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
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
-
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.