ROCC Knee Data Collection

NCT ID: NCT00758901

Last Updated: 2017-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-11-30

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Arthritis of Knee

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1 ROCC Knee prosthesis

Consecutive series of patients with ROCC Knee prosthesis.

Knee Replacement (with ROCC Knee prosthesis)

Intervention Type DEVICE

Knee Replacement (with ROCC Knee prosthesis)

Interventions

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Knee Replacement (with ROCC Knee prosthesis)

Knee Replacement (with ROCC Knee prosthesis)

Intervention Type DEVICE

Other Intervention Names

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ROCC Knee prosthesis

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biomet France SARL

INDUSTRY

Sponsor Role collaborator

Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michel BERCOVY, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique des Fontaines

Locations

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A. ö Landeskrankenhaus Gmunden

Gmunden, , Austria

Site Status

Clinique des Fontaines

Meulin, , France

Site Status

Hospital Torrecardenas

Almería, , Spain

Site Status

Countries

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Austria France Spain

Other Identifiers

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BMET FR 03

Identifier Type: -

Identifier Source: org_study_id

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