Targeted Rehabilitation to Improve Outcome After Knee Replacement- A Physiotherapy Study (TRIO-Physio)
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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-
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Aberdeen, Verenigd Koninkrijk, AB24 2ZN
- NHS Grampian
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Doncaster, Verenigd Koninkrijk
- Doncaster Royal Infirmary
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Edinburgh, Verenigd Koninkrijk, EH16 4SA
- NHS Lothian
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Oxford, Verenigd Koninkrijk, OX3 7HE
- Oxford University Hospitals NHS Trust
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Portsmouth, Verenigd Koninkrijk, PO3 6AD
- Kim Brown
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Weston Super Mare, Verenigd Koninkrijk
- Weston Super Mare
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-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: 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.
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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.
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Actieve vergelijker: Home physiotherapy excercises
Patients will be asked to complete prescribed exercises at home on their own 3 times a week for 6 weeks.
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Patients will be asked to complete prescribed exercises at home on their own 3 times a week for 6 weeks.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Oxford Knee Score
Tijdsspanne: 52 weeks post-operation
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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.
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52 weeks post-operation
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Patient satisfaction
Tijdsspanne: 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:
(Possible answers: excellently, very well, well, fairly, poorly) |
52 weeks post-operation
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|
Knee function
Tijdsspanne: week 8 and week 14
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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).
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week 8 and week 14
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Cost effectiveness
Tijdsspanne: 52 weeks post
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To evaluate the cost effectiveness of enhanced targeted physiotherapy.
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52 weeks post
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Hamish Simpson, University of Edinburgh
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Arthritis Research UK 20100
- 13\SS\0051 (Andere identificatie: South East Scotland REC 01)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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