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: * Total Harris hip score * Device revisions or removals Secondary endpoints: * Total Harris hip score * Radiographic changes as evidenced by: I. Acetabular component migration, change in angle of inclination or presence of osteolysis II. Femoral component subsidence, femoral neck Fracture or presence of osteolysis
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
280
This is a hip resurfacing system.
Az Nikolaas Campus Sint Niklaas
Sint-Niklaas, Belgium
Harris Hip Score, Device Revision/Removal, Radiographic Evaluation
Time frame: 2 years postoperative
Complications
Time frame: Anytime
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