PFC Sigma Fixed and Mobile Knee Study

Launched by DEPUY INTERNATIONAL · Sep 13, 2005

Keywords

ClinConnect Summary

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 patellar resurfacing on the performance of the P.F.C. Sigma and the P.F.C. Sigma Rotating Platform total knee systems. To evaluate the impact of Posterior Cruciate Ligament (PCL) sacrifice or retention on the performance of the P.F.C. Sigma and the P.F.C. Sigma Rotating Platform total knee systems.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female subjects may be recruited to the evaluation.
• • 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:
• • 1. Patients who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
• • 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.