Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
754 participants
INTERVENTIONAL
2000-05-31
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PFC Sigma Fixed Bearing PCL Sacrificed
PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed
P.F.C Sigma Fixed Bearing total knee system
Orthopaedic implant for total knee replacement
PFC Sigma RP PCL Sacrificed
PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed
P.F.C Sigma RP Mobile Bearing knee system
Orthopaedic implant for total knee replacement
PFC Sigma Fixed Bearing PCL Retained
PFC Sigma Fixed Bearing Total Knee System with PCL Retained
P.F.C Sigma Fixed Bearing total knee system
Orthopaedic implant for total knee replacement
PFC Sigma RP PCL Retained
PFC Sigma Rotating Platform Total Knee System with PCL Retained
P.F.C Sigma RP Mobile Bearing knee system
Orthopaedic implant for total knee replacement
Interventions
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P.F.C Sigma Fixed Bearing total knee system
Orthopaedic implant for total knee replacement
P.F.C Sigma RP Mobile Bearing knee system
Orthopaedic implant for total knee replacement
Eligibility Criteria
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Inclusion Criteria
2. Age - there are no restrictions relating to age of the patient. The patient's age must be considered suitable by the clinical investigator for a bi-compartmental or tri-compartmental knee arthroplasty using either of the two systems available in the evaluation.
3. Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
4. Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.
5. Subjects who require a bi-compartmental or tri-compartmental knee arthroplasty for primary surgical management of idiopathic osteoarthritis.
6. Patients who in the opinion of the Clinical Investigator are considered to be suitable for treatment with a fixed or mobile bearing knee system and who are suitable for patella resurfacing.
Exclusion Criteria
2. Patients who require revision total knee arthroplasty surgery.
3. Patients with any tibial deformity requiring tibial component augmentation.
4. Patients whom, in the opinion of the Clinical Investigator, require a constrained prosthesis.
5. Patients with Rheumatoid Arthritis.
6. Patients with a pathology which, in the opinion of the Clinical Investigator, will adversely affect healing.
7. Patients with other disorders which, in the opinion of the Clinical Investigator, will / could impair rehabilitation.
8. Contra-indications for use of the device, as detailed in the package insert.
9. Women who are pregnant.
10. Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
11. Subjects who are currently involved in another clinical study with an investigational product.
12. Subjects who are currently involved in any injury litigation claims.
18 Years
ALL
No
Sponsors
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DePuy International
INDUSTRY
Responsible Party
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Locations
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Glasgow Royal Infirmary
Glasgow, , United Kingdom
Glasgow Western Infirmary
Glasgow, , United Kingdom
Northampton General Hospital
Northampton, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Countries
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Other Identifiers
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CT 9923
Identifier Type: -
Identifier Source: org_study_id
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