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

NCT00894361 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2020-09-07

Study results available
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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.

Conditions

  • Osteoarthritis, Knee

Interventions

PROCEDURE

TKA surgery with the rotating platform mobile-bearing knee design

Depuy Sigma RP rotating platform design

PROCEDURE

TKA surgery with the all-polyethylene tibia knee design

Depuy Sigma fixed-bearing design with all-polyethylene tibia

Sponsors & Collaborators

  • Depuy, Inc.

    collaborator INDUSTRY

  • Minneapolis Veterans Affairs Medical Center

    lead FED

Principal Investigators

  • Terence J Gioe, M.D. · Minneapolis VAMC, Dept. of Orthopaedic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-10-31
Primary Completion
2007-01-31
Completion
2007-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00894361 on ClinicalTrials.gov