Arthroscopic Surgical Procedures vs Sham Surgery for Patients With Femoroacetabular Impingement a… (NCT02692807) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Arthroscopic Surgical Procedures vs Sham Surgery for Patients With Femoroacetabular Impingement and/or Labral Tears.
Australia, Norway140 participantsStarted 2016-02
Plain-language summary
The primary aim of this study is to determine the efficacy of hip arthroscopic surgery compared to a sham surgery (diagnostic arthroscopy only) for patients with symptomatic and radiological findings related to impingement (FAI) and/or labral tears using a randomized controlled design (HIPARTI Study: Primary aim and the main paper: primary end point: iHOT 1 year follow-up)).
Our main hypothesis is that surgical procedures of the hip will demonstrate greater efficacy than sham surgery (diagnostic hip arthroscopy only) for hip related quality of life (iHOT-33) after 1 year and at further (HIPARTI Study).
The secondary aim of this study is to establish modifiable risk factors associated with pain, function, work participation and quality of life over 1 year in people aged 18-50 years with hip impingement and/or labral tears diagnosed at hip arthroscopy. (HARP Study: A separate paper will be published with this main aim for the HARP Study) Long-term follow-ups for HIPARTI Study as well as HARP Study will be performed at 2, 5 and 10 years (secondary aims and separate papers).
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* hip pain during daily and/or spor t ing activities;
* intra-articular hip pain with radiological signs of FAI and/or labral tears eligible for hip arthroscopy (to be determined in a pragmatic fashion by the surgeon based on clinical examination and imaging
* the patient is able to give written informed consent and to participate fully in the interventions and follow-up procedures
Exclusion Criteria:
* pain that is not confirmed by physical examination of the hip
* evidence of preexisting osteoarthritis, defined as Tonnis grade \>1, or less than 3mm superior joint space width on AP pelvic radiograph
* center edge angle on radiograph \<25°; (v) previous known hip pathology such as Perthes' disease, slipped upper femoral epiphysis or avascular necrosis
* previous hip injury such as acetabular fracture, hip dislocation or femoral neck fracture
* previous hip surgery
* medical conditions complicating surgery (ASA 3); (ix) inflammatory joint disease (RA, Bechterew etc)
* physical inability to undertake testing procedures
* expected lack of compliance such as cognitive impairment, drug abuse or similar;
* inability to understand the written and spoken language of the treatment centre;
* contra-indications to placebo surgery, which will include large loose body, chondral flap \>1cm2 detached at 3 sides, complete labral radial flap tear and labral bucket-handle tear with complete avulsion \>1.5cm long
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
International Hip Outcome Tool (IHOT-33)
Timeframe: Baseline, 6,12 an 24 months follow-ups - 1 year follow-up is main outcome