- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02127619
Total Knee Replacement With the ROCC Knee
April 28, 2014 updated by: Dr Bercovy, Bercovy, Michel, M.D.
Prospective Study of Total Knee Replacement With the ROCC Knee
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Melun, France, 77000
- Clinique les Fontaines
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
42 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
locomotor function with the Knee society score
Time Frame: at a minimum of 5 years after surgery
|
at a minimum of 5 years after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
physical and sports activities with the UCLA activity score
Time Frame: at last follow-up examination, with minimum of 5 years after surgery
|
at last follow-up examination, with minimum of 5 years after surgery
|
clinical status with the Oxford Knee Score
Time Frame: before surgery
|
before surgery
|
clinical status with the Oxford knee score
Time Frame: at last follow-up examination, with minimum of 5 years after surgery
|
at last follow-up examination, with minimum of 5 years after surgery
|
WOMAC ARTHRITIS INDEX
Time Frame: before surgery
|
before surgery
|
WOMAC ARTHRITIS INDEX
Time Frame: at last follow-up examination, with minimum of 5 years after surgery
|
at last follow-up examination, with minimum of 5 years after surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
patient satisfaction with the Forgotten Joint Score
Time Frame: at last follow-up examination, with minimum of 5 years after surgery
|
this score asseses the perfection on patient's point of view for a total knee replacement
|
at last follow-up examination, with minimum of 5 years after surgery
|
positioning and quality of the fixation of a total knee replacement
Time Frame: minimum 5 years after surgery
|
minimum 5 years after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michel Bercovy, md, Clinique Les Fontaines- 77000 - Melun- FRANCE
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2001
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
April 25, 2014
First Submitted That Met QC Criteria
April 28, 2014
First Posted (Estimate)
May 1, 2014
Study Record Updates
Last Update Posted (Estimate)
May 1, 2014
Last Update Submitted That Met QC Criteria
April 28, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 602-ROCC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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