A Study to Determine the Performance of the Press Fit Condylar (P.F.C.) Sigma RP-F Knee System

A Prospective, Non-Comparative Multi Centre Study to Evaluate the Clinical Performance of the DePuy Press Fit Condylar (P.F.C.) Sigma Rotating Platform High Flexion Knee.

The purpose of this study is to evaluate if the P.F.C. Sigma RPF knee accommodates functional stability with a post-operative passive range of motion of greater than 125° of flexion and to demonstrate that the range of motion does not compromise the longevity of the implant.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: P.F.C. Sigma RP-F Total Knee Replacement

Detailed Description

Primary endpoint is to demonstrate that 90% of patients have a functionally stable knee that can achieve post operative range of motion of 125 degrees or greater.

The secondary endpoint is to investigate the survivorship of the P.F.C. Sigma RP-F knee at 1, 2, 3, 5, 10, 15 and 20 years

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400 054
      • The Nook, 51/B SV Road
• Japan
  • Kobe
    • Chuoku, Kobe, Japan
      • Kobe University Graduate School Of Medicine, 7-5-1 Kusundki- cho
• Korea, Republic of
  • Seoul
    • Dongdaemun Gu, Seoul, Korea, Republic of
      • Kyunghee University Hospital, 1 HoegiDong
• New Zealand
  • Wellington
    • Newtown, Wellington, New Zealand
      • Wellington School Of Medicine Surgical Research Trust, Main Street
• Singapore
  • Tan Tock Seng, Singapore, 308433
    • Tan Tock Seng Hospital, No 11 Jalan
• Thailand
  • Bangkok, Thailand, 10700
    • Sirriraj Hospital, Mahidol University
• United Kingdom
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham City Hospital, Hucknell Road
  • York, United Kingdom
    • Clifton Park NHS Treatment Centre, Blue Beck Drive, Shipton Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 investigation and from whom consent has been obtained.
• Subjects who are able to achieve a pre-operative passive range of motion of equal to or greater than 110º.
• 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 present with idiopathic 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 the P.F.C.® Sigma RPF knee, according to the indications specified in the package insert leaflet.

Exclusion Criteria:

• Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.
• 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 have participated in a clinical study with an investigational product in the last month (30 days).
• Subjects who are currently involved in any personal injury litigation claims.
• Subjects with a known history of poor compliance to medical treatment.
• Subjects who have a pre-operative limb deformity of equal to or greater than 10° varus or 15° valgus as defined using the anatomical axis.
• Subjects who have morbid obesity i.e. BMI ≥40.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: P.F.C. Sigma RP-F Total Knee Replacement; An orthopaedic implant for total knee replacement with a mobile-bearing and a high flexion design	Device: P.F.C. Sigma RP-F Total Knee Replacement; An orthopaedic implant for total knee replacement with a mobile-bearing and a high flexion design

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with a functionally stable knee that can achieve post-operative range of motion of 125° or greater.	Proportion of cases that have a functionally stable knee (Q10 of Oxford Knee Score is 'rarely/never' or 'sometimes, or just at first'), AND can achieve 1-year post-op passive range of motion of 125 degrees or greater.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Survivorship of the P.F.C.® Sigma RPF knee at 1, 2, 3, 5, 10, 15 and 20 years.	1, 2, 3 and 5 years
American Knee Society Change from Baseline Knee and Function Scores at 1, 2, 3, 5, 10, 15 and 20 years	1, 2, 3 and 5 years
Radiographic assessments at 1, 2, 3, 5, 10, 15 and 20 years	1, 2, 3 and 5 years
Oxford Knee Score at 1, 2, 3, 5, 10, 15 and 20 years	1, 2, 3 and 5 years
Patellar Score at 1, 2, 3, 5, 10, 15 and 20 years	1, 2, 3 and 5 years
SF-12 1, 2, 3, 5, 10, 15 and 20 years	1, 2, 3 and 5 years

Collaborators and Investigators

• Sponsor: DePuy International

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (ACTUAL): February 1, 2010
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: September 26, 2008
• First Submitted That Met QC Criteria: September 26, 2008
• First Posted (ESTIMATE): September 29, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 20, 2016
• Last Update Submitted That Met QC Criteria: June 17, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Arthroplasty; Replacement; Knee; High Flexion; PFC Sigma RP-F
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: CT0153