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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00957021
First received: August 10, 2009
Last updated: August 8, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Posterior Stabilized (PS) Total Knee System. These outcomes will be evaluated using pre-operative scores and comparing them to post-operative scores in addition to being compared with cases who received the Scorpio PS implant in the Scorpio IDE study.


Condition Intervention
Arthroplasty, Replacement, Knee
 Device: Triathlon Posterior Stabilized (PS) Total Knee System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon Posteriorly Stabilized (PS) Total Knee System

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement
U.S. FDA Resources

Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • To compare the active range of motion values for subjects receiving the Triathlon PS Total Knee System with data from subjects who received the Scorpio PS implant in the Scorpio IDE study. [ Time Frame: at 2 years follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare pain, function, radiographic outcomes, and health related quality of life with subjects' pre-operative status as well as with the control group (Scorpio PS), where available. [ Time Frame: at 2 years follow-up ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: December 2005
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ARM 1: N2VAC Polyethylene
The Arm 1: N2VAC cases received the Triathlon PS N2VAC polyethylene tibial insert and the Triathlon PS N2VAC polyethylene patellar.
 Device: Triathlon Posterior Stabilized (PS) Total Knee System
To evaluate the Triathlon (PS) Total Knee System with cases using the Triathlon PS N2VAC polyethylene tibial insert and patellar component against Scorpio PS Knee System.
Arm 2: X3 Polyethylene
The Arm 2: X3 cases received the Triathlon PS X3 polyethylene tibial insert and the Triathlon PS X3 polyethylene patellar component.
 Device: Triathlon Posterior Stabilized (PS) Total Knee System
To evaluate the Triathlon (PS) Total Knee System with cases using the Triathlon PS X3 polyethylene tibial insert and patellar component against Scorpio PS Knee System.

Detailed Description:

Primary total knee arthroplasty has consistently shown to be successful in relieving pain and improving function for those experiencing difficulties of degenerative joint disease. In recent years, patient quality of life and return to function have become of greater importance in assessing the success of joint replacement. While essential functions such as walking and stair climbing are of obvious importance in outcomes, patients also expect to return to other daily activities such as shopping, household duties and gardening, to name a few. While knee replacement to date has demonstrated improvement in standard clinical results, studies have shown an increase in the prevalence of knee symptoms when patients were asked about activities that placed greater load on the extremity (i.e. carrying shopping bags), or demanded increased knee flexion (i.e. gardening, kneeling, squatting). Some literature has indicated that the component design (cam - post interactions in posterior stabilized knees and impingement of the posterior aspect of the tibial insert against the posterior aspect of the femur in cruciate retaining knees) has contributed to the patient's inability or discomfort in performing more demanding activities of daily living.

The Triathlon Knee System has been designed with these activities in mind and this study will evaluate the clinical outcomes(range of motion, pain, function, radiographic stability, and health related quality of life) of patients receiving the device.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. The subject has inflammatory arthritis.
  2. The subject is morbidly obese, BMI > 40.
  3. The subject has a history of total or unicompartmental reconstruction of the affected joint.
  4. The subject has had a high tibial osteotomy or femoral osteotomy.
  5. The subject has a neuromuscular or neurosensory deficiency that would limit the ability to assess the performance of the device.
  6. The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
  7. The subject is immunologically suppressed, or receiving chronic steroids (>30 days duration).
  8. The subject's bone stock is compromised by disease or infection and cannot provide adequate support and/or fixation to the prosthesis.
  9. The subject has had a knee fusion at the affected joint.
  10. The subject has an active or suspected latent infection in or about the knee joint.
  11. The subject is a prisoner.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00957021

Locations
United States, Georgia
Hughston Clinic PA
Columbus, Georgia, United States, 31908
United States, Indiana
Ireland Hip and Knee Surgery
Indianapolis, Indiana, United States, 46260
United States, Massachusetts
New England Baptist Hospital
Boston, Massachusetts, United States, 02120
Pro-Sports Orthopaedics, Inc. / New England Baptist Hospital
Boston, Massachusetts, United States, 02445
United States, Minnesota
St. Cloud Orthopaedic Associates
Sartell, Minnesota, United States, 56377
United States, New Hampshire
New Hampshire Orthopaedic Surgery, PA
Manchester, New Hampshire, United States, 03103
United States, New York
Specialty Orthopaedics
Harrison, New York, United States, 10528
United States, Ohio
Wellington Orthopaedics & Sports Medicine
Cincinnati, Ohio, United States, 45255
Tri County Orthopedic Surgeons, Inc.
Massillon, Ohio, United States, 44646
United States, Texas
Kelsey-Seybold Clinic
Houston, Texas, United States, 77025
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
Stryker Orthopaedics
Investigators
Principal Investigator: Eric R Benson, MD New Hampshire Orthopaedic Surgery, PA
Principal Investigator: Daniel Moretta, DO Tri County Orthopedics Surgeons, Inc.
Principal Investigator: James Bono, MD New England Baptist Hospital
Principal Investigator: David W Edelstein, MD Kelsey-Seybold Clinic
Principal Investigator: Philip Ireland, MD Ireland Hip and Knee Surgery
Principal Investigator: Joseph P Nessler, MD St. Cloud Orthopaedic Associates
Principal Investigator: Quanjun Cui, MD University of Virginia
Principal Investigator: Arnold Scheller, MD Pro-Sports Orthopaedics, Inc./ New England Baptist Hospital
Principal Investigator: Joel Sorger, MD Wellington Orthopaedics and Sports Medicine
Principal Investigator: Suresh Nayak, MD Wellington Orthopaedics and Sports Medicine
Principal Investigator: John I Waldrop, MD Hughston Clinic, PA
Principal Investigator: James McGrory, MD Hughston Clinic, PA
Principal Investigator: Steven B Zelicof, MD, PhD Specialty Orthopaedics
  More Information

No publications provided

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00957021     History of Changes
Other Study ID Numbers: 55
Study First Received: August 10, 2009
Last Updated: August 8, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on June 18, 2013