Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

ROCC Knee Data Collection

This study has been terminated.
(Site Decision)
Sponsor:
Collaborator:
Biomet France SARL
Information provided by (Responsible Party):
Zimmer Biomet
ClinicalTrials.gov Identifier:
NCT00758901
First received: September 23, 2008
Last updated: March 9, 2017
Last verified: March 2017
  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

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
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 ClinicalTrials.gov identifier: 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
Study First Received: September 23, 2008
Last Updated: March 9, 2017

ClinicalTrials.gov processed this record on April 28, 2017