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A Prospective Clinical Study On A Total Hip Resurfacing System

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00603395
First Posted: January 29, 2008
Last Update Posted: May 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Walter van der Weegen, St. Anna Ziekenhuis, Geldrop, Netherlands
  Purpose
This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.

Condition Intervention
Arthritis Avascular Necrosis Device: ReCap Total Hip Resurfacing System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Clinical Study On A Total Hip Resurfacing System

Further study details as provided by Walter van der Weegen, St. Anna Ziekenhuis, Geldrop, Netherlands:

Primary Outcome Measures:
  • Harris Hip Score, Device Revision/Removal, Radiographic Evaluation [ Time Frame: 2 years postoperative ]

Secondary Outcome Measures:
  • Complications [ Time Frame: Anytime ]

Enrollment: 298
Study Start Date: September 2004
Study Completion Date: May 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ReCap
ReCap Total Hip Resurfacing System
Device: ReCap Total Hip Resurfacing System
This is a hip resurfacing system.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00603395


Locations
Netherlands
Knowledge Center for Orthopedic Surgery, St. Anna hospital
Geldrop, Netherlands
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Walter van der Weegen, Researcher, St. Anna Ziekenhuis, Geldrop, Netherlands
ClinicalTrials.gov Identifier: NCT00603395     History of Changes
Other Study ID Numbers: EU-6
First Submitted: December 23, 2007
First Posted: January 29, 2008
Last Update Posted: May 16, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Necrosis
Pathologic Processes