A Prospective Clinical Study On A Total Hip Resurfacing System

This study is currently recruiting participants.

Verified by Biomet, Inc., December 2009

First Received: December 23, 2007 Last Updated: December 8, 2009 History of Changes

Sponsor:	Biomet, Inc.
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00604734

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:	Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Prospective Clinical Study On A Total Hip Resurfacing System

Resource links provided by NLM:

MedlinePlus related topics: Osteonecrosis

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:

Estimated Enrollment:	500
Study Start Date:	October 2004
Estimated Study Completion Date:	October 2017
Estimated Primary Completion Date:	October 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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604734

Contacts

Contact: Fabienne Lambert

32-3 870 65 77

Locations

Belgium
Az Nikolaas Campus Sint Niklaas	Recruiting
Sint Niklaas, Belgium
Contact: Fabienne Lambert 32-3 870 65 77 fabienne.lambert@biometeurope.com

Sponsors and Collaborators

Biomet, Inc.

Investigators

Principal Investigator:	H P Delport, MD	AZ NIKOLAAS CAMPUS SINT NIKLAAS
Principal Investigator:	Jo De Schepper, MD	AZ NIKOLAAS CAMPUS SINT NIKLAAS

More Information

No publications provided

Responsible Party:	Biomet Orthopedics, Inc. ( Tracy Johnson, Director of Clinical and Regulatory Affairs )
Study ID Numbers:	EU-8
Study First Received:	December 23, 2007
Last Updated:	December 8, 2009
ClinicalTrials.gov Identifier:	NCT00604734 History of Changes
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment

Additional relevant MeSH terms:

Necrosis
Pathologic Processes
Musculoskeletal Diseases
Osteonecrosis

Joint Diseases
Arthritis
Bone Diseases

ClinicalTrials.gov processed this record on February 08, 2010