Functional outcome of the P.F.C. Sigma® RP-F knee system and the P.F.C. Sigma® knee system: a prospective, randomised controlled trial

South Tees Hospitals NHS Trust (UK)0 sites120 target enrollmentSeptember 12, 2007

Overview

2010 Results article in https://pubmed.ncbi.nlm.nih.gov/19898821/ (added 13/04/2022)

Registry

who.int

Start Date

September 12, 2007

End Date

March 31, 2019

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

South Tees Hospitals NHS Trust (UK)

•1\. Male or female subjects, aged 18 years and older.
•2\. Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.
•3\. 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.
•4\. Subjects who present with idiopathic or posttraumatic osteoarthritis that in the opinion of the clinical investigator requires a primary total knee arthroplasty and who are considered suitable for treatment with P.F.C. Sigma® RP\-F and P.F.C. Sigma® knee systems.
•5\. Subjects, who in the opinion of the Clinical Investigator, are considered to be suitable for treatment with both investigational devices, according to the indications specified in the package insert leaflet.

•1\. Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow\-up in this study.
•2\. Subjects with a Body Mass Index (BMI) \>35\.
•3\. Subjects with a known history of poor compliance to medical treatment.
•4\. Women who are pregnant.
•5\. Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow\-up care or treatment outcomes.
•6\. Subjects involved in Medical\-Legal claims.
•7\. Intra\-operative use of augmentation devices.
•8\. Intra\-operative decision to resurface the patella based on clinical indication.
•9\. Revision of an existing knee implant.