Text Size

ROCC Knee Data Collection

This study has been terminated.
(Site Decision)
Sponsor:
Collaborator:
Biomet France SARL
Information provided by (Responsible Party):
Biomet, Inc.
ClinicalTrials.gov Identifier:
NCT00758901
First received: September 23, 2008
Last updated: December 2, 2011
Last verified: December 2011
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years and older
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

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
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
Biomet, Inc.
Biomet France SARL
Investigators
Principal Investigator: Michel BERCOVY, MD Clinique des Fontaines
  More Information

No publications provided

Responsible Party: Biomet, Inc.
ClinicalTrials.gov 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

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 23, 2013