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Sponsored by: |
Biomet, Inc. |
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Information provided by: | Biomet, Inc. |
ClinicalTrials.gov Identifier: | NCT00758901 |
This observational study intends to collect efficacy and safety data on ROCC Knee system.
Condition | Intervention |
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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 |
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 |
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1
Consecutive series of patients with ROCC Knee prosthesis.
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Device: Knee Replacement (with ROCC Knee prosthesis)
Knee Replacement (with ROCC Knee prosthesis)
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The ROCC® prosthesis is a rotating platform with:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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
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.
Contact: Gregoire Edorh | + 33 (0)4 75 75 91 19 | gregoire.edorh@biomet.com |
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 |
Responsible Party: | Biomet France ( Gregoire Edorh, Clinical Manager ) |
Study ID Numbers: | BMET FR 03 |
Study First Received: | September 23, 2008 |
Last Updated: | June 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00758901 History of Changes |
Health Authority: | France: Institutional Ethical Committee |