3D-printed shelf implant to correct adult hip dysplasia
Shelf Acetabuloplasty With 3D Printed Implants as a New Treatment for Symptomatic Adult Hip Dysplasia
This trial will try a patient-specific 3D-printed shelf implant surgery to improve hip coverage and reduce pain in adults (18–45) with symptomatic hip dysplasia and a lateral center-edge angle under 25°.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Replasia BV Industry-sponsored |
| Locations | 1 site (Geldrop) |
| Trial ID | NCT07072832 on ClinicalTrials.gov |
What this trial studies
The procedure uses a patient-specific 3D-printed shelf implant fixed to the acetabular rim to increase superior coverage of the femoral head as an alternative to periacetabular osteotomy (PAO). Adults aged 18–45 with symptomatic hip dysplasia (LCEA <25°), minimal osteoarthritis, and no major contraindications are eligible and will be followed for 12 months postoperatively. Investigators will record pain, gait and functional scores, implant fixation on imaging, and complications to judge safety and clinical effect. The aim is to provide a technically simpler surgical option with potentially fewer major complications than PAO.
Who should consider this trial
Good fit: Adults aged 18–45 with symptomatic lateral hip dysplasia (LCEA <25°), groin pain or gait problems, minimal osteoarthritis, BMI ≤35, no large labral tears or known titanium allergy, and willing to attend 12‑month follow-up are ideal candidates.
Not a fit: Patients with advanced osteoarthritis (Tönnis >1), large labral tears, significant metabolic bone disease, known titanium allergy, very high BMI, or those with prior acetabular procedures are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could reduce pain and improve hip stability while offering a less complex surgical option with potentially fewer major complications than the current PAO.
How similar studies have performed: Periacetabular osteotomy is an established successful treatment for symptomatic dysplasia, but using 3D-printed shelf implants is a novel approach with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Geldrop
- Anna Ziekenhuis — Geldrop, Netherlands (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.