PFC Sigma Fixed and Mobile Knee Study

DePuy Synthes

Status and phase: Terminated; Phase 4

Conditions: Osteoarthritis, Knee

Treatments: Device: P.F.C Sigma RP Mobile Bearing knee system; Device: P.F.C Sigma Fixed Bearing total knee system

Study type: Interventional

Funder types: Industry

Identifiers

NCT00208325

CT 9923

Details and patient eligibility

About

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 knee systems in clinical practice.

Full 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 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.

Enrollment: 754 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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754 participants in 4 patient groups

PFC Sigma Fixed Bearing PCL Sacrificed

Other group

Description:

PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed

Treatment:

Device: P.F.C Sigma Fixed Bearing total knee system

PFC Sigma RP PCL Sacrificed

Active Comparator group

Description:

PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed

Treatment:

Device: P.F.C Sigma RP Mobile Bearing knee system

PFC Sigma Fixed Bearing PCL Retained

Other group

Description:

PFC Sigma Fixed Bearing Total Knee System with PCL Retained

Treatment:

Device: P.F.C Sigma Fixed Bearing total knee system

PFC Sigma RP PCL Retained

Active Comparator group

Description:

PFC Sigma Rotating Platform Total Knee System with PCL Retained

Treatment:

Device: P.F.C Sigma RP Mobile Bearing knee system