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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Aberdeen, Storbritannia, AB24 2ZN
- NHS Grampian
-
Doncaster, Storbritannia
- Doncaster Royal Infirmary
-
Edinburgh, Storbritannia, EH16 4SA
- NHS Lothian
-
Oxford, Storbritannia, OX3 7HE
- Oxford University Hospitals NHS Trust
-
Portsmouth, Storbritannia, PO3 6AD
- Kim Brown
-
Weston Super Mare, Storbritannia
- Weston Super Mare
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
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.
|
|
Aktiv komparator: Home physiotherapy excercises
Patients will be asked to complete prescribed exercises at home on their own 3 times a week for 6 weeks.
|
Patients will be asked to complete prescribed exercises at home on their own 3 times a week for 6 weeks.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Oxford Knee Score
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient satisfaction
Tidsramme: 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
|
|
Knee function
Tidsramme: 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
Tidsramme: 52 weeks post
|
To evaluate the cost effectiveness of enhanced targeted physiotherapy.
|
52 weeks post
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Hamish Simpson, University of Edinburgh
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Arthritis Research UK 20100
- 13\SS\0051 (Annen identifikator: South East Scotland REC 01)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .