Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000282785
Ethics application status
Approved
Date submitted
5/03/2013
Date registered
8/03/2013
Date last updated
3/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of a physiotherapy program for individuals following arthroscopic surgery for symptomatic femoroacetabular impingement: a randomised controlled trial
Scientific title
To evaluate the effects of a physiotherapist-supervised rehabilitation program compared to no formal rehabilitation program on self-reported outcomes in people following hip arthroscopy for symptomatic femoroacetabular impingement.
Secondary ID [1] 282075 0
Nil
Universal Trial Number (UTN)
U1111-1140-2259
Trial acronym
FAIR (FemoroAcetabular Impingement Rehabilitation) Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptomatic Femoroacetabular impingement 288565 0
Condition category
Condition code
Musculoskeletal 288897 288897 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 288898 288898 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Physiotherapist-supervised rehabilitation group. Participants in the physiotherapy group will receive standard post-surgical care in addition to attending a project physiotherapist for seven treatment sessions. This will include one pre-operative visit approximately 30 minutes long and within two weeks prior to surgery. There will be six post-operative visits over 12 weeks, commencing approximately two weeks post-operatively. Each session will be an individual appointment of approximately 30 minutes. Participants in the physiotherapy group will receive a home exercise program, education and advice regarding activity, manual therapy and an unsupervised gym program.
Intervention code [1] 286673 0
Rehabilitation
Intervention code [2] 286695 0
Treatment: Other
Comparator / control treatment
No physiotherapist-supervised rehabilitation group: The control group will receive standard post-surgical care. Participants in the control group will not receive the formal rehabilitation program. Participants will gradually increase their physical activity levels and return to exercise and sport based on information provided by their surgeon.
Control group
Active

Outcomes
Primary outcome [1] 289028 0
The international Hip Outcome Tool (iHOT-33), which is a self administered tool that measures health-related quality of life in young people with hip disorders
Timepoint [1] 289028 0
Baseline and 14 weeks post-surgery
Primary outcome [2] 289029 0
The Sport subscale of the Hip Outcome Scale (HOS), which is a self-administered questionnaire designed to assess function in sport activities in patients undergoing hip arthroscopy
Timepoint [2] 289029 0
Baseline and 14 weeks post-surgery
Secondary outcome [1] 301598 0
The international Hip Outcome Tool (iHOT-33), which is a self administered tool that measures health-related quality of life in young people with hip disorders
Timepoint [1] 301598 0
24 weeks post-surgery
Secondary outcome [2] 301599 0
The Sport subscale of the Hip Outcome Scale (HOS), which is a self-administered questionnaire designed to assess function in sport activities in patients undergoing hip arthroscopy
Timepoint [2] 301599 0
24 week after surgery
Secondary outcome [3] 301600 0
The Activities of Daily Living subscale of the Hip Outcome Scale (HOS), which is a self-administered questionnaire designed to assess function in activities of daily living in patients undergoing hip arthroscopy
Timepoint [3] 301600 0
Baseline, 14 weeks and 24 weeks post-surgery
Secondary outcome [4] 301601 0
Copenhagen Hip and Groin Outcome Score (HAGOS), which is a patient-reported questionnaire specifically developed for young to middle-aged, physically active individuals with hip and groin pain. It consists of 37 items in six separate subscales relating to the past week assessing Pain, Symptoms, Physical function in daily living , Physical function in Sport and Recreation, Participation in Physical Activities and hip and/or groin-related Quality of Life.
Timepoint [4] 301601 0
Baseline, 14 weeks and 24 weeks post-surgery
Secondary outcome [5] 301602 0
Participant-rated global rating of change - participants will rate their perceived overall change compared to baseline on a seven-point ordinal scale
Timepoint [5] 301602 0
14 and 24 weeks post-surgery
Secondary outcome [6] 301603 0
Adherence – this will be assessed in the physiotherapist-supervised rehabilitation group by the number of physiotherapy sessions attended and by adherence to the rehabilitation program as recorded in a log book by the participant.
Timepoint [6] 301603 0
Weekly throughout the physiotherapy program
Secondary outcome [7] 301604 0
Participants’ level of physical activity and sports participation will be measured by a modified Tegner Activity Scale and the Heidelberg Sports Activity Score
Timepoint [7] 301604 0
baseline, 14 and 24 weeks post-surgery
Secondary outcome [8] 301605 0
Hip pathology and surgical procedure details
Timepoint [8] 301605 0
At the time of surgery

