A Prospective Clinical Study On A Total Hip Resurfacing System

Not Applicable

Completed

• Conditions: Arthritis; Avascular Necrosis
• Interventions: Device: ReCap Total Hip Resurfacing System

• Registration Number: NCT00603395
• Lead Sponsor: St. Anna Ziekenhuis, Geldrop, Netherlands

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2007-12-23
• Study First Submitted QC: 2008-01-16
• Study First Posted: 2008-01-29
• Primary Completion: 2012-09
• Status Verified: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-15
• Last Update Posted: 2014-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 298

Inclusion Criteria

• intended for skeletally mature individuals undergoing primary surgery as a result of hip degenerative joint disease, or any composite diagnoses, including:

  • Osteoarthritis
  • Avascular necrosis
  • Traumatic arthritis
  • Legg Perthes
  • Rheumatoid arthritis

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ReCap	ReCap Total Hip Resurfacing System	ReCap Total Hip Resurfacing System

Primary Outcome Measures

Name	Time	Method
Harris Hip Score, Device Revision/Removal, Radiographic Evaluation	2 years postoperative

Secondary Outcome Measures

Name	Time	Method
Complications	Anytime

Trial Locations

Locations (1)

Knowledge Center for Orthopedic Surgery, St. Anna hospital; 🇳🇱 Geldrop, Netherlands