The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR
Registration number
ACTRN12617000462381
Ethics application status
Approved
Date submitted
3/03/2017
Date registered
30/03/2017
Date last updated
13/06/2019
Date data sharing statement initially provided
13/06/2019
Date results information initially provided
13/06/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
IMBRACE: Can a specialised hip BRACE alleviate symptoms of hip IMpingement? A randomised controlled trial comparing a hip brace plus usual care to usual care alone.
Query!
Scientific title
IMBRACE: Can a specialised hip BRACE alleviate symptoms of hip IMpingement? A randomised controlled trial comparing a hip brace plus usual care to usual care alone.
Query!
Secondary ID [1]2911180
Nil known
Query!
Universal Trial Number (UTN)
U1111-1192-8636
Query!
Trial acronym
IMBRACE
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Femoroacetabular impingement (FAI)3020220
Query!
Acetabular labral tear3020230
Query!
Condition category
Condition code
Musculoskeletal30166330166300
Query!
Other muscular and skeletal disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Participants randomly allocated into the ‘hip brace’ arm will receive their usual non-surgical care, plus will be provided with a hip brace, designed by Ossur, to wear for the six weeks of the study. The hip brace comprises an elastic strap with loading mechanism that wraps around the affected leg, and a compressive pelvic belt that wraps around the pelvis and gluteal region. Participants will attend an appointment with an orthotist or trained research assistant, during which their hip brace will be fitted in an appointment lasting appproximately one hour. Participants will be advised to wear the hip brace for approximately two hours per day in the first week of the study, approximately four hours per day in the second week, and four hours or more in the third week of the study and thereafter (there is no maximum amount of time that participants are permitted to wear the brace each day). After one week, participants will attend a follow up fitting appointment (approx. 30 mins duration), during which it will be checked that their hip brace fits well and they are wearing it correctly. Participants will be allowed to keep their hip brace following the six weeks of the study. Participants in the treatment group will also be asked via questionnaire about the additional treatments they access during the six weeks of the study. All participants in the treatment group will be referred for an EOS scan at baseline.
Query!
Intervention code [1]2971550
Treatment: Devices
Query!
Comparator / control treatment
Controls for the hip brace study will receive usual non-surgical care, i.e. the non-surgical treatment they would normally receive, during the six weeks of the study. Controls will be asked via questionnaire about the treatments they access during the six weeks of the study. All participants in the control group will be referred for an EOS scan at baseline. A case-control sub-study will be carried out comparing the EOS scans from participants with FAI and/or symptomatic labral tears in this study, to EOS scans from an asymptomatic cohort in a previous study. Permission has already been obtained to use the images from this previous study. Participants in the previous study were required to have no significant degree of leg or back pain within the previous six months nor any previous spinal, hip or knee surgery, and thus are appropriate for our use as an asymptomatic comparator group.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]3010550
Change in hip-specific health-related quality of life, as measured by changes in score on the international Hip Outcome Tool (iHOT-33).
Query!
Timepoint [1]3010550
6 weeks
Query!
Secondary outcome [1]3316020
Change in hip symptoms as assessed by the Copenhagen Hip and Groin Outcome Score (HAGOS).
Query!
Timepoint [1]3316020
6 weeks
Query!
Secondary outcome [2]3316030
FAI brace tolerability as reflected by QUEST survey scores (Quebec User Evaluation of Satisfaction with assistive Technology survey).
Query!
Timepoint [2]3316030
6 weeks
Query!
Secondary outcome [3]3316040
Change in hip-specific health-related quality of life, as measured by changes in score on the international Hip Outcome Tool (iHOT-33).
Query!
Timepoint [3]3316040
6 months, 12 months
Query!
Secondary outcome [4]3316060
Alpha angle, measured on EOS scan
Query!
Timepoint [4]3316060
Baseline
Query!
Secondary outcome [5]3331900
Pelvic tilt measured on EOS scans in postures of standing, sitting, and hip flexion.
Query!
Timepoint [5]3331900
Baseline
Query!
Secondary outcome [6]3331910
Leg length inequality, measured as difference between femoral plus tibial lengths between the right and left legs on EOS scans.
Query!
Timepoint [6]3331910
Baseline
Query!
Secondary outcome [7]3332770
Lateral centre edge angle, measured on EOS scan
Query!
Timepoint [7]3332770
Baseline
Query!
Secondary outcome [8]3332780
Femoral neck shaft angle, measured on EOS scan
Query!
Timepoint [8]3332780
Baseline
Query!
Secondary outcome [9]3332790
Acetabular version, measured on EOS scan
Query!
Timepoint [9]3332790
Baseline
Query!
Secondary outcome [10]3332800
Femoral version, measured on EOS scan
Query!
Timepoint [10]3332800
Baseline
Query!
Eligibility
Key inclusion criteria
Inclusion criteria for hip brace study: Inclusion criteria for asymptomatic comparator EOS scans:
* Age >18 years
* Symptoms of hip pain - patients may also have symptoms of clicking, catching or giving way;
* Patient has been diagnosed with symptomatic femoroacetabular impingement OR an acetabular labral tear causing hip symptoms by a study orthopaedic surgeon.
* The patient is able to give written informed consent and to participate fully in the interventions and follow-up procedures.
* Over 18 years of age
* Willing to have EOS scan
Query!
