ANZCTR - Registration

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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.

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.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1192-8636

Trial acronym

IMBRACE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Femoroacetabular impingement (FAI)

Acetabular labral tear

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

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.

Intervention code [1]

Treatment: Devices

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.

Control group

Active

Outcomes

Primary outcome [1]

Change in hip-specific health-related quality of life, as measured by changes in score on the international Hip Outcome Tool (iHOT-33).

Timepoint [1]

6 weeks

Secondary outcome [1]

Change in hip symptoms as assessed by the Copenhagen Hip and Groin Outcome Score (HAGOS).

Timepoint [1]

6 weeks

Secondary outcome [2]

FAI brace tolerability as reflected by QUEST survey scores (Quebec User Evaluation of Satisfaction with assistive Technology survey).

Timepoint [2]

6 weeks

Secondary outcome [3]

Change in hip-specific health-related quality of life, as measured by changes in score on the international Hip Outcome Tool (iHOT-33).

Timepoint [3]

6 months, 12 months

Secondary outcome [4]

Alpha angle, measured on EOS scan

Timepoint [4]

Baseline

Secondary outcome [5]

Pelvic tilt measured on EOS scans in postures of standing, sitting, and hip flexion.

Timepoint [5]

Baseline

Secondary outcome [6]

Leg length inequality, measured as difference between femoral plus tibial lengths between the right and left legs on EOS scans.

Timepoint [6]

Baseline

Secondary outcome [7]

Lateral centre edge angle, measured on EOS scan

Timepoint [7]

Baseline

Secondary outcome [8]

Femoral neck shaft angle, measured on EOS scan

Timepoint [8]

Baseline

Secondary outcome [9]

Acetabular version, measured on EOS scan

Timepoint [9]

Baseline

Secondary outcome [10]

Femoral version, measured on EOS scan

Timepoint [10]

Baseline

Eligibility

Key inclusion criteria

Inclusion criteria for hip brace study:
* 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.

Inclusion criteria for asymptomatic comparator EOS scans:
* Over 18 years of age
* Willing to have EOS scan

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* Evidence of pre-existing osteoarthritis, defined as Tonnis grade >1 on AP pelvic radiograph;
* 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.

Exclusion criteria for asymptomatic comparator EOS scans:
* Significant degree of leg or back pain within the previous six months.
* Previous spinal, hip or knee surgery.

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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

1/04/2017

Actual

6/07/2017

Date of last participant enrolment

Anticipated

31/10/2018

Actual

31/10/2018

Date of last data collection

Anticipated

31/10/2019

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal North Shore Hospital - St Leonards

Recruitment postcode(s) [1]

2065 - St Leonards

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Ossur

Address [1]

Ossur Iceland Corporate Office
Grjothals 110,
Reykjavík,
Iceland

Country [1]

Iceland

Primary sponsor type

University

Name

University of Sydney

Address

University of Sydney
Camperdown
NSW 2006
Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

North Sydney Local Health District

Ethics committee address [1]

Research Office
Kolling Building, Level 13
Royal North Shore Hospital
St Leonards
NSW 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/08/2016

Approval date [1]

10/10/2016

Ethics approval number [1]

HREC/16/HAWKE/285

Summary

Brief summary

What is the study purpose?
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.

What does the study involve?
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.

Here is some further information about each of the two treatments :

1. Treatment with the hip brace
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.

2. Normal treatment
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.

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof David Hunter

Address

Rheumatology Department
Level 7, Royal North Shore Hospital
Pacific Highway
St Leonards
NSW 2065

Country

Australia

Phone

+612 9463 1887

Fax

[email protected]

Contact person for public queries

Name

Mrs Jillian Eyles

Address

Rheumatology Department
Level 7, Royal North Shore Hospital
Pacific Highway
St Leonards
NSW 2065

Country

Australia

Phone

+612 9463 1773

Fax

[email protected]

Contact person for scientific queries

Name

Prof David Hunter

Address

Rheumatology Department
Level 7, Royal North Shore Hospital
Pacific Highway
St Leonards
NSW 2065

Country

Australia

Phone

+612 9463 1887

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Individual participant data cannot be shared for this trial.

What supporting documents are/will be available?

Current supporting documents:

Updated to:

Doc. No.	Type	Email
23488	Study protocol	[email protected]
23489	Informed consent form	[email protected]
23490	Ethical approval	[email protected]

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.

Trial Review

Documents added manually

Documents added automatically