The Press Fit Condylar (P.F.C.) Sigma Metal-backed Versus All-poly

May 27, 2016 updated by: DePuy International

Randomised Prospective Comparison of P.F.C All-polyethylene Versus Metal-backed Tibial Component. A Clinical, Radiological and Roentgen Stereophotogrammetric Analysis (RSA) Study.

The primary objective of this investigation was to evaluate & compare the performance of the P.F.C. Sigma Knee Cruciate-retaining all-polyethylene and metal-backed tibia components using RSA.

The secondary objectives of this investigation are to evaluate the clinical and patient outcomes and survivorship associated with the P.F.C. Sigma Knee Cruciate-retaining all-polyethylene and metal-backed tibia components.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Using RSA, is it possible to evaluate the performance of both the all polyethylene and metal backed tibia components to determine whether there are differences in migration, if present, across the tibial components.

The original protocol intended to perform clinical assessment using the Nottingham Knee Score and the Knee Society Clinical rating system pre-and post-operatively, at six months, 1 year, and annually thereafter. Per Protocol Amendment 01 (effective June 18, 1999) clinical data would also be collected via the SF-12 questionnaire. Radiological evaluation would also use the Knee Society scoring system at the same time points. However, data collected included only the SF-12 and Oxford Knee Scores, comparing change from baseline at 6, 12, and 24 months after surgery.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Department of Orthopaedics, Freeman Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects requiring a primary knee replacement.
  • Subjects aged 65 years or more.
  • Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
  • Subjects with a primary diagnosis of osteoarthritis or rheumatoid arthritis.

Exclusion Criteria:

  • Subjects who have had a previous surgery of the operative knee except menisectomy and arthroscopy.
  • Subjects who have had a renal transplant.
  • Subjects with a metabolic bone disorder.
  • Subjects who, in the opinion of the Clinical Investigator, have an existing condition, e.g. Paget's disease etc. that would compromise their participation and follow-up in this clinical investigation.
  • Subjects whose contralateral knee is already included in this study.
  • Subjects who have a history of active joint sepsis.
  • Subjects who have a recent history of high dose systemic corticosteroids.
  • Subjects with psycho-social disorders or physical disabilities that would limit rehabilitation.
  • Subjects requiring a bone graft.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 1 - All Polyethylene Tibia
Total knee replacement with an all polyethylene tibial tray
Device: PFC Sigma knee with all-poly tibial component
Orthopaedic implant for total knee replacement with an all-polyethylene tibial component
ACTIVE_COMPARATOR: 2 - Poly & Metal Tibia
Total knee replacement with a metal-backed tibial component
Device: PFC Sigma knee with metal backed tibia
Orthopaedic implant for total knee replacement with a metal-backed tibial component

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Using RSA it is possible to evaluate the performance of both the all-polyethylene and metal-backed tibia components to determine whether there are differences in migration between the two components
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparative evaluation of any post-operative variation between subjects receiving all-polyethylene and metal-backed tibia components in change from baseline at each post operative time points in terms of SF 12 and OKS
Time Frame: 6 months, 1 year and 2 years
6 months, 1 year and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DePuy International

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1999

Primary Completion (ACTUAL)

May 1, 2005

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

August 11, 2008

First Submitted That Met QC Criteria

August 12, 2008

First Posted (ESTIMATE)

August 13, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 1, 2016

Last Update Submitted That Met QC Criteria

May 27, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT 99/26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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