Hip DysplasiaNCT07072832
Shelf Acetabuloplasty With 3D Printed Implants as a New Treatment for Symptomatic Adult Hip Dysplasia
A study testing 3D-Shelf in people with Hip Dysplasia, run by Replasia BV at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Hip Dysplasia
- What is being tested?
- 3D-Shelf
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Aug 2025to Feb 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
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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.
- Conditions
- Hip Dysplasia
- Being tested
- 3D-Shelf
- Keywords
- Dysplasia, Hip, Adult, Preservation, Shelf
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-ShelfDevice
Treatment of hip dysplasia using novel 3D printed 3D-Shelf device.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Consisting of two sequential cohorts. Five patients first treated in safety cohort, five patients after in performance cohort. Receives: Device: 3D-Shelf |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline (pre-surgery), 3 months, 6 months and 12 months.
Secondary outcomes (3)
Implant position
Evaluation of the implant position using CT
Measured: 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.
Measured: 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.
Measured: From surgery to end of follow-up (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start8 Aug 2025
- Primary completion1 Feb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Replasia BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072832
- Sponsor's protocol ID
- version 1.2 d.d 28-11-2024
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be determined.