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ROCC Knee Data Collection

This study has been terminated.
(Site Decision)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00758901
First Posted: September 25, 2008
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Biomet France SARL
Information provided by (Responsible Party):
Zimmer Biomet
  Purpose
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 Zimmer Biomet:

Primary Outcome Measures:
  • American Knee Score [ Time Frame: 3 months, 1yr, 2yr, 3yr, 4yr and 5 yr ]

Secondary Outcome Measures:
  • Complication [ Time Frame: Any time ]
  • Patient Satisfaction [ Time Frame: 3 months, 1yr, 2yr, 3yr, 4yr and 5 yr ]

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • bone necrosis affecting two knee compartments,
  • correction of genu varus, genu valgus or post-traumatic deformities,
  • sequelae of prior procedures.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00758901


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

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00758901     History of Changes
Other Study ID Numbers: BMET FR 03
First Submitted: September 23, 2008
First Posted: September 25, 2008
Last Update Posted: March 10, 2017
Last Verified: March 2017