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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Consisting of two sequential cohorts. Five patients first treated in safety cohort, five patients after in performance cohort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D-Shelf | Device | Treatment of hip dysplasia using novel 3D printed 3D-Shelf device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PROMs | Performance and safety will be evaluated using patient-reported outcome measures, specifically the International Hip Outcome Tool (iHOT-33), which assesses health-related quality of life in young, active patients with hip disorders. Scores range from 0 to 100, with higher scores indicating better outcomes. | from baseline (pre-surgery), 3 months, 6 months and 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Implant position | Evaluation of the implant position using CT | 24 hours after surgery and 12 months after surgery |
| Recovery time | Patient recovery will be evaluated through a combination of patient-reported and clinical outcomes. Patient-reported outcomes include the International Hip Outcome Tool (iHOT-33), which ranges from 0 to 100 with higher scores indicating better function and quality of life, and the EQ-5D. Clinical assessment will include evaluation of hip range of motion and return to normal function as judged by the investigator. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anna Ziekenhuis | Recruiting | Geldrop | 5664 BE | Netherlands |
To be determined.
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| ID | Term |
|---|---|
| D006617 | Hip Dislocation |
| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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| From 3 months, 6 months and 12 months |
| Surgical risks | Evaluation of surgical risks will include monitoring and documentation of surgery-related adverse events and any deviations from the planned surgical procedure. | From surgery to end of follow-up (12 months) |
| D025981 |
| Hip Injuries |