ROCC Knee Data Collection

March 9, 2017 updated by: Zimmer Biomet

A Prospective, Multicentre Study Evaluating the Clinical Performance of the ROCC Knee Prosthesis

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Gmunden, Austria
        • A. ö Landeskrankenhaus Gmunden
  • France
      • Meulin, France
        • Clinique des Fontaines
  • Spain
      • Almeria, Spain
        • Hospital Torrecardenas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
American Knee Score
Time Frame: 3 months, 1yr, 2yr, 3yr, 4yr and 5 yr
3 months, 1yr, 2yr, 3yr, 4yr and 5 yr

Secondary Outcome Measures

Outcome Measure
Time Frame
Complication
Time Frame: Any time
Any time
Patient Satisfaction
Time Frame: 3 months, 1yr, 2yr, 3yr, 4yr and 5 yr
3 months, 1yr, 2yr, 3yr, 4yr and 5 yr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Collaborators

Biomet France SARL

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 23, 2008

First Submitted That Met QC Criteria

September 23, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Actual)

March 10, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMET FR 03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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