Clinical trial: PFC Sigma Fixed and Mobile Knee Study (NCT00208325)

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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? 1