PFC Sigma Fixed and Mobile Knee Study - Full Text View

Sponsored by:	DePuy International
Information provided by:	DePuy International
ClinicalTrials.gov Identifier:	NCT00208325

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis, Knee	Device: P.F.C Sigma Fixed Bearing total knee system Device: P.F.C Sigma RP Mobile Bearing knee system	Phase IV

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clinical Evaluation of the P.F.C. Sigma (Fixed Bearing) and P.F.C. Sigma RP (Mobile Bearing) Total Knee Systems

Further study details as provided by DePuy International:

Primary Outcome Measures:

Active range of knee motion [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Annual joint survival [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	684
Study Start Date:	May 1999
Estimated Study Completion Date:	July 2022
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Fixed bearing	Device: P.F.C Sigma Fixed Bearing total knee system Orthopaedic implant for total knee replacement
2: Experimental Mobile bearing	Device: P.F.C Sigma RP Mobile Bearing knee system Orthopaedic implant for total knee replacement

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208325

Locations

United Kingdom
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1LB
Glasgow Royal Infirmary
Glasgow, United Kingdom
Glasgow Western Infirmary
Glasgow, United Kingdom
Northampton General Hospital
Northampton, United Kingdom

Sponsors and Collaborators

DePuy International

Investigators

Study Director:	Michael Borroff, BSc, MSc	DePuy International ltd
Principal Investigator:	Mr Peter James, FRCS	Nottingham City Hospital

More Information

Responsible Party:	DePuy International Ltd ( Mick Borroff )
Study ID Numbers:	CT 9923
Study First Received:	September 13, 2005
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00208325
Health Authority:	United Kingdom: Research Ethics Committee

Study placed in the following topic categories:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 16, 2009