Ignite Creation Date:
2024-05-06 @ 1:34 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01849445
Status:
COMPLETED
Last Update Posted:
2019-04-19
First Post:
2013-05-03
Brief Title:
Targeted Rehabilitation to Improve Outcome After Knee Replacement- A Physiotherapy Study
Sponsor:
University of Edinburgh
Organization:
University of Edinburgh
Study Overview
Official Title:
Targeted Rehabilitation to Improve Outcome After Knee Replacement- A Physiotherapy Study TRIO-Physio
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIO-Physio
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
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
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 ie at 14 weeks post operation and then by postal questionnaire at 26 and 52 weeks post-operation
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 ie at 14 weeks post operation and then by postal questionnaire at 26 and 52 weeks post-operation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 13SS0051 | OTHER | South East Scotland REC 01 | None |