NCT00604734

A Prospective Clinical Study On A Total Hip Resurfacing System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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

Detailed 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

Conditions

• Arthritis
• Avascular Necrosis

Interventions

Type	Name	Description
DEVICE	ReCap Total Hip Resurfacing System	This is a hip resurfacing system.

Timeline

• Start date: 2004-10-01
• Primary completion: 2007-10-01
• Completion: 2012-10-01
• First posted: 2008-01-30
• Last updated: 2019-02-11

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated device study