A Prospective Clinical Study On A Total Hip Resurfacing System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Walter van der Weegen, St. Anna Ziekenhuis, Geldrop, Netherlands
ClinicalTrials.gov Identifier:
NCT00603395
First received: December 23, 2007
Last updated: May 15, 2014
Last verified: May 2014
  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 St. Anna Ziekenhuis, Geldrop, Netherlands:

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 ]

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

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
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 ClinicalTrials.gov identifier: 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

No publications provided by St. Anna Ziekenhuis, Geldrop, Netherlands

Additional 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
Study First Received: December 23, 2007
Last Updated: May 15, 2014
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 July 31, 2014