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ROCC Knee Data Collection

Sponsor
Zimmer Biomet (Industry)
Overall Status
Terminated
CT.gov ID
NCT00758901
Collaborator
Biomet France SARL (Industry)
200
Enrollment
3
Locations
85
Duration (Months)
66.7
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This observational study intends to collect efficacy and safety data on ROCC Knee system.

Condition or Disease Intervention/Treatment Phase
  • Device: Knee Replacement (with 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

Study Design

Study Type:
Observational
Actual Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective, Multicentre Study Evaluating the Clinical Performance of the ROCC Knee Prosthesis
Study Start Date :
Nov 1, 2003
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • ROCC Knee prosthesis

    		•

    Outcome Measures

    Primary Outcome Measures

    1. American Knee Score [3 months, 1yr, 2yr, 3yr, 4yr and 5 yr]

    Secondary Outcome Measures

    1. Complication [Any time]

    2. Patient Satisfaction [3 months, 1yr, 2yr, 3yr, 4yr and 5 yr]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 A. ö Landeskrankenhaus Gmunden Gmunden Austria
    2 Clinique des Fontaines Meulin France
    3 Hospital Torrecardenas Almeria Spain

    Sponsors and Collaborators

    • Zimmer Biomet
    • Biomet France SARL

    Investigators

    • Principal Investigator: Michel BERCOVY, MD, Clinique des Fontaines

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zimmer Biomet
    ClinicalTrials.gov Identifier:
    NCT00758901
    Other Study ID Numbers:
    • BMET FR 03
    First Posted:
    Sep 25, 2008
    Last Update Posted:
    Mar 10, 2017
    Last Verified:
    Mar 1, 2017
    Additional relevant MeSH terms:
    Arthritis

    Study Results

    No Results Posted as of Mar 10, 2017