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A Prospective Clinical Study On A Total Hip Resurfacing System

This study has been completed.
Information provided by (Responsible Party):
Walter van der Weegen, St. Anna Ziekenhuis, Geldrop, Netherlands Identifier:
First received: December 23, 2007
Last updated: May 15, 2014
Last verified: May 2014
This prospective clinical study is to demonstrate the efficacy and safety of ReCap Total Hip Resurfacing System.

Condition Intervention
Avascular Necrosis
Device: ReCap Total Hip Resurfacing System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Clinical Study On A Total Hip Resurfacing System

Further study details as provided by 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 Total Hip Resurfacing System
Device: ReCap Total Hip Resurfacing System
This is a hip resurfacing system.


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00603395

Knowledge Center for Orthopedic Surgery, St. Anna hospital
Geldrop, Netherlands
Sponsors and Collaborators
St. Anna Ziekenhuis, Geldrop, Netherlands
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 Identifier (NCT Number):
Responsible Party: Walter van der Weegen, Researcher, St. Anna Ziekenhuis, Geldrop, Netherlands Identifier: NCT00603395     History of Changes
Other Study ID Numbers: EU-6
Study First Received: December 23, 2007
Last Updated: May 15, 2014

Additional relevant MeSH terms:
Pathologic Processes processed this record on May 22, 2017