A Prospective Clinical Study On A Total Hip Resurfacing System

May 15, 2014 updated by: Walter van der Weegen, St. Anna Ziekenhuis, Geldrop, Netherlands
This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

298

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Geldrop, Netherlands
        • Knowledge Center for Orthopedic Surgery, St. Anna hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ReCap
ReCap Total Hip Resurfacing System
Device: ReCap Total Hip Resurfacing System
This is a hip resurfacing system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Harris Hip Score, Device Revision/Removal, Radiographic Evaluation
Time Frame: 2 years postoperative
2 years postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Complications
Time Frame: Anytime
Anytime

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Anna Ziekenhuis, Geldrop, Netherlands

Investigators

  • Principal Investigator: H J Hoekstra, MD, St. Anna hospital, Geldrop
  • Principal Investigator: T Sybesma, PhD, St. Anna hospital, Geldrop

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

December 23, 2007

First Submitted That Met QC Criteria

January 16, 2008

First Posted (Estimate)

January 29, 2008

Study Record Updates

Last Update Posted (Estimate)

May 16, 2014

Last Update Submitted That Met QC Criteria

May 15, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EU-6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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