Exercise and Patient Education Compared With Usual Care in Patients With Hip Dysplasia (NCT04795843) | Clinical Trial Compass
RecruitingNot Applicable
Exercise and Patient Education Compared With Usual Care in Patients With Hip Dysplasia
Denmark200 participantsStarted 2021-04-16
Plain-language summary
This effectiveness trial will investigate if patients with hip dysplasia randomised to exercise and patient education have a different mean change in self-reported pain measured by the Copenhagen Hip and Groin Outcome Score (HAGOS) compared with those randomised to usual care over a six-month follow-up period.
Participating patients will be allocated to either exercise and patient education or usual care. Alongside this, a health-economic study and a process-evaluation study will be conducted.
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:
* Radiographically verified hip dysplasia by a Wiberg's centre edge (CE) angle of 10-25 degrees and an acetabular Index (AI) angle \>10 degrees
* Hip and/or groin pain as primary pain for at least three months
* Candidate for periacetabular osteotomy (PAO) but unwilling to undergo PAO, or on a waiting list for surgery (PAO) for 12 months or longer
* Not candidate for PAO (negative impingement test, BMI \>25, hip osteoarthritis, age \>45 years or reduced hip range of motion)
Exclusion Criteria:
* Self-reported pain score \>80 points measured with Copenhagen Hip and Groin outcome score
* Any major planned surgery (i.e. arthroplastic surgery or discectomy surgery)
* BMI \>35
* Acetabular retroversion defined by crossover sign and posterior wall sign
* Calvé Legg Perthes or epiphysiolysis
* Previous pelvic/hip surgery in index limb
* Previous pelvic/hip surgery within the last 2 years in contralateral limb
* Previous surgery due to herniated disc or spondylodesis
* Previous arthroplastic surgery in the hip, knee or ankle
* Physical (pregnancy/trauma), neurological, medical or rheumatic conditions severely affecting the hip function
* Inadequacy in written and spoken Danish, mental illness or other conditions affecting the ability to follow mandatory procedures for participation
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
Change in self-reported pain measured with The Copenhagen Hip and Groin Outcome Score (HAGOS) (continuous data)
Timeframe: From baseline to 6-month follow-up. Outcome measured at baseline, 3- and 6-month follow-up. In addition at 9- and 12-month follow-up (health economic study) and after 2, 5 and 10 years (describing if hip osteoarthritis progresses over time)