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

Osteoarthritis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00761410
• Other study ID #: CT0153
• Status: Terminated
• Phase: Phase 4
• First received: September 26, 2008
• Last updated: June 17, 2016
• Start date: October 2004
• Est. completion date: May 2015

Study information

• Verified date: June 2016
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 170
• Est. completion date: May 2015
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Countries where clinical trial is conducted

India,  Japan,  Korea, Republic of,  New Zealand,  Singapore,  Thailand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	Radiographic assessments at 1, 2, 3, 5, 10, 15 and 20 years		1, 2, 3 and 5 years	No
Secondary	Oxford Knee Score at 1, 2, 3, 5, 10, 15 and 20 years		1, 2, 3 and 5 years	No
Secondary	Patellar Score at 1, 2, 3, 5, 10, 15 and 20 years		1, 2, 3 and 5 years	No
Secondary	SF-12 1, 2, 3, 5, 10, 15 and 20 years		1, 2, 3 and 5 years	No