Comparison of post-discharge physiotherapy versus usual care following total knee replacement: a randomised clinical trial
| ISRCTN | ISRCTN07624314 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07624314 |
| Secondary identifying numbers | N0176127673 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 10/09/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Catherine Minns Lowe
Scientific
Scientific
Physiotherapy Research Unit
The Nuffield Orthoapedic Centre NHS Trust
Windmill Road
Oxford
OX3 7LD
United Kingdom
| Phone | +44 (0)1865 737526 |
|---|---|
| catherine.minnslowe@noc.anglox.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Please note that as of 02/07/2008 this record was extensively updated due to service structure changes. All updates can be seen under the relevant field, under the update date of 02/07/2008. The previous title of the trial was Is the intervention of primary care physiotherapy effective in improving mobility and function after elective joint surgery in a Diagnostic and Treatment Centre? The current target number of participants has also been changed to 107 patients; the previous target number of participants was 250 patients. Current hypothesis as of 02/07/2008: The study will evaluate the intervention of an innovative physiotherapist for patients undergoing elective primary total knee arthroplasty for osteoarthritis; the ability to improve mobility and enhance functional activity compared with standard care. The study will also document the effect of the intervention on health resource utilisation and include an economic evaluation. Previous hypothesis: The study will evaluate the intervention of a community physiotherapist for patients undergoing arthroplasty specifically; the ability to improve mobility and enhance functional activity compared with standard care. The study will also document the effect of Diagnostic and Treatment Centre surgery on primary care resource use and include an economic evaluation. |
| Ethics approval(s) | Ethics approval received from The Oxford Local Research Ethics Committee on the 20th August 2003 (AQREC No: A03.018). Trial amendments were approved via substantive amendment (amendment 1 date = 23/05/2005, amendment 2 date = 18/10/2006). Date of approval runs from 20th August 2003 until 30th April 2009. |
| Health condition(s) or problem(s) studied | Surgery: post-operative care |
| Intervention | Current interventions as of 02/07/2008: The intervention group patients received two physiotherapy home visits. The first visit took place within two weeks of discharge and the second visit was 6 - 8 weeks post-operatively. The intervention consisted of these two home visits. During each visit the physiotherapist assessed the participants function and progressed each participants rehabilitation programme as appropriate. Objective reassessment of range of movement, muscle strength and observation of functional activities (including transfers, gait, posture and balance) occurred to enable this progression of treatment. Gait re-education and progression/removal of walking aids, task specific training and a daily home exercise programme were included. The exercises were defined following a systematic review. The control arm received the usual care currently provided by the hospital with no additional input. Usual care includes no routine physiotherapy organised post discharge. All trial participants (both arms) received a knee advice booklet presently used by the hospital to standardise the advice provided. The advice and exercises contained in these booklets are essentially similar to those used as controls in previous trials. The exercises include non weight bearing exercises to regain range of movement plus isometric strengthening exercises and several exercises in weightbearing Previous interventions: Community physiotherapist versus standard care. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Current primary outcome measures as of 02/07/2008: Oxford Knee Score. Trial patients underwent reassessment, using all outcome measures, at three and twelve months post-operatively by a physiotherapist blind to trial arm allocation. Patients were also followed up at six months post-operatively by postal questionnaire containing Oxford Knee score, the Knee injury and Osteoarthritis Outcome Score (KOOS) and the EuroQol. Previous primary outcome measures: Changes in Oxford Hip and Knee and Iowa Level of Assistance Scores, timed sit-to-stand, EuroQol and resource use diaries. |
| Secondary outcome measures | Added as of 02/07/2008: 1. The Knee injury and Osteoarthritis Outcome Score (KOOS) 2. The timed sit-to-stand test 3. The timed walk test 4. The Leg extensor press 5. Joint range of motion 6. The EuroQol questionnaire (EQ-5D) 7. Patient diaries to collect heath resource utilisation Trial patients underwent reassessment, using all outcome measures, at three and twelve months post-operatively by a physiotherapist blind to trial arm allocation. Patients were also followed up at six months post-operatively by postal questionnaire containing Oxford Knee score, the Knee injury and Osteoarthritis Outcome Score (KOOS) and the EuroQol. |
| Overall study start date | 20/08/2003 |
| Completion date | 01/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 107 patients (recruitment phases completed) |
| Key inclusion criteria | Added as of 02/07/2008: Age range and gender was unspecified; all patients undergoing an elective primary total knee arthroplasty for osteoarthritis and who reside within the community of Oxfordshire were eligible. |
| Key exclusion criteria | Added as of 02/07/2008: 1. Patients undergoing bilateral arthroplasty 2. Minimally invasive surgery and metal-to-metal implants 3. Patients where further joint surgery is planned within the next twelve months 4. Patients with inflammatory arthritis 5. Patients whose existing co-morbities prevent them from participating in the proposed treatment intervention 6. Patients who are unable to provide informed consent |
| Date of first enrolment | 20/08/2003 |
| Date of final enrolment | 01/04/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Physiotherapy Research Unit
Oxford
OX3 7LD
United Kingdom
OX3 7LD
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Oxford Radcliffe Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2012 | Yes | No |
