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Clinical Trial

Shelf Acetabuloplasty With 3D Printed Implants as a New Treatment for Symptomatic Adult Hip Dysplasia

NCT: NCT07072832 · ACTIVE_NOT_RECRUITING

NCT IDNCT07072832
StatusACTIVE_NOT_RECRUITING
Start Date2025-08-08
Completion2028-02
SponsorReplasia BV (INDUSTRY)
First posted
Last updated

Brief 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.

Frequently Asked Questions

What is Shelf Acetabuloplasty With 3D Printed Implants as a New Treatment for Symptomatic Adult Hip Dysplasia?

Shelf Acetabuloplasty With 3D Printed Implants as a New Treatment for Symptomatic Adult Hip Dysplasia is a clinical trial registered under NCT07072832. Current status: ACTIVE_NOT_RECRUITING.

What is the status of NCT07072832?

The current status of NCT07072832 (Shelf Acetabuloplasty With 3D Printed Implants as a New Treatment for Symptomatic Adult Hip Dysplasia) is: ACTIVE_NOT_RECRUITING.

When did Shelf Acetabuloplasty With 3D Printed Implants as a New Treatment for Symptomatic Adult Hip Dysplasia start?

Shelf Acetabuloplasty With 3D Printed Implants as a New Treatment for Symptomatic Adult Hip Dysplasia started on 2025-08-08.

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Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.