ROCC Knee Data Collection - Full Text View

Sponsor:	Biomet, Inc.
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00758901

Purpose

This observational study intends to collect efficacy and safety data on ROCC Knee system.

Condition	Intervention
Arthroplasty, Replacement, Knee	Device: Knee Replacement (with ROCC Knee prosthesis)

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	A Prospective, Multicentre Study Evaluating the Clinical Performance of the ROCC Knee Prosthesis

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement

U.S. FDA Resources

Further study details as provided by Biomet, Inc.:

Primary Outcome Measures:

American Knee Score [ Time Frame: 3 months, 1yr, 2yr, 3yr, 4yr and 5 yr ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Complication [ Time Frame: Any time ] [ Designated as safety issue: Yes ]
Patient Satisfaction [ Time Frame: 3 months, 1yr, 2yr, 3yr, 4yr and 5 yr ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	November 2003
Estimated Study Completion Date:	July 2015
Estimated Primary Completion Date:	July 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Consecutive series of patients with ROCC Knee prosthesis.	Device: Knee Replacement (with ROCC Knee prosthesis) Knee Replacement (with ROCC Knee prosthesis)

Detailed Description:

The ROCC® prosthesis is a rotating platform with:

Highly congruent surface contact,
NON CONSTRAINED kinematics allowing posterior roll back until 110° then anterior in hyperflexion like a normal knee
Allowing asymmetric movement

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Consecutive series of patients received ROCC Knee prostheses for osteoarthritis, rheumatoid arthritis and bone necrosis affecting two knee compartments, correction of genu varus, genu valgus or post-traumatic deformities, sequelae of prior procedures

Criteria

Patients suitable for Knee Replacement for osteoarthritis, rheumatoid arthritis and bone necrosis affecting two knee compartments, correction of genu varus, genu valgus or post-traumatic deformities, sequelae of prior procedures.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758901

Contacts

Contact: Gregoire Edorh

+ 33 (0)4 75 75 91 19

gregoire.edorh@biomet.com

Locations

Austria
A. ö Landeskrankenhaus Gmunden	Active, not recruiting
Gmunden, Austria
France
Clinique des Fontaines	Recruiting
Meulin, France
Contact: BERCOVY, MD 01.60.56.40.28
Spain
Hospital Torrecardenas	Active, not recruiting
Almeria, Spain

Sponsors and Collaborators

Biomet, Inc.

More Information

No publications provided

Responsible Party:	Biomet France ( Gregoire Edorh, Clinical Manager )
Study ID Numbers:	BMET FR 03
Study First Received:	September 23, 2008
Last Updated:	December 11, 2009
ClinicalTrials.gov Identifier:	NCT00758901 History of Changes
Health Authority:	France: French Data Protection Authority

ClinicalTrials.gov processed this record on February 08, 2010