Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been terminated.
(Study was terminated early due to prolonged recruitment period.)
Sponsor:
Information provided by (Responsible Party):
DePuy International
ClinicalTrials.gov Identifier:
NCT00761410
First received: September 26, 2008
Last updated: June 17, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention Phase
Osteoarthritis
Device: P.F.C. Sigma RP-F Total Knee Replacement
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by DePuy International:

Primary Outcome Measures:
  • Number of patients with a functionally stable knee that can achieve post-operative range of motion of 125° or greater. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1, 2, 3 and 5 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Radiographic assessments at 1, 2, 3, 5, 10, 15 and 20 years [ Time Frame: 1, 2, 3 and 5 years ] [ Designated as safety issue: No ]
  • Oxford Knee Score at 1, 2, 3, 5, 10, 15 and 20 years [ Time Frame: 1, 2, 3 and 5 years ] [ Designated as safety issue: No ]
  • Patellar Score at 1, 2, 3, 5, 10, 15 and 20 years [ Time Frame: 1, 2, 3 and 5 years ] [ Designated as safety issue: No ]
  • SF-12 1, 2, 3, 5, 10, 15 and 20 years [ Time Frame: 1, 2, 3 and 5 years ] [ Designated as safety issue: No ]

Enrollment: 170
Study Start Date: October 2004
Study Completion Date: May 2015
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761410

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

Responsible Party: DePuy International
ClinicalTrials.gov Identifier: NCT00761410     History of Changes
Other Study ID Numbers: CT0153 
Study First Received: September 26, 2008
Last Updated: June 17, 2016
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by DePuy International:
Arthroplasty
Knee
Replacement
High Flexion
PFC Sigma RP-F

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 23, 2016