Comparison of Mobile-Bearing and Fixed-Bearing All-Polyethylene Tibia Total Knee Designs

Osteoarthritis, Knee Clinical Trial

Official title:

A Randomized Prospective Comparison of Mobile-Bearing and Fixed-Bearing (All-Polyethylene Tibia) Cruciate-Substituting Total Knee Arthroplasty (TKA) Designs

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00894361
• Other study ID #: MVA-3028
• Status: Terminated
• Phase: Phase 4
• Start date: October 2001
• Est. completion date: January 2007

Study information

• Verified date: September 2020
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be designed to compare prospectively, in a randomized fashion, the clinical, functional, and radiographic results of a nonmodular (all-polyethylene tibi/AP) fixed-bearing posterior cruciate substituting design with a modular posterior cruciate substituting rotating platform (RP) design for total knee arthroplasty. Comparing these two designs will afford the investigators information in the following areas:

1. Does a RP design offer improvement in range of motion over a AP design?

2. Does a RP design have improved wear characteristics over a nonmodular AP design?

3. Is there a clear clinical advantage to the RP design that justifies its increased cost?

Answering these questions will allow surgeons to use RP designs appropriately in different demand populations.

This study was designed to address the questions of whether an RP design offers improvement in ROM, Knee Society scores, Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) scores, selected Medical Outcomes Short-Form Health Survey Short Form-36 (SF-36) scores or radiographic measures, over an APT design. The investigators' primary hypothesis was that there would be no difference in these outcome measures at a minimum two year followup. A secondary hypothesis based on the anticipated long-term followup of this group was that there would be no difference in implant survival.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

Inclusion Criteria:

• generally accepted clinical and radiographic criteria for primary total knee arthroplasty

Exclusion Criteria:

• substantial angular deformity or bony deformity requiring structural grafting or modular augmentation were excluded at the discretion of the principle investigator

• patients whose mental function precluded them from responding to our standard questionnaires

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Procedure:
• TKA surgery with the rotating platform mobile-bearing knee design
Depuy Sigma RP rotating platform design
• TKA surgery with the all-polyethylene tibia knee design
Depuy Sigma fixed-bearing design with all-polyethylene tibia

Locations

Country	Name	City	State
United States	Minneapolis VAMC	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minneapolis Veterans Affairs Medical Center	Depuy, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gioe TJ, Glynn J, Sembrano J, Suthers K, Santos ER, Singh J. Mobile and fixed-bearing (all-polyethylene tibial component) total knee arthroplasty designs. A prospective randomized trial. J Bone Joint Surg Am. 2009 Sep;91(9):2104-12. doi: 10.2106/JBJS.H.01 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Postoperative Range of Motion (ROM) at 2 Years	range of motion of the knee postoperatively at 2 years	2 years
Secondary	Survival of the Implants to Subject Death or Implant Removal		10 or more years