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ROCC Knee Data Collection

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ClinicalTrials.gov Identifier: NCT00758901
Recruitment Status : Terminated (Site Decision)
First Posted : September 25, 2008
Last Update Posted : March 10, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This observational study intends to collect efficacy and safety data on ROCC Knee system.

Condition or disease Intervention/treatment
Arthritis of Knee Device: Knee Replacement (with ROCC Knee prosthesis)

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

Study Design

Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicentre Study Evaluating the Clinical Performance of the ROCC Knee Prosthesis
Study Start Date : November 2003
Primary Completion Date : December 2010
Study Completion Date : December 2010
Groups and Cohorts

Group/Cohort Intervention/treatment
1 ROCC Knee prosthesis
Consecutive series of patients with ROCC Knee prosthesis.
Device: Knee Replacement (with ROCC Knee prosthesis)
Knee Replacement (with ROCC Knee prosthesis)
Other Name: ROCC Knee prosthesis


Outcome Measures

Primary Outcome Measures :
  1. American Knee Score [ Time Frame: 3 months, 1yr, 2yr, 3yr, 4yr and 5 yr ]

Secondary Outcome Measures :
  1. Complication [ Time Frame: Any time ]
  2. Patient Satisfaction [ Time Frame: 3 months, 1yr, 2yr, 3yr, 4yr and 5 yr ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive series of patients received ROCC Knee prostheses for osteoarthritis, rheumatoid arthritis and bone necrosis affecting two knee compartments, correction of genu varus, genu valgus or post-traumatic deformities, sequelae of prior procedures
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00758901


Locations
Austria
A. ö Landeskrankenhaus Gmunden
Gmunden, Austria
France
Clinique des Fontaines
Meulin, France
Spain
Hospital Torrecardenas
Almeria, Spain
Sponsors and Collaborators
Zimmer Biomet
Biomet France SARL
Investigators
Principal Investigator: Michel BERCOVY, MD Clinique des Fontaines
More Information

Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT00758901     History of Changes
Other Study ID Numbers: BMET FR 03
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017