An interventional study of 3D-Shelf in Hip Dysplasia, sponsored by Replasia BV. Active, not recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-08-10.
Sponsored by Replasia BV · Not applicable, Interventional, and Treatment
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.
107 studies on the registry are indexed under Hip Dislocation; 36 are open to participants now.
This study's planned enrollment of 10 is below the median of 86 across 64 interventional studies indexed under Hip Dislocation.
Browse Hip Dislocation studies →This is the only study on the registry with Replasia BV as lead sponsor.
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Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Consisting of two sequential cohorts. Five patients first treated in safety cohort, five patients after in performance cohort.
Device: 3D-Shelf
Treatment of hip dysplasia using novel 3D printed 3D-Shelf device.
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.
Time frame: from baseline (pre-surgery), 3 months, 6 months and 12 months.
Implant position
Evaluation of the implant position using CT
Time frame: 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.
Time frame: 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.
Time frame: From surgery to end of follow-up (12 months)
Plan to share: Undecided — To be determined.
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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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