Condition category
Musculoskeletal Diseases
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
22/07/2013
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

Dr Karen Barker

ORCID ID

Contact details

Windmill Road
Oxford
OX3 7LD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4985

Study information

Scientific title

Evaluation of a specific physiotherapy programme following resurfacing arthroplasty - is it more effective at improving function and muscle strength than standard rehabilitation?

Acronym

Rehab after RHA

Study hypothesis

To evaluate the effectiveness of a post-operative physiotherapy programme specifically designed to the needs of patients with hip resurfacing arthroplasty (RHA) compared to standard protocols based upon total hip arthroplasty (THA) rehabilitation guidelines.

Hypothesis:
A specific rehabilitation programme following hip resurfacing arthroplasty (RHA) will improve functional outcome assessed at one year post surgery.

Design:
Single blind prospective randomised clinical trial.

Ethics approval

Oxfordshire Research Ethics Committee (REC) B approved in August 2006 with an amendment in April 2008 (ref: PB-PG-0407-13216)

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal

Intervention

A specific rehabilitation programme focussing on range of hip flexion, hip extension strength and single stance higher-demand activities. The content of the rehabilitation programme has been developed following appraisal of the existing literature, focus groups with arthroplasty practitioners and by involvement of a group of patients/service users.

Data will be analysed on an intention to treat basis.

Follow up length: 12 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Oxford Hip Score at 6 and 12 months

Secondary outcome measures

Mesaured at 6 weeks, 4 months, 12 months:
1. Timed sit-to-stand
2. Timed Single leg stand
3. Maximal isometric torque strength for flexion

Overall trial start date

01/09/2008

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

All patients (either sex, no age limit) who are listed to receive a hip resurfacing arthroplasty will be eligible to take part in the study.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

Planned Sample Size: 50

Participant exclusion criteria

1. Undergoing bilateral arthroplasty
2. Minimally invasive surgery
3. Further lower limb joint surgery is planned within the next twelve months
4. Unable to provide informed consent

Recruitment start date

01/09/2008

Recruitment end date

31/12/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Windmill Road
Oxford
OX3 7LD
United Kingdom

Sponsor information

Organisation

Nuffield Orthopaedic Centre NHS Trust (UK)

Sponsor details

Windmill Rd
Headington
Oxford
OX3 7LD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.noc.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23576032

Publication citations

  1. Results

    Barker KL, Newman MA, Hughes T, Sackley C, Pandit H, Kiran A, Murray DW, Recovery of function following hip resurfacing arthroplasty: a randomized controlled trial comparing an accelerated versus standard physiotherapy rehabilitation programme., Clin Rehabil, 2013, 27, 9, 771-784, doi: 10.1177/0269215513478437.

Additional files

Editorial Notes