ROCC Knee Data Collection
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on October 19, 2009 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arthroplasty, Replacement, Knee
Intervention: Knee Replacement (with ROCC Knee prosthesis) (Device)
Phase: N/A
Status: Recruiting
Sponsored by: Biomet, Inc. Overall contact: Gregoire Edorh, Phone: + 33 (0)4 75 75 91 19, Email: gregoire.edorh@biomet.com
Summary
This observational study intends to collect efficacy and safety data on ROCC Knee system.
Clinical Details
Official title: A Prospective, Multicentre Study Evaluating the Clinical Performance of the ROCC Knee Prosthesis
Study design: Cohort, Prospective
Primary outcome: American Knee Score
Secondary outcome: ComplicationPatient Satisfaction
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Gregoire Edorh, Phone: + 33 (0)4 75 75 91 19, Email: gregoire.edorh@biomet.com
A. ö Landeskrankenhaus Gmunden, GMUNDEN, Austria; Active, not recruiting
Clinique des Fontaines, MEULIN, France; Recruiting BERCOVY, MD, Phone: 01.60.56.40.28
Hospital Torrecardenas, ALMERIA, Spain; Active, not recruiting
Additional Information
Starting date: November 2003
Ending date: July 2015
Last updated: June 18, 2009
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