Total Knee Replacement With the ROCC Knee

April 28, 2014 updated by: Dr Bercovy, Bercovy, Michel, M.D.

Prospective Study of Total Knee Replacement With the ROCC Knee

The purpose of this study was to assess the results of a Total Knee prosthesis specifically intended to enhance functional performance , especially in terms of physical and sports activity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Clinical and radiographic results , complications, early post-operative and late functional outcome and survivorship were studied in a continuous prospective series of 500 patients ( 602 knees) managed using the ROCC knee ( BIOMET INC - Warsaw- IND, USA).

A minimum follow-up of 5 years was required.

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

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

  • France
      • Melun, France, 77000
        • Clinique les Fontaines

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

42 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients receiving a total knee

Exclusion Criteria:

  • patients with severe psychiatric, neurologic, cardiologic or locomotor pathology occuring after the total knee replacement

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
locomotor function with the Knee society score
Time Frame: at a minimum of 5 years after surgery
at a minimum of 5 years after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
physical and sports activities with the UCLA activity score
Time Frame: at last follow-up examination, with minimum of 5 years after surgery
at last follow-up examination, with minimum of 5 years after surgery
clinical status with the Oxford Knee Score
Time Frame: before surgery
before surgery
clinical status with the Oxford knee score
Time Frame: at last follow-up examination, with minimum of 5 years after surgery
at last follow-up examination, with minimum of 5 years after surgery
WOMAC ARTHRITIS INDEX
Time Frame: before surgery
before surgery
WOMAC ARTHRITIS INDEX
Time Frame: at last follow-up examination, with minimum of 5 years after surgery
at last follow-up examination, with minimum of 5 years after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction with the Forgotten Joint Score
Time Frame: at last follow-up examination, with minimum of 5 years after surgery
this score asseses the perfection on patient's point of view for a total knee replacement
at last follow-up examination, with minimum of 5 years after surgery
positioning and quality of the fixation of a total knee replacement
Time Frame: minimum 5 years after surgery
minimum 5 years after surgery

Collaborators and Investigators

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

Sponsor

Bercovy, Michel, M.D.

Investigators

  • Principal Investigator: Michel Bercovy, md, Clinique Les Fontaines- 77000 - Melun- FRANCE

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

January 1, 2001

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

April 25, 2014

First Submitted That Met QC Criteria

April 28, 2014

First Posted (Estimate)

May 1, 2014

Study Record Updates

Last Update Posted (Estimate)

May 1, 2014

Last Update Submitted That Met QC Criteria

April 28, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 602-ROCC

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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