Minimum age
18Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Evidence of pre-existing osteoarthritis, defined as Tonnis grade >1 on AP pelvic radiograph; Exclusion criteria for asymptomatic comparator EOS scans:
* Previous significant hip pathology such as Perthes’ disease, slipped upper femoral epiphysis, developmental dysplasia of the hip, or avascular necrosis;
* Previous hip injury such as acetabular fracture, hip dislocation or femoral neck fracture.
* Previous shape changing surgery (open or arthroscopic) in the affected hip, or surgery planned for within the next six weeks.
* Significant degree of leg or back pain within the previous six months.
* Previous spinal, hip or knee surgery.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealmentprocedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequencegeneration)
Query!
Masking / blinding
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Date of first participant enrolment
Anticipated
1/04/2017
Query!
Actual
6/07/2017
Query!
Date of last participant enrolment
Anticipated
31/10/2018
Query!
Actual
31/10/2018
Query!
Date of last data collection
Anticipated
31/10/2019
Query!
Actual
Query!
Sample size
Target
62
Query!
Accrual to date
Query!
Final
38
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]76010
Royal North Shore Hospital - St Leonards
Query!
Recruitment postcode(s) [1]155000
2065 - St Leonards
Query!
Funding & Sponsors
Funding source category [1]2955570
Commercial sector/Industry
Query!
Name [1]2955570
Ossur
Query!
Country [1]2955570
Iceland
Query!
Primary sponsor type
University
Query!
Name
University of Sydney
Query!
Address
University of Sydney
Camperdown
NSW 2006
Australia
Query!
Country
Australia
Query!
Secondary sponsor category [1]2946780
None
Query!
Name [1]2946780
Query!
Address [1]2946780
Query!
Country [1]2946780
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]2968780
North Sydney Local Health District
Query!
Ethics committee address [1]2968780
Research Office
Kolling Building, Level 13
Royal North Shore Hospital
St Leonards
NSW 2065
Query!
Ethics committee country [1]2968780
Australia
Query!
Date submitted for ethics approval [1]2968780
08/08/2016
Query!
Approval date [1]2968780
10/10/2016
Query!
Ethics approval number [1]2968780
HREC/16/HAWKE/285
Query!
Summary
Brief summary
What is the study purpose? What does the study involve? Here is some further information about each of the two treatments : 1. Treatment with the hip brace 2. Normal treatment All people participating in this study will go for an EOS scan (a special type of low radiation dose X-ray). This will help the researchers to measure the extent of each participant's hip impingement.
The purpose of this study is to investigate whether a specially-designed hip brace is effective for treating hip impingement. We hypothesise that the hip brace will help alleviate hip pain for people with hip impingement.
Participation in this study goes for six weeks. This type of study is known as a ‘randomised trial’. Since we don’t yet know whether the hip brace is effective in treating hip impingement, we need to compare it to the usual treatment people receive. To do this, study participants are put into two groups: one group using the hip brace as well as the normal treatment their doctor would recommend, and the other group just having the normal treatment their doctor would recommend for hip impingement. To ensure the groups are similar to start with, a computer allocates each study participant into a group randomly, like the flip of a coin. Participants will fill out questionnaires about their hip symptoms before beginning the study, and then also fill out the questionnaires after six weeks, allowing the researchers to compare results between the two groups to see which treatment is better.
The hip brace is a new device that has been designed by Ossur, a company that develops and manufactures non-invasive orthopaedic equipment. The brace has been made for people with hip impingement, with the purpose of reducing their hip symptoms. There has not been any previous study on the effectiveness of this hip brace for hip impingement, so we don’t yet know if it is effective or not. People allocated to receive treatment with the hip brace can still continue with the normal treatment for their hip recommended by their doctor. However they cannot have surgery during the six weeks of the study and cannot start any other new treatments that their doctor has not recommended. Participants allocated to the hip brace gorup will receive the hip brace at no cost to them, and will be free to keep the hip brace after the study is over.
Participants allocated to receive normal treatment will be asked to simply proceed with the normal treatment that your doctor recommends for your hip impingement (apart from surgery). Participants allocated to normal treatment will not be given a hip brace to use.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name723100
Prof David Hunter
Query!
Address723100
Rheumatology Department
Level 7, Royal North Shore Hospital
Pacific Highway
St Leonards
NSW 2065
Query!
Country723100
Australia
Query!
Phone723100
+612 9463 1887
Query!
Fax723100
Query!
Email723100
[emailprotected]
Query!
Contact person for public queries
Name723110
Mrs Jillian Eyles
Query!
Address723110
Rheumatology Department
Level 7, Royal North Shore Hospital
Pacific Highway
St Leonards
NSW 2065
Query!
Country723110
Australia
Query!
Phone723110
+612 9463 1773
Query!
Fax723110
Query!
Email723110
[emailprotected]
Query!
Contact person for scientific queries
Name723120
Prof David Hunter
Query!
Address723120
Rheumatology Department
Level 7, Royal North Shore Hospital
Pacific Highway
St Leonards
NSW 2065
Query!
Country723120
Australia
Query!
Phone723120
+612 9463 1887
Query!
Fax723120
Query!
Email723120
[emailprotected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Individual participant data cannot be shared for this trial.
Query!
What supporting documents are/will be available?
Current supporting documents:
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
| Source | Title | Year of Publication | DOI |
|---|---|---|---|
| Embase | Can a Hip Brace Improve Short-Term Hip-Related Quality of Life for People With Femoroacetabular Impingement and Acetabular Labral Tears: An Exploratory Randomized Trial. | 2022 | https://dx.doi.org/10.1097/JSM.0000000000000974 |
N.B. These documents automatically identified may not have been verified by the study sponsor.
