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

NCT ID: NCT00733369

Last Updated: 2016-09-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2014-08-31

Brief Summary

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.

Detailed 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)

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

PFC Sigma RP-F

125 patients to be allocated to this arm according to blinding envelopes

Group Type: OTHER

PFC Sigma RP-F

Intervention Type: DEVICE

An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing

PFC Sigma RP

125 patients to be allocated to this arm according to blinding envelopes

Group Type: ACTIVE_COMPARATOR

PFC Sigma RP

Intervention Type: DEVICE

An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing

Interventions

PFC Sigma RP-F

An orthopaedic implant for total knee replacement with a high flexion rotating platform bearing

Intervention Type: DEVICE

PFC Sigma RP

An orthopaedic implant for total knee replacement with a standard flexion rotating platform bearing

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DePuy International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Clinic i Provincial de Barcelona

Barcelona, , Spain

Arrowe Park Hospital

Metropolitan Borough of Wirral, Mersyside, United Kingdom

Countries

Spain; United Kingdom

Other Identifiers

CT 06/03

Identifier Type: -

Identifier Source: org_study_id