A Study to Compare the Press Fit Condylar (P.F.C.) Sigma Rotating-platform High-flexion (RP-F) Versus the Press Fit Condylar (P.F.C.) Sigma Rotating-platform (RP) Knee Implants

DePuy Synthes

Status and phase

Terminated

Phase 4

Conditions

Knee Osteoarthritis

Treatments

Device: PFC Sigma RP

Device: PFC Sigma RP-F

Study type

Interventional

Funder types

Industry

Identifiers

NCT00733369

CT 06/03

Details and patient eligibility

About

The main objective of this study is to determine if the P.F.C. Sigma RP-F Knee delivers a greater post-operative range of motion (ROM) compared with the P.F.C. Sigma RP Knee in primary TKA.

The secondary objectives of this investigation are to evaluate the clinical and patient outcomes and survivorship associated with the DePuy P.F.C. Sigma RP-F and RP Posterior Stabilised (PS) Knee over 5 years.

Full description

Primary Outcome: Change from pre-operative range of motion at 1 year between patients receiving P.F.C. Sigma RP vs P.F.C. Sigma RP-F

Secondary endpoints: Comparative evaluation of any post-operative variation between subjects receiving primary TKA with either of the above devices in terms of Knee and Osteoarthritis Scores (KOOS), American Knee Society Score (AKS), EQ-5D Score and Oxford Knee Score (OKS)

Enrollment

106 patients

Sex

All

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female subjects, aged between 45 and 75 years inclusive.
Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical 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 present with osteoarthritis that in the opinion of the clinical investigator requires a primary total knee arthroplasty.
Subjects who in the opinion of the Clinical Investigator are considered to be suitable for treatment with either the P.F.C Sigma RP-F or the P.F.C Sigma RP knee, according to the indications specified in the package insert leaflet.
Subjects who have authorised the transfer of his/her pseudonymised information to DePuy.

Exclusion criteria

Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation.
Female subjects who are pregnant or lactating.
Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.
Subjects who have participated in a clinical investigation with an investigational product in the last month( 30 days).
Subjects who are currently involved in any injury litigation claims.
Subjects with a known history of poor compliance to medical treatment.
Subjects who have previously had an osteotomy or significant surgery in the affected knee.