Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
10/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Catherine Minns Lowe

ORCID ID

Contact details

Physiotherapy Research Unit
The Nuffield Orthoapedic Centre NHS Trust
Windmill Road
Oxford
OX3 7LD
United Kingdom
+44 (0)1865 737526
catherine.minnslowe@noc.anglox.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0176127673

Study information

Scientific title

Acronym

Study hypothesis

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

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.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

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 participant’s function and progressed each participant’s 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

20/08/2003

Overall trial end date

01/04/2009

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

107 patients (recruitment phases completed)

Participant 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

Recruitment start date

20/08/2003

Recruitment end date

01/04/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Physiotherapy Research Unit
Oxford
OX3 7LD
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Oxford Radcliffe Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22180446

Publication citations

  1. Results

    Minns Lowe CJ, Barker KL, Holder R, Sackley CM, Comparison of postdischarge physiotherapy versus usual care following primary total knee arthroplasty for osteoarthritis: an exploratory pilot randomized clinical trial., Clin Rehabil, 2012, 26, 7, 629-641, doi: 10.1177/0269215511427749.

Additional files

Editorial Notes