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Status:

COMPLETED

Triathlon® Posteriorly Stabilized (PS) Total Knee System - Outcomes Study

Lead Sponsor:

Stryker Orthopaedics

Conditions:

Arthroplasty, Replacement, Knee

Eligibility:

All Genders

21-80 years

Phase:

NA

Brief Summary

The purpose of this study is to evaluate the clinical outcomes (range of motion, pain, function, radiographic stability, and health related quality of life) of patients receiving the Triathlon® Poster...

Detailed Description

The Triathlon® Posteriorly Stabilized (PS) Total Knee System components are for use in cemented total knee arthroplasty for painful, disabling joint disease of the knee resulting from non-inflammatory...

Eligibility Criteria

Inclusion

  • The subject is a male or non-pregnant female 21-80 years of age at the time of enrollment.
  • The subject requires a primary cemented total knee replacement.
  • The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
  • The subject has intact collateral ligaments.
  • The subject has signed the IRB approved, study specific Informed Patient Consent Form.
  • The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion

  • The subject has inflammatory arthritis.
  • The subject is morbidly obese, BMI \> 40.
  • The subject has a history of total or unicompartmental reconstruction of the affected joint.
  • The subject has had a high tibial osteotomy or femoral osteotomy.
  • The subject has a neuromuscular or neurosensory deficiency that would limit the ability to assess the performance of the device.
  • The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
  • The subject is immunologically suppressed, or receiving chronic steroids (\>30 days duration).
  • The subject's bone stock is compromised by disease or infection and cannot provide adequate support and/or fixation to the prosthesis.
  • The subject has had a knee fusion at the affected joint.
  • The subject has an active or suspected latent infection in or about the knee joint.
  • The subject is a prisoner.

Key Trial Info

Start Date :

December 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2014

Estimated Enrollment :

409 Patients enrolled

Trial Details

Trial ID

NCT00957021

Start Date

December 1 2005

End Date

January 1 2014

Last Update

January 25 2017

Active Locations (11)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (11 locations)

1

Hughston Clinic PA

Columbus, Georgia, United States, 31908

2

Ireland Hip and Knee Surgery

Indianapolis, Indiana, United States, 46260

3

New England Baptist Hospital

Boston, Massachusetts, United States, 02120

4

Pro-Sports Orthopaedics, Inc. / New England Baptist Hospital

Boston, Massachusetts, United States, 02445