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This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.
The study is designed as a prospective, multi-center, non-randomized study. It is designed to evaluate the effects of metal-on-metal acetabular articulating bearing surfaces.
The device will be used in conjunction with a cemented metal femoral resurfacing prosthesis.
The objective of this clinical investigation is to evaluate the safety and effectiveness of the metal-on-metal Recap Total Resurfacing System.
Performance will be assessed trough Harris Hip Score, radiographic evaluation at various postoperative visits. Adverse events and revisions will be documented for safety assessments.
Primary endpoints:
Secondary endpoints:
I. Acetabular component migration, change in angle of inclination or presence of osteolysis II. Femoral component subsidence, femoral neck Fracture or presence of osteolysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReCap | Other | ReCap Total Hip Resurfacing System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReCap Total Hip Resurfacing System | Device | This is a hip resurfacing system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score, Device Revision/Removal, Radiographic Evaluation | 2 years postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Anytime |
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Inclusion Criteria:
Patients with a preoperative Total Harris Hip Score of < 70
Conservative treatment has proven unsuccessful
Primary hip surgery
Patients requiring hip resurfacing for degenerative joint disease (inflammatory or non- inflammatory) or any of the composite diagnoses of:
6. Patients of all races and gender 7. Patients who are able to follow post-operative care instructions 8. Patients who are willing and able to return for scheduled follow-up evaluations 9. Patient has signed the IRB approved Informed Consent Form
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jo De Schepper, MD | AZ Nikolaas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Az Nikolaas Campus Sint Niklaas | Sint-Niklaas | Belgium |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |