Total Knee Replacement With the ROCC Knee

Not Applicable

Completed

• Conditions: Osteoarthritis; Rheumatoid Arthritis

• Registration Number: NCT02127619
• Lead Sponsor: Bercovy, Michel, M.D.

Brief Summary

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.

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 Timeline

• Study Start: 2001-01
• Primary Completion: 2008-01
• Study Completion: 2014-03
• Status Verified: 2014-04
• Study First Submitted: 2014-04-25
• Study First Submitted QC: 2014-04-28
• Last Update Submitted: 2014-04-28
• Study First Posted: 2014-05-01
• Last Update Posted: 2014-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
locomotor function with the Knee society score	at a minimum of 5 years after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinique Les Fontaines; 🇫🇷 Melun, France