Status:

COMPLETED

Comparison of High Flex and Standard Rotating Platform Total Knee Arthroplasty (TKA)

Lead Sponsor:

Anderson Orthopaedic Research Institute

Collaborating Sponsors:

DePuy Orthopaedics

Conditions:

Knee Osteoarthritis

Eligibility:

All Genders

40-75 years

Phase:

NA

Brief Summary

The goal of this study is to determine if the rotating platform high flex design provides improved flexion compared to the standard rotating platform TKA.

Eligibility Criteria

Inclusion

  • Age 40 to 75 years old
  • Primary diagnosis of osteoarthritis of the knee
  • Patients who, in the investigator's opinion, are appropriate candidates for a cemented, rotating platform TKA.
  • Patients who, in the investigator's opinion, are capable of participation in a clinical trial and reliable enough to return for follow-up appointments.

Exclusion

  • Pregnant or lactating female subjects
  • Patients with post-traumatic or inflammatory arthritis
  • Patients with a fixed flexion contracture of greater than 20 degrees
  • Patients with advanced hip, spine, or ankle disease
  • Patients with a BMI greater than 40, where knee flexion may be limited by soft tissues

Key Trial Info

Start Date :

August 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2012

Estimated Enrollment :

142 Patients enrolled

Trial Details

Trial ID

NCT01176292

Start Date

August 1 2007

End Date

May 1 2012

Last Update

November 23 2020

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