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Triathlon® Partial Knee Replacement (PKR) Outcomes Study (PKR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00966979
Recruitment Status : Recruiting
First Posted : August 27, 2009
Last Update Posted : May 11, 2021
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics

Brief Summary:
The purpose of this study is to compare the 10-year Knee Society Score (KSS) functional results of the Triathlon PKR Unicondylar Knee to the 10-year Knee Society Score (KSS) functional results of the Triathlon Cruciate Retaining (CR) Total Knee.

Condition or disease Intervention/treatment Phase
Arthroplasty, Replacement, Knee Device: Triathlon PKR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : January 2010
Estimated Primary Completion Date : January 2029
Estimated Study Completion Date : January 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. To compare the mean KSS Function Score at 10-years to the Triathlon Cruciate Retaining (CR) KSS Function Score at 10-years calculated combining prospective and retrospective cases. [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. A 10-year Kaplan Meier survival analysis will be presented including only prospective cases. [ Time Frame: 10 years ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 15 degrees of varus and 15 degrees of valgus.
  • The subject has signed the Institutional Review Board (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 anterior cruciate ligament (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966979


Contacts
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Contact: Lorie Gardner 201-831-5491 Lorie.Gardner@stryker.com

Locations
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United States, Florida
Heekin Orthopaedic Institute for Research, Inc. Terminated
Jacksonville, Florida, United States, 32204
United States, Illinois
Bonutti Clinic Withdrawn
Effingham, Illinois, United States, 62401
United States, New Jersey
Rothman Institute Recruiting
Egg Harbor Township, New Jersey, United States, 08234
Contact: Reynaldo McFarlane    609-677-7015    Reynaldo.McFarlane@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         
Syracuse Orthopedic Specialists Active, not recruiting
Syracuse, New York, United States, 13214
United States, Oklahoma
Oklahoma Sports Science and Orthopedics Withdrawn
Edmond, Oklahoma, United States, 73103
United States, Vermont
Mansfield Orthopaedics Recruiting
Morrisville, Vermont, United States, 05661
Contact: Stuart Sutherland, PA    802-888-8676    ssutherland@CHSI.org   
Principal Investigator: Brian Aros, MD         
Germany
Praxisklinik Stollberg und Arthro. Zentrum GmbH Active, not recruiting
Stollberg, Germany, 09366
Italy
Presidlo Ospedaliero Civile Santi Antonio e Biagio Terminated
Alessandria, Italy, 15100
Sweden
Hassleholm Sygehus Ortopaedkirurgisk afd. Esplanadgatan Recruiting
Hässleholm, Sweden
Contact: Tobias Berlin    +46 451-298734    tobias.berlin@skane.se   
Principal Investigator: Soren Toksvig-Larsen, MD         
Sponsors and Collaborators
Stryker Orthopaedics
Investigators
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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: Brian Aros, MD Mansfield Orthopaedics
Principal Investigator: Fabio Orozco, MD Rothman Institute
Principal Investigator: Matthew Phillips, MD Department of Orthopaedic Surgery, Kaleida Health, Buffalo General Hospital
Principal Investigator: Peter Bonutti, MD Bonutti Clinic
Principal Investigator: Soren Toksvig-Larsen, MD Hassleholm Sygehus Ortopaedkirurgisk afd.
Principal Investigator: Brett Greenky, MD Syracuse Orthopedic Specialists
Principal Investigator: Paul Jacob, MD Oklahoma Sports Science and Orthopaedics
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Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT00966979    
Other Study ID Numbers: 66
First Posted: August 27, 2009    Key Record Dates
Last Update Posted: May 11, 2021
Last Verified: May 2021
Keywords provided by Stryker Orthopaedics:
Osteoarthritis, Post-traumatic arthritis