A Prospective Clinical Study On A Total Hip Resurfacing System

This study is currently recruiting participants.

Verified by Biomet, Inc., February 2010

First Received: December 23, 2007 Last Updated: February 3, 2010 History of Changes

Sponsor:	Biomet, Inc.
Collaborator:	Knowledge Center for Orthopedic Surgery, St. Anna Hospital, Geldrop, Netherlands
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00603395

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:	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:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603395

Contacts

Contact: Walter van der Weegen

06-34282788

Locations

Netherlands
Knowledge Center for Orthopedic Surgery, St. Anna hospital	Recruiting
Geldrop, Netherlands
Contact: Walter van der Weegen 06-34282788 w.vander.weegen@st-anna.nl

Sponsors and Collaborators

Biomet, Inc.

Knowledge Center for Orthopedic Surgery, St. Anna Hospital, 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

Responsible Party:	Biomet Orthopedics, Inc. ( Tracy Johnson, Director of Clinical and Regulatory Affairs )
Study ID Numbers:	EU-6
Study First Received:	December 23, 2007
Last Updated:	February 3, 2010
ClinicalTrials.gov Identifier:	NCT00603395 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:

Necrosis
Pathologic Processes
Musculoskeletal Diseases
Osteonecrosis

Joint Diseases
Arthritis
Bone Diseases

ClinicalTrials.gov processed this record on February 08, 2010