A Prospective Clinical Study On A Total Hip Resurfacing System

Status Completed

Clinical Trial Summary

This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00604734
Study type	Interventional
Source	Zimmer Biomet
Contact
Status	Completed
Phase	N/A
Start date	October 2004
Completion date	October 2012

View Details

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