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A Prospective Clinical Study On A Total Hip Resurfacing System

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
St. Anna Ziekenhuis, Geldrop, Netherlands
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00603395
First received: December 23, 2007
Last updated: February 11, 2012
Last verified: February 2012
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
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 Biomet, Inc.:

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

Secondary Outcome Measures:
  • Complications [ Time Frame: Anytime ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: September 2004
Estimated Study Completion Date: September 2017
Estimated 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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603395

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

No publications provided by Biomet, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Biomet, Inc.
ClinicalTrials.gov Identifier: NCT00603395     History of Changes
Other Study ID Numbers: EU-6
Study First Received: December 23, 2007
Last Updated: February 11, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Arthritis
Necrosis
Osteonecrosis
Joint Diseases
 Musculoskeletal Diseases
Pathologic Processes
Bone Diseases

ClinicalTrials.gov processed this record on June 18, 2013