Shelf Acetabuloplasty With 3D Printed Implants as a New Treatment for Symptomatic Adult Hip Dyspl… (NCT07072832) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Shelf Acetabuloplasty With 3D Printed Implants as a New Treatment for Symptomatic Adult Hip Dysplasia
Netherlands10 participantsStarted 2025-08-08
Plain-language summary
Hip dysplasia is a common orthopedic condition, defined as an abnormality in the shape, size and orientation of the femoral head, acetabulum or both. The most frequent presentation of hip dysplasia is the maldevelopment of the acetabulum, resulting in insufficient superior coverage of the femoral head, defined as a lateral center-edge angle (Wiberg) of less than 20 degrees. Patients suffer from groin pain, an abnormal gait, decreased strength, and an increased rate of degenerative hip disease.
The possible treatments affecting the shape of the acetabulum once the patient reaches adolescence are all surgical. The PAO is regarded as the current gold standard in the treatment of symptomatic adult hip dysplasia. The 3-dimensional orientation of the acetabulum is changed with the use of 3 osteotomies around the acetabulum and a refixation in the obtained position. However, the PAO is a difficult operation and is associated with a large number of major complications (up to 37%), and the surgery is associated with a long rehabilitation period.
Hence, a strong unmet need exists for an effective but less invasive solution that enhances the quality of life of adult hip dysplasia patients. The treatment gap can be filled with a 3-dimensional (3D) shelf procedure. This custom-made implant (called the 3D-Shelf implant) was developed with the goal to be more predictable in terms of containment and fit than the old autologous shelf-acetabuloplasty, and less invasive and easier to perform than the PAO.
This study aims to study the safety and evaluate the early performance in terms of the clinical outcomes after implantation of the 3D-Shelf implant in patients with adult hip dysplasia, to show that the 3D-Shelf procedure is safe, has lower complication rates, and shows no inferiority in clinical outcomes compared to the current treatment of a peri-acetabular osteotomy.
Who can participate
Age range
18 Years – 45 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 dysplasia based on AP x-ray with a LCEA of \<25°
* Groin pain and/or gait abnormalities, with no other explanatory hip pathology
* Aged at least 18 years and maximal 45 years at time of surgery (indicated age for PAO(19))
* Willing to comply with the study visit schedule during 12 month follow-up
* Able and willing to provide informed consent
Exclusion Criteria:
* Previous acetabular surgery \>10yr of age
* Signs of osteoarthritis on x-ray (Tonnis classification \>1),
* Body mass index of more than 35
* Large labral tears visible on non-contrast MRI
* Pre-consultation known titanium allergy
* Pre-consultation known medical histories of diseases that per the investigator possibly affect the outcome: neuromuscular disease affecting the stability of the hip, diseases affecting bone ingrowth and fixation strength of the implant like rheumatoid arthritis and metabolic bone diseases, e.g. osteomalacie, osteoporosis, hyperparathyroidism, hypercalcemia.
* Pre-consultation known pregnant women or women who are planning to become pregnant during the duration of the study.
* Part of vulnerable population (e.g. Mentally disabled with cognitive impairment or mental disease)
* Currently participating in another investigational clinical trial.
* Unable to provide informed consent (e.g. insufficient language skills)
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
PROMs
Timeframe: from baseline (pre-surgery), 3 months, 6 months and 12 months.