Status:
TERMINATED
PFC Sigma Fixed and Mobile Knee Study
Lead Sponsor:
DePuy International
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary objective of this investigation is to evaluate the performance (in terms of post-operative active range of motion at one year) of the P.F.C. Sigma and P.F.C. Sigma Rotating Platform total ...
Detailed Description
The secondary objectives of this investigation are:To evaluate the performance of the P.F.C. Sigma and P.F.C. Sigma Rotating Platform total knee systems in clinical practice. To evaluate the impact of...
Eligibility Criteria
Inclusion
- Male or female subjects may be recruited to the evaluation.
- 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.
- Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
- 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.
- Subjects who require a bi-compartmental or tri-compartmental knee arthroplasty for primary surgical management of idiopathic osteoarthritis.
- 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
- Patients who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
- Patients who require revision total knee arthroplasty surgery.
- Patients with any tibial deformity requiring tibial component augmentation.
- Patients whom, in the opinion of the Clinical Investigator, require a constrained prosthesis.
- Patients with Rheumatoid Arthritis.
- Patients with a pathology which, in the opinion of the Clinical Investigator, will adversely affect healing.
- Patients with other disorders which, in the opinion of the Clinical Investigator, will / could impair rehabilitation.
- Contra-indications for use of the device, as detailed in the package insert.
- Women who are pregnant.
- Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.
- Subjects who are currently involved in another clinical study with an investigational product.
- Subjects who are currently involved in any injury litigation claims.
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
754 Patients enrolled
Trial Details
Trial ID
NCT00208325
Start Date
May 1 2000
End Date
September 1 2010
Last Update
September 13 2016
Active Locations (4)
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1
Glasgow Royal Infirmary
Glasgow, United Kingdom
2
Glasgow Western Infirmary
Glasgow, United Kingdom
3
Northampton General Hospital
Northampton, United Kingdom
4
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1LB