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| Sponsor: | Biomet, Inc. |
|---|---|
| Information provided by (Responsible Party): | Biomet, Inc. |
| ClinicalTrials.gov Identifier: | NCT00604734 |
Purpose
This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.
| Condition | Intervention |
|---|---|
|
Arthritis Avascular Necrosis |
Device: ReCap Total Hip Resurfacing System |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Clinical Study On A Total Hip Resurfacing System |
| Estimated Enrollment: | 500 |
| Study Start Date: | October 2004 |
| Estimated Study Completion Date: | October 2017 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
ReCap
ReCap Total Hip Resurfacing System
|
Device: ReCap Total Hip Resurfacing System
This is a hip resurfacing system.
Other Names:
|
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
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Contacts and Locations| Contact: Fabienne Lambert | 32-3 870 65 77 | fabienne.lambert@biomet.com |
| Belgium | |
| Az Nikolaas Campus Sint Niklaas | Recruiting |
| Sint Niklaas, Belgium | |
| Contact: Fabienne Lambert 32-3 870 65 77 fabienne.lambert@biomet.com | |
| Principal Investigator: | H P Delport, MD | AZ NIKOLAAS CAMPUS SINT NIKLAAS |
| Principal Investigator: | Jo De Schepper, MD | AZ NIKOLAAS CAMPUS SINT NIKLAAS |
More Information
| Responsible Party: | Biomet, Inc. |
| ClinicalTrials.gov Identifier: | NCT00604734 History of Changes |
| Other Study ID Numbers: | EU-8 |
| Study First Received: | December 23, 2007 |
| Last Updated: | August 29, 2011 |
| Health Authority: | Belgium: Ministry of Social Affairs, Public Health and the Environment |
|
Arthritis Necrosis Osteonecrosis Joint Diseases |
Musculoskeletal Diseases Pathologic Processes Bone Diseases |