ROCC Knee Data Collection

Arthritis of Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00758901
• Other study ID #: BMET FR 03
• Status: Terminated
• Phase: N/A
• First received: September 23, 2008
• Last updated: March 9, 2017
• Start date: November 2003
• Est. completion date: December 2010

Study information

• Verified date: March 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis of Knee

Intervention

Device:
• Knee Replacement (with ROCC Knee prosthesis)
Knee Replacement (with ROCC Knee prosthesis)

Locations

Country	Name	City	State
Austria	A. ö Landeskrankenhaus Gmunden	Gmunden
France	Clinique des Fontaines	Meulin
Spain	Hospital Torrecardenas	Almeria

Sponsors (2)

Lead Sponsor	Collaborator
Zimmer Biomet	Biomet France SARL

Countries where clinical trial is conducted

Austria,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Knee Score		3 months, 1yr, 2yr, 3yr, 4yr and 5 yr
Secondary	Complication		Any time
Secondary	Patient Satisfaction		3 months, 1yr, 2yr, 3yr, 4yr and 5 yr