None listed
Conditions
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.
Interventions
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 w
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.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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.
Outcome results
None listed