Acetabular dysplasia underdeveloped hip joint Underdeveloped hip joint
Conditions
Interventions
Prior to the surgery the patients will need a CT scan and a MRI scan to design
the patient specific implant. The patients will be admitted to the hospital for
implantation of the 3D-Shelf, and will
Sponsors
Replasia
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Hip dysplasia based on AP x-ray with a LCEA of
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study objectives are an evaluation of the safety, feasibility and the performance after implantation of the 3D-Shelf implant. The safety will be evaluated by incidence, nature, and severity of procedure- and/or device-related adverse events up to 12 months post-surgery, with an interim analysis 6 months after the first 5 patients have undergone surgery. The clinical performance will be evaluated by describing the change from baseline in widely used questionnaires for the evaluation of osteoarthritis and/or hip surgeries, which cover aspects such as pain, range of motion (ROM), functioning in activities of daily life (ADL), gait, and quality of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| The placement of the implant will be evaluated based on the accurate positioning of the implant and the technical feasibility of the surgery. Difficulties or deviations from the surgical protocol will be described. The implant positioning will be assessed by comparing the post-operative CT-scan to the pre-operative CT-scan and the planning of the implant. To analyse potential predisposing risk factors for an unsuccessful outcome, the clinical outcomes of the implantation of the 3D-Shelf will be correlated with possible predisposing factors. | — |
Countries
Netherlands
Contacts
Public ContactA. Meynen
Replasia
Outcome results
None listed