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ROCC Knee Data Collection

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00758901
Enrollment
200
Registered
2008-09-25
Start date
2003-11-30
Completion date
2010-12-31
Last updated
2017-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis of Knee

Brief summary

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

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

Interventions

DEVICEKnee Replacement (with ROCC Knee prosthesis)

Knee Replacement (with ROCC Knee prosthesis)

Sponsors

Biomet France SARL
CollaboratorINDUSTRY
Zimmer Biomet
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
American Knee Score3 months, 1yr, 2yr, 3yr, 4yr and 5 yr

Secondary

MeasureTime frame
ComplicationAny time
Patient Satisfaction3 months, 1yr, 2yr, 3yr, 4yr and 5 yr

Countries

Austria, France, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026