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NCT00603395 Clinical Trial

A Prospective Clinical Study On A Total Hip Resurfacing System

Arthritis Clinical Trial

Official title:
A Prospective Clinical Study On A Total Hip Resurfacing System

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00603395
Other study ID # EU-6
Secondary ID
Status Completed
Phase N/A
First received December 23, 2007
Last updated May 15, 2014
Start date September 2004
Est. completion date May 2014

Study information
Verified date May 2014
Source St. Anna Ziekenhuis, Geldrop, Netherlands
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 298
Est. completion date May 2014
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• ReCap Total Hip Resurfacing System
This is a hip resurfacing system.

Locations
Country Name City State
Netherlands Knowledge Center for Orthopedic Surgery, St. Anna hospital Geldrop

Sponsors (1)
Lead Sponsor Collaborator
St. Anna Ziekenhuis, Geldrop, Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Harris Hip Score, Device Revision/Removal, Radiographic Evaluation 2 years postoperative Yes
Secondary Complications Anytime Yes
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