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

Primary Purpose

Osteoarthritis

Status

Terminated

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

P.F.C. Sigma RP-F Total Knee Replacement

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Arthroplasty, Knee, Replacement, High Flexion, PFC Sigma RP-F

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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 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.

Sites / Locations

The Nook, 51/B SV Road
Kobe University Graduate School Of Medicine, 7-5-1 Kusundki- cho
Kyunghee University Hospital, 1 HoegiDong
Wellington School Of Medicine Surgical Research Trust, Main Street
Tan Tock Seng Hospital, No 11 Jalan
Sirriraj Hospital, Mahidol University
Nottingham City Hospital, Hucknell Road
Clifton Park NHS Treatment Centre, Blue Beck Drive, Shipton Road

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

P.F.C. Sigma RP-F Total Knee Replacement

Arm Description

An orthopaedic implant for total knee replacement with a mobile-bearing and a high flexion design

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Survivorship of the P.F.C.® Sigma RPF knee at 1, 2, 3, 5, 10, 15 and 20 years.

American Knee Society Change from Baseline Knee and Function Scores at 1, 2, 3, 5, 10, 15 and 20 years

Radiographic assessments at 1, 2, 3, 5, 10, 15 and 20 years

Oxford Knee Score at 1, 2, 3, 5, 10, 15 and 20 years

Patellar Score at 1, 2, 3, 5, 10, 15 and 20 years

SF-12 1, 2, 3, 5, 10, 15 and 20 years

Full Information

NCT ID

NCT00761410

First Posted

September 26, 2008

Last Updated

June 17, 2016

Sponsor

DePuy International

1. Study Identification

Unique Protocol Identification Number

NCT00761410

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Terminated

Why Stopped

Study was terminated early due to prolonged recruitment period.

Study Start Date

October 2004 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

DePuy International

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis

Keywords

Arthroplasty, Knee, Replacement, High Flexion, PFC Sigma RP-F

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

170 (Actual)

8. Arms, Groups, and Interventions

Arm Title

P.F.C. Sigma RP-F Total Knee Replacement

Arm Type

Other

Arm Description

An orthopaedic implant for total knee replacement with a mobile-bearing and a high flexion design

Intervention Type

Device

Intervention Name(s)

P.F.C. Sigma RP-F Total Knee Replacement

Intervention Description

An orthopaedic implant for total knee replacement with a mobile-bearing and a high flexion design

Primary Outcome Measure Information:

Title

Number of patients with a functionally stable knee that can achieve post-operative range of motion of 125° or greater.

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Survivorship of the P.F.C.® Sigma RPF knee at 1, 2, 3, 5, 10, 15 and 20 years.

Time Frame

1, 2, 3 and 5 years

Title

American Knee Society Change from Baseline Knee and Function Scores at 1, 2, 3, 5, 10, 15 and 20 years

Time Frame

1, 2, 3 and 5 years

Title

Radiographic assessments at 1, 2, 3, 5, 10, 15 and 20 years

Time Frame

1, 2, 3 and 5 years

Title

Oxford Knee Score at 1, 2, 3, 5, 10, 15 and 20 years

Time Frame

1, 2, 3 and 5 years

Title

Patellar Score at 1, 2, 3, 5, 10, 15 and 20 years

Time Frame

1, 2, 3 and 5 years

Title

SF-12 1, 2, 3, 5, 10, 15 and 20 years

Time Frame

1, 2, 3 and 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 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.

Facility Information:

Facility Name

The Nook, 51/B SV Road

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400 054

Country

India

Facility Name

Kobe University Graduate School Of Medicine, 7-5-1 Kusundki- cho

City

Chuoku

State/Province

Kobe

Country

Japan

Facility Name

Kyunghee University Hospital, 1 HoegiDong

City

Dongdaemun Gu

State/Province

Seoul

Country

Korea, Republic of

Facility Name

Wellington School Of Medicine Surgical Research Trust, Main Street

City

Newtown

State/Province

Wellington

Country

New Zealand

Facility Name

Tan Tock Seng Hospital, No 11 Jalan

City

Tan Tock Seng

ZIP/Postal Code

308433

Country

Singapore

Facility Name

Sirriraj Hospital, Mahidol University

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

Nottingham City Hospital, Hucknell Road

City

Nottingham

ZIP/Postal Code

NG5 1PB

Country

United Kingdom

Facility Name

Clifton Park NHS Treatment Centre, Blue Beck Drive, Shipton Road

City

York

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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