Total Knee Replacement With the ROCC Knee

NCT ID: NCT02127619

Last Updated: 2014-05-01

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

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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)

Intervention Type DEVICE

Other Intervention Names

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Total knee arthroplasty Total knee prosthesis

Eligibility Criteria

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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
Minimum Eligible Age

42 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bercovy, Michel, M.D.

INDIV

Sponsor Role lead

Responsible Party

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Dr Bercovy

Orthopedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michel Bercovy, md

Role: PRINCIPAL_INVESTIGATOR

Clinique Les Fontaines- 77000 - Melun- FRANCE

Locations

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Clinique Les Fontaines

Melun, , France

Site Status

Countries

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France

Other Identifiers

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602-ROCC

Identifier Type: -

Identifier Source: org_study_id

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