Oxford University Hospitals NHS Trust

Oxford, OX3 7HE, United Kingdom

Location

Kim Brown

Portsmouth, PO3 6AD, United Kingdom

Location

Weston Super Mare

Weston-super-Mare, United Kingdom

Location

Related Publications (2)

  • Hamilton DF, Beard DJ, Barker KL, Macfarlane GJ, Tuck CE, Stoddart A, Wilton T, Hutchinson JD, Murray GD, Simpson AHRW; TRIO investigators. Targeting rehabilitation to improve outcomes after total knee arthroplasty in patients at risk of poor outcomes: randomised controlled trial. BMJ. 2020 Oct 13;371:m3576. doi: 10.1136/bmj.m3576.

    PMID: 33051212DERIVED

  • Simpson AH, Hamilton DF, Beard DJ, Barker KL, Wilton T, Hutchison JD, Tuck C, Stoddard A, Macfarlane GJ, Murray GD. Targeted rehabilitation to improve outcome after total knee replacement (TRIO): study protocol for a randomised controlled trial. Trials. 2014 Feb 1;15:44. doi: 10.1186/1745-6215-15-44.

    PMID: 24484541DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Hamish Simpson

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2013

First Posted

May 8, 2013

Study Start

September 1, 2013

Primary Completion

August 25, 2017

Study Completion

November 30, 2017

Last Updated

April 19, 2019

Record last verified: 2019-04

Locations

GB(6)