NCT00733928

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for phase_4 knee-osteoarthritis

Timeline
Completed

Started Oct 1999

Longer than P75 for phase_4 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2008

Completed
6.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

5.6 years

First QC Date

August 11, 2008

Last Update Submit

March 28, 2025

Conditions

Knee Osteoarthritis

Keywords

Arthroplasty,Replacement,Knee,P.F.C.Sigmaall-polyethylene

Outcome Measures

Primary Outcomes (1)

  • 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

    2 years

Secondary Outcomes (1)

  • 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

    6 months, 1 year and 2 years

Study Arms (2)

1 - All Polyethylene Tibia

OTHER

Total knee replacement with an all polyethylene tibial tray

Device: PFC Sigma knee with all-poly tibial component

2 - Poly & Metal Tibia

ACTIVE COMPARATOR

Total knee replacement with a metal-backed tibial component

Device: PFC Sigma knee with metal backed tibia

Interventions

PFC Sigma knee with all-poly tibial componentDEVICE

Orthopaedic implant for total knee replacement with an all-polyethylene tibial component

1 - All Polyethylene Tibia
PFC Sigma knee with metal backed tibiaDEVICE

Orthopaedic implant for total knee replacement with a metal-backed tibial component

2 - Poly & Metal Tibia

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthopaedics, Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Related Publications (1)

  • Muller SD, Deehan DJ, Holland JP, Outterside SE, Kirk LM, Gregg PJ, McCaskie AW. Should we reconsider all-polyethylene tibial implants in total knee replacement? J Bone Joint Surg Br. 2006 Dec;88(12):1596-602. doi: 10.1302/0301-620X.88B12.17695.

    PMID: 17159170RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2008

First Posted

August 13, 2008

Study Start

October 1, 1999

Primary Completion

May 1, 2005

Study Completion

March 1, 2015

Last Updated

March 30, 2025

Record last verified: 2025-03

Locations

GB(1)