Total Knee Replacement With the ROCC Knee

Rheumatoid Arthritis Clinical Trial

Official title:

Prospective Study of Total Knee Replacement With the ROCC Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02127619
• Other study ID #: 602-ROCC
• Status: Completed
• Phase: N/A
• First received: April 25, 2014
• Last updated: April 28, 2014
• Start date: January 2001
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Bercovy, Michel, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Conseil National de l'Ordre des Médecins
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 2014
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 42 Years to 90 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Device:
• Total knee replacement with the ROCC® knee prosthesis
replacement of an osteoarthritic knee with a total knee prosthesis operation may be for a single knee ( unilateral) or both knees of a patient ( bilateral)

Locations

Country	Name	City	State
France	Clinique Les Fontaines	Melun

Sponsors (1)

Lead Sponsor	Collaborator
Bercovy, Michel, M.D.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	patient satisfaction with the Forgotten Joint Score	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	No
Other	positioning and quality of the fixation of a total knee replacement		minimum 5 years after surgery	No
Primary	locomotor function with the Knee society score		at a minimum of 5 years after surgery	No
Secondary	physical and sports activities with the UCLA activity score		at last follow-up examination, with minimum of 5 years after surgery	No
Secondary	clinical status with the Oxford Knee Score		before surgery	No
Secondary	clinical status with the Oxford knee score		at last follow-up examination, with minimum of 5 years after surgery	No
Secondary	WOMAC ARTHRITIS INDEX		before surgery	No
Secondary	WOMAC ARTHRITIS INDEX		at last follow-up examination, with minimum of 5 years after surgery	No