Triathlon® Partial Knee Replacement (PKR) Outcomes Study

This study is currently recruiting participants.
Verified December 2013 by Stryker Orthopaedics
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics
ClinicalTrials.gov Identifier:
NCT00966979
First received: August 25, 2009
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

The purpose of the study is to evaluate the Triathlon® PKR Knee System to determine whether or not the success rate of this device is no worse than the reported success rate of similar devices.


Condition Intervention
Arthroplasty, Replacement, Knee
Device: Triathlon PKR

Study Type: Interventional
Study Design: 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® Partial Knee Resurfacing (PKR) Unicondylar Knee System

Resource links provided by NLM:


Further study details as provided by Stryker Orthopaedics:

Primary Outcome Measures:
  • To compare 10 year implant success rate for subjects receiving the Triathlon® PKR to those rates stated in the literature [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare OR time, hospital stay, blood loss, return to ROM, KSS, activity level, adverse event rates, and radiographic data to UKA and TKA as reported in the literature. [ Time Frame: Immediate post-op through 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 184
Study Start Date: December 2009
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Triathlon PKR
All subjects enrolled will receive the Triathlon PKR device.
Device: Triathlon PKR
Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee.

  Eligibility

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is a male or non-pregnant female 21-75 years of age at the time of enrollment.
  • The subject requires a primary cemented unicompartmental knee replacement.
  • The subject has a diagnosis of osteoarthritis (OA) or posttraumatic arthritis (TA).
  • The subject has clinically intact cruciate and collateral ligaments and no ligamentous instability is present.
  • The subject has less than 10 degrees of flexion contracture and greater than 90 degrees of flexion.
  • The subject's preoperative mechanical alignment is less than 10 degrees of varus and 10 degrees of valgus.
  • 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 Criteria:

  • The subject has inflammatory arthritis or avascular necrosis(AVN).
  • The subject is obese, BMI > 35.
  • The subject has a history of total or unicompartmental (contralateral compartment and/or patellofemoral joint) reconstruction of the affected joint.
  • The subject has a history of ACL reconstruction.
  • The subject has had a high distal femoral, or proximal tibial osteotomy.
  • The subject has a mental, neuromuscular or neurosensory disorder, which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in post-operative care and/or limit the ability to assess the performance of the device.
  • The subject has a systemic or metabolic disorder leading to progressive bone deterioration that the surgeon feels would affect the overall outcome of the study.
  • The subject is immunologically suppressed, or is receiving chronic steroids (>30 days duration).
  • The subject has a known sensitivity to device materials.
  • The subject's bone stock is compromised by disease and/or infection which cannot provide adequate support and/or fixation to the prosthesis.
  • The subject's bone stock is compromised by a prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
  • The subject has an active or suspected latent infection in or about the knee joint.
  • The subject is a prisoner.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00966979

Contacts
Contact: Michael Howard 201-831-5807 michael.howard@stryker.com
Contact: Catherine Vanacore 201-831-5893 catherine.vanacore@stryker.com

Locations
United States, Florida
Heekin Orthopaedic Institute for Research, Inc. Recruiting
Jacksonville, Florida, United States, 32204
Contact: Julie Sacerdote    904-674-2017    jsacerdote@heekinortho.com   
Principal Investigator: R. David Heekin, M.D.         
United States, Illinois
Bonutti Clinic Recruiting
Effingham, Illinois, United States, 62401
Contact: Jodi Locey    217-342-3400      
Principal Investigator: Peter Bonutti, MD         
United States, New Jersey
Rothman Institute Recruiting
Egg Harbor Township, New Jersey, United States, 08234
Contact: Victoria Younger    609-677-7015    victoria.younger@rothmaninstitute.com   
Contact: Ann Marie Madden    609-407-6446    annemarie.madden@rothmaninstitute.com   
Principal Investigator: Fabio Orozco, MD         
Sub-Investigator: Zachary Post, MD         
United States, New York
Department of Orthopaedic Surgery, Kaleida Health, Buffalo General Hospital Recruiting
Buffalo, New York, United States, 14203
Contact: Mary Bayers-Thering    716-859-1253    mbayers-thering@kaleidahealth.org   
Principal Investigator: Matthew Phillips, MD         
Sub-Investigator: Sridhar Rachala, MD         
United States, Vermont
Mansfield Orthopaedics Recruiting
Morrisville, Vermont, United States, 05661
Contact: Leah Morse, MS, PA-C    802-888-8405    lemorse@CHSI.org   
Principal Investigator: Bryan Huber, MD         
Germany
Praxisklinik Stollberg und Arthro. Zentrum GmbH Recruiting
Stollberg, Germany, 09366
Contact: Britta von den Brincken    + 49 2065 837-552    Britta.vondenBrincken@stryker.com   
Contact: Marco Tinius, MD    49+ (0) 37296/92660    m.tinius@praxisklinik-stollberg.de   
Principal Investigator: Marco Tinius, MD         
Italy
Presidlo Ospedaliero Civile Santi Antonio e Biagio Terminated
Alessandria, Italy, 15100
Sponsors and Collaborators
Stryker Orthopaedics
Investigators
Principal Investigator: R. David Heekin, M.D. St. Vincent's Medical Center
Principal Investigator: Marco Tinius, MD Praxisklinik Stollberg
Principal Investigator: Marco Schiraldi, MD Presidlo Ospedaliero Civile Santi Antonio e Biagio
Principal Investigator: Bryan Huber, MD Mansfield Orthopaedics
Principal Investigator: Fabio Orozco, MD Rothman Institute
Principal Investigator: Mathew Phillips, MD Department of Orthopaedic Surgery, Kaleida Health, Buffalo General Hospital
Principal Investigator: Peter Bonutti, MD Bonutti Clinic
  More Information

No publications provided

Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00966979     History of Changes
Other Study ID Numbers: 66
Study First Received: August 25, 2009
Last Updated: December 27, 2013
Health Authority: United States: Institutional Review Board
United Kingdom: Research Ethics Committee
Germany: Ethics Commission
Italy: Ethics Committee

Keywords provided by Stryker Orthopaedics:
Osteoarthritis, Post-traumatic arthritis

ClinicalTrials.gov processed this record on April 17, 2014