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A Prospective Clinical Study On A Total Hip Resurfacing System

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ClinicalTrials.gov Identifier: NCT00603395
Recruitment Status : Completed
First Posted : January 29, 2008
Last Update Posted : May 16, 2014
Sponsor:
Information provided by (Responsible Party):
Walter van der Weegen, St. Anna Ziekenhuis, Geldrop, Netherlands

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

Condition or disease Intervention/treatment Phase
Arthritis Avascular Necrosis Device: ReCap Total Hip Resurfacing System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 298 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Clinical Study On A Total Hip Resurfacing System
Study Start Date : September 2004
Actual Primary Completion Date : September 2012
Actual Study Completion Date : May 2014

Arm Intervention/treatment
ReCap
ReCap Total Hip Resurfacing System
Device: ReCap Total Hip Resurfacing System
This is a hip resurfacing system.




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

Secondary Outcome Measures :
  1. Complications [ Time Frame: Anytime ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

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

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 Posted: January 29, 2008    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Necrosis
Pathologic Processes