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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00957021
First received: August 10, 2009
Last updated: July 11, 2014
Last verified: July 2014
  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.


Condition Intervention
Arthroplasty, Replacement, Knee
Device: Triathlon® PS Total Knee System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group 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

Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • Range of Motion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The primary outcome of this study is to compare active range of motion values for the Triathlon PS Total Knee System.


Secondary Outcome Measures:
  • Patient Outcome Knee Society Score [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The Knee Society Scores (KSS) at 1, 2, and 5-year visits will be compared between groups, when data is available. Additionally, comparison of scores at each post-surgery visit with baseline will be tested to see if any improvement is seen at each time point.

  • Patient Outcome SF-36 [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The SF-36 score at 1, 2, 3, 4 and 5-year visits will be compared at each post-surgery visit with baseline to see if any improvement is seen for each time point.

  • Patient Outcome WOMAC [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The Western Ontario and McMaster Osteoarthritis Index (WOMAC) scores at 1, 2, 3, 4 and 5-year visits will be compared between groups, when data is available. Additionally, comparison of scores at each post-surgery visit with baseline will be tested to see if any improvement is seen for each time point.

  • Patient Outcome Lower-Extremity Activity Scale [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The Lower-Extremity Activity Scale score at 1, 2, 3, 4 and 5-year intervals will be compared at each post-surgery visit with baseline to see if any improvement is seen for each time point.

  • Radiographic Outcome [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Radiographic success/failure at 1, 2, and 5-year visits will be assessed. Radiographic failure is defined as a score of 10 or greater according to the Knee Society Roentgenographic Scoring System, regardless of symptoms. A migrating or shifting prosthesis with or without the disappearance of radiolucent lines is also a failure regardless of score.


Enrollment: 409
Study Start Date: December 2005
Study Completion Date: January 2014
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Triathlon® PS Total Knee System
Triathlon® PS Total Knee System
Device: Triathlon® PS Total Knee System
Triathlon® PS Total Knee system

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 degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis (excluded from this study according to protocol).

The components are designed to improve range of motion (ROM) and stability. This study serves to demonstrate that subjects have reduced pain, increased ROM and improved stability following implantation with the Triathlon® PS Total Knee System.

  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 the 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 postoperative 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: September 5, 2013
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014