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

Knee Osteoarthritis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733928
• Other study ID #: CT 99/26
• Status: Completed
• Phase: Phase 4
• First received: August 11, 2008
• Last updated: May 27, 2016
• Start date: October 1999
• Est. completion date: March 2015

Study information

• Verified date: May 2016
• Source: DePuy International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 2015
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• PFC Sigma knee with all-poly tibial component
Orthopaedic implant for total knee replacement with an all-polyethylene tibial component
• PFC Sigma knee with metal backed tibia
Orthopaedic implant for total knee replacement with a metal-backed tibial component

Locations

Country	Name	City	State
United Kingdom	Department of Orthopaedics, Freeman Hospital	Newcastle upon Tyne

Sponsors (1)

Lead Sponsor	Collaborator
DePuy International

Country where clinical trial is conducted

United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No