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

Primary Purpose

Knee Osteoarthritis

Status

Completed

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

PFC Sigma knee with all-poly tibial component

PFC Sigma knee with metal backed tibia

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Arthroplasty,, Replacement,, Knee,, P.F.C., Sigma, all-polyethylene

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Orthopaedics, Freeman Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

1 - All Polyethylene Tibia

2 - Poly & Metal Tibia

Arm Description

Total knee replacement with an all polyethylene tibial tray

Total knee replacement with a metal-backed tibial component

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00733928

First Posted

August 11, 2008

Last Updated

May 27, 2016

Sponsor

DePuy International

1. Study Identification

Unique Protocol Identification Number

NCT00733928

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

October 1999 (undefined)

Primary Completion Date

May 2005 (Actual)

Study Completion Date

March 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 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.

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.

6. Conditions and Keywords

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

Knee Osteoarthritis

Keywords

Arthroplasty,, Replacement,, Knee,, P.F.C., Sigma, all-polyethylene

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1 - All Polyethylene Tibia

Arm Type

Other

Arm Description

Total knee replacement with an all polyethylene tibial tray

Arm Title

2 - Poly & Metal Tibia

Arm Type

Active Comparator

Arm Description

Total knee replacement with a metal-backed tibial component

Intervention Type

Device

Intervention Name(s)

PFC Sigma knee with all-poly tibial component

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

PFC Sigma knee with metal backed tibia

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Time Frame

6 months, 1 year and 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Department of Orthopaedics, Freeman Hospital

City

Newcastle upon Tyne

ZIP/Postal Code

NE7 7DN

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

17159170

Citation

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.

Results Reference

result

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

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