A Prospective Clinical Study On A Total Hip Resurfacing System

This study is ongoing, but not recruiting participants.

First Received on December 23, 2007. Last Updated on June 7, 2011 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:	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

Resource links provided by NLM:

MedlinePlus related topics: Osteonecrosis

U.S. FDA Resources

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

Locations

Netherlands
Knowledge Center for Orthopedic Surgery, St. Anna hospital
Geldrop, Netherlands

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:	Keli Hankee or Russell Schenck, Biomet Orthopedics, Inc.
ClinicalTrials.gov Identifier:	NCT00603395 History of Changes
Other Study ID Numbers:	EU-6
Study First Received:	December 23, 2007
Last Updated:	June 7, 2011
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 February 09, 2012