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ROCC Knee Data Collection

This study has been terminated.
(Site Decision)
Biomet France SARL
Information provided by (Responsible Party):
Biomet, Inc. Identifier:
First received: September 23, 2008
Last updated: December 2, 2011
Last verified: December 2011
This observational study intends to collect efficacy and safety data on ROCC Knee system.

Condition Intervention
Arthritis of Knee
Device: Knee Replacement (with ROCC Knee prosthesis)

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

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 ]

Enrollment: 200
Study Start Date: November 2003
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 ROCC Knee prosthesis
Consecutive series of patients with ROCC Knee prosthesis.
Device: Knee Replacement (with ROCC Knee prosthesis)
Knee Replacement (with ROCC Knee prosthesis)
Other Name: 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Patients suitable for Knee Replacement for:

  • osteoarthritis,
  • rheumatoid arthritis
  • bone necrosis affecting two knee compartments,
  • correction of genu varus, genu valgus or post-traumatic deformities,
  • sequelae of prior procedures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00758901

A. ö Landeskrankenhaus Gmunden
Gmunden, Austria
Clinique des Fontaines
Meulin, France
Hospital Torrecardenas
Almeria, Spain
Sponsors and Collaborators
Biomet, Inc.
Biomet France SARL
Principal Investigator: Michel BERCOVY, MD Clinique des Fontaines
  More Information

Responsible Party: Biomet, Inc. Identifier: NCT00758901     History of Changes
Other Study ID Numbers: BMET FR 03 
Study First Received: September 23, 2008
Last Updated: December 2, 2011
Health Authority: France: French Data Protection Authority processed this record on October 26, 2016