Status:
TERMINATED
A Study to Compare the Press Fit Condylar (P.F.C.) Sigma Rotating-platform High-flexion (RP-F) Versus the Press Fit Condylar (P.F.C.) Sigma Rotating-platform (RP) Knee Implants
Lead Sponsor:
DePuy International
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
45-75 years
Phase:
PHASE4
Brief Summary
The main objective of this study is to determine if the P.F.C. Sigma RP-F Knee delivers a greater post-operative range of motion (ROM) compared with the P.F.C. Sigma RP Knee in primary TKA. The secon...
Detailed Description
Primary Outcome: Change from pre-operative range of motion at 1 year between patients receiving P.F.C. Sigma RP vs P.F.C. Sigma RP-F Secondary endpoints: Comparative evaluation of any post-operative ...
Eligibility Criteria
Inclusion
- Male or female subjects, aged between 45 and 75 years inclusive.
- Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
- Subjects who present with osteoarthritis that in the opinion of the clinical investigator requires a primary total knee arthroplasty.
- Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with either the P.F.C Sigma RP-F or the P.F.C Sigma RP knee, according to the indications specified in the package insert leaflet.
- Subjects who have authorised the transfer of his/her pseudonymised information to DePuy.
Exclusion
- Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
- Female subjects who are pregnant or lactating.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
- Subjects who have participated in a clinical investigation with an investigational product in the last month( 30 days).
- Subjects who are currently involved in any injury litigation claims.
- Subjects with a known history of poor compliance to medical treatment.
- Subjects who have previously had an osteotomy or significant surgery in the affected knee.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00733369
Start Date
November 1 2007
End Date
August 1 2014
Last Update
September 13 2016
Active Locations (2)
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1
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
2
Arrowe Park Hospital
Metropolitan Borough of Wirral, Mersyside, United Kingdom