Eligibility
Key inclusion criteria
Participants will be eligible if they are aged 16-35 years, have had hip/groin symptoms for at least 3 months, have been diagnosed with FAI by an orthopaedic surgeon based on symptoms, clinical signs and imaging findings and are scheduled for hip arthroscopy.
Minimum age
16 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include: (i) radiographic evidence of hip osteoarthritis that is more than mild in severity defined as Tonnis >grade 1; (ii) professional athlete; (iii) planning to have bilateral surgery within 24 weeks; (iv) other concurrent injury/condition that would affect performance on the rehabilitation program and/or assessment procedures; (v) unable to attend a study physiotherapist or participate in the rehabilitation program if randomised to the physiotherapy group; (vi) planning to undertake formal supervised rehabilitation following hip arthroscopy; and (vii) inability to understand English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Consecutively numbered, sealed, opaque envelopes containing group allocation will be prepared by a researcher with no other involvement in the study. The envelopes will be stored in a locked location and will be opened in sequence to reveal group allocation by a researcher not involved in recruitment or assessment of outcomes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared by the study biostatistician using computer generated random permuted blocks of varying size, and stratified according to orthopaedic surgeon so that each surgeon contributes approximately equal numbers in each group to control for surgical variation. Participants randomised to the physiotherapy group will choose their preferred project physiotherapist according to geographical convenience.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A biostatistician will oversee the blinded analyses of the data. Main comparative analyses between groups will be performed using an intention-to-treat analysis. For continuous outcome measures, differences in mean change (baseline minus follow-up) will be compared between groups using linear regression random effects modelling adjusted for baseline values of the outcome

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/04/2013
Actual
8/07/2013
Date of last participant enrolment
Anticipated
30/06/2014
Actual
25/06/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 6466 0
3121 - Richmond
Recruitment postcode(s) [2] 6467 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 286850 0
Government body
Name [1] 286850 0
National Health and Medical Research Council Program Grant
Country [1] 286850 0
Australia
Funding source category [2] 286851 0
Hospital
Name [2] 286851 0
St Vincent’s Private Hospital
Country [2] 286851 0
Australia
Funding source category [3] 286852 0
Charities/Societies/Foundations
Name [3] 286852 0
The Australian Hip Arthroscopy Education and Research Foundation
Country [3] 286852 0
Australia
Funding source category [4] 286853 0
Charities/Societies/Foundations
Name [4] 286853 0
YMCA Victoria
Country [4] 286853 0
Australia
Primary sponsor type
Individual
Name
Professor Kim Bennell
Address
Centre for Health, Exercise and Sports Medicine
Department of Physiotherapy
University of Melbourne
Victoria 3010
Country
Australia
Secondary sponsor category [1] 285642 0
Charities/Societies/Foundations
Name [1] 285642 0
The Australian Hip Arthroscopy Education and Research Foundation
Address [1] 285642 0
21 Erin Street
Richmond Victoria 3121
Country [1] 285642 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288915 0
Human Research Ethics Committee
Ethics committee address [1] 288915 0
Ethics committee country [1] 288915 0
Australia
Date submitted for ethics approval [1] 288915 0
Approval date [1] 288915 0
19/10/2012
Ethics approval number [1] 288915 0
1238190

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38318 0
Prof Kim Bennell
Address 38318 0
Director
Centre for Health, Exercise and Sports Medicine,
Department of Physiotherapy, School of Health Sciences, University of Melbourne Victoria 3010
Country 38318 0
Australia
Phone 38318 0
+61 3 83444135
Fax 38318 0
Email 38318 0
[email protected]
Contact person for public queries
Name 38319 0
Libby Spiers
Address 38319 0
Research Assistant
Centre for Health, Exercise and Sports Medicine,
Department of Physiotherapy, School of Health Sciences, University of Melbourne Victoria 3010
Country 38319 0
Australia
Phone 38319 0
+61 3 90353886
Fax 38319 0
Email 38319 0
[email protected]
Contact person for scientific queries
Name 38320 0
Kim Bennell
Address 38320 0
Director
Centre for Health, Exercise and Sports Medicine,
Department of Physiotherapy, School of Health Sciences, University of Melbourne Victoria 3010
Country 38320 0
Australia
Phone 38320 0
+61 3 83444135
Fax 38320 0
Email 38320 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEfficacy of adding a physiotherapy rehabilitation programme to arthroscopic management of femoroacetabular impingement syndrome: A randomised controlled trial (FAIR).2017https://dx.doi.org/10.1136/bmjopen-2016-014658
N.B. These documents automatically identified may not have been verified by the study sponsor.