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

December 23, 2007
February 11, 2012
September 2004
September 2012   (final data collection date for primary outcome measure)
Harris Hip Score, Device Revision/Removal, Radiographic Evaluation [ Time Frame: 2 years postoperative ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00603395 on ClinicalTrials.gov Archive Site
Complications [ Time Frame: Anytime ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Prospective Clinical Study On A Total Hip Resurfacing System
A Prospective Clinical Study On A Total Hip Resurfacing System

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

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Arthritis
  • Avascular Necrosis
Device: ReCap Total Hip Resurfacing System
This is a hip resurfacing system.
ReCap
ReCap Total Hip Resurfacing System
Intervention: Device: ReCap Total Hip Resurfacing System
van der Weegen W, Hoekstra HJ, Sijbesma T, Austen S, Poolman RW. Hip resurfacing in a district general hospital: 6-year clinical results using the ReCap hip resurfacing system. BMC Musculoskelet Disord. 2012 Dec 13;13:247. doi: 10.1186/1471-2474-13-247.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
September 2017
September 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00603395
EU-6
No
Biomet, Inc.
Biomet, Inc.
St. Anna Ziekenhuis, Geldrop, Netherlands
Principal Investigator: H J Hoekstra, MD St. Anna hospital, Geldrop
Principal Investigator: T Sybesma, PhD St. Anna hospital, Geldrop
Biomet, Inc.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP