Actively Recruiting
Shelf Acetabuloplasty With 3D Printed Implants as a New Treatment for Symptomatic Adult Hip Dysplasia
Led by Replasia BV · Updated on 2025-10-07
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Hip dysplasia is a common orthopedic condition characterized by abnormal shape, size, or orientation of the femoral head and acetabulum, leading to groin pain, abnormal walking, reduced strength, and faster joint degeneration. Adolescents and adults with symptomatic hip dysplasia typically undergo surgery, with the peri-acetabular osteotomy (PAO) being the current standard treatment despite its complexity and risk of major complications. Researchers are exploring a less invasive option using a custom 3D-printed implant called the 3D-Shelf to improve treatment outcomes and reduce risks. This study evaluates the safety and early clinical performance of the 3D-Shelf implant in adult patients with hip dysplasia. The procedure aims to offer better fit and containment than older methods and be less invasive than PAO surgery. The trial includes two sequential patient groups, starting with five patients in a safety cohort followed by five in a performance cohort, all receiving the 3D-Shelf device to treat their condition. Participants will be followed for 12 months after surgery, with evaluations including patient-reported outcome measures at baseline, 3, 6, and 12 months. Researchers will also assess implant positioning shortly after surgery and at 12 months, track recovery progress, and monitor surgical risks throughout the follow-up period. Patients will attend scheduled visits and provide informed consent, with the study designed to track safety and effectiveness over one year.
CONDITIONS
Brief Title
Shelf Acetabuloplasty With 3D Printed Implants as a New Treatment for Symptomatic Adult Hip Dysplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hip dysplasia confirmed by AP X-ray with a lateral center-edge angle less than 25 degrees
- Groin pain and/or abnormal gait with no other hip pathology
- Aged between 18 and 45 years at time of surgery
- Willing to comply with study visits during 12-month follow-up
- Able and willing to provide informed consent
You will not qualify if you...
- Previous acetabular surgery more than 10 years ago
- Signs of osteoarthritis on X-ray with Tonnis classification greater than 1
- Body mass index over 35
- Large labral tears visible on non-contrast MRI
- Known allergy to titanium
- Known neuromuscular disease affecting hip stability
- Diseases affecting bone ingrowth or implant fixation such as rheumatoid arthritis or metabolic bone diseases
- Pregnant women or women planning pregnancy during the study
- Part of vulnerable populations such as mentally disabled with cognitive impairment or mental disease
- Currently participating in another investigational clinical trial
- Unable to provide informed consent due to language or other barriers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive the 3D printed 3D-Shelf implant as a treatment for hip dysplasia.
1 surgery visit
Duration - 24 hours after surgery
Participants receive immediate post-operative care following their implant surgery.
1 post-operative visit
Duration - 12 months
Participants attend follow-up visits to monitor recovery, implant position, and surgical risks up to 12 months after surgery.
Visits at 3 months, 6 months, and 12 months post-surgery
Trial Site Locations
Total: 1 location
1
Anna Ziekenhuis
Geldrop, Netherlands, 5664 BE
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here