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TerminatedNCT00761410Updated Jun 20, 2016

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

A Phase 4 interventional study of P.F.C. Sigma RP-F Total Knee Replacement in Osteoarthritis, sponsored by DePuy International. Terminated at 8 sites in 7 countries. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-06-20.

Sponsored by DePuy International · Phase 4, Interventional, and Treatment

Why this study was terminated
Study was terminated early due to prolonged recruitment period.
Phase
Phase 4
Study type
Interventional
Enrollment
170
Allocation
Not applicable
Ages
45 Years to 75 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Osteoarthritis

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Keywords

  • Arthroplasty
  • Knee
  • Replacement
  • High Flexion
  • PFC Sigma RP-F
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 170 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

DePuy International is the lead sponsor of 41 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
170 participants (actual)

Study arms

  • 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

Interventions

  • DeviceP.F.C. Sigma RP-F Total Knee Replacement

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

Secondary outcomes

  1. 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

  2. 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

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

    Time frame: 1, 2, 3 and 5 years

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

    Time frame: 1, 2, 3 and 5 years

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

    Time frame: 1, 2, 3 and 5 years

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

    Time frame: 1, 2, 3 and 5 years

07

Study locations

8 sites
  • The Nook, 51/B SV Road
    Mumbai, Maharashtra 400 054, India
  • Kobe University Graduate School Of Medicine, 7-5-1 Kusundki- cho
    Chuoku, Kobe, Japan
  • Kyunghee University Hospital, 1 HoegiDong
    Dongdaemun Gu, Seoul, Korea, Republic of
  • Wellington School Of Medicine Surgical Research Trust, Main Street
    Newtown, Wellington, New Zealand
  • Tan Tock Seng Hospital, No 11 Jalan
    Tan Tock Seng, 308433, Singapore
  • Sirriraj Hospital, Mahidol University
    Bangkok, 10700, Thailand
  • Nottingham City Hospital, Hucknell Road
    Nottingham, NG5 1PB, United Kingdom
  • Clifton Park NHS Treatment Centre, Blue Beck Drive, Shipton Road
    York, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00761410
Lead sponsor
DePuy International
Responsible party
Sponsor
First posted
Sep 29, 2008
Start date
Oct 2004
Primary completion
Feb 2010
Completion
May 2015
Last update
Jun 20, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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