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Triathlon All-Polyethylene Tibia Outcomes Study (APT)

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: NCT04636190
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : March 3, 2022
Sponsor:
Information provided by (Responsible Party):
Stryker Orthopaedics

Study Description
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Brief Summary:
The purpose of this study is to evaluate the clinical functional results of the Triathlon All-Polyethylene Tibia Knee Device.

Condition or disease Intervention/treatment Phase
Arthropathy of Knee Replacement Knee Arthritis Device: Triathlon All-Polyethylene Tibia Knee Not Applicable

Detailed Description:
After being informed about the study, all patients giving written consent will undergo a screening period to determine eligibility for the study. If eligibility is met, data will be obtained retrospectively from the medical records from the preoperative to shortly after surgery time period. Thereafter, the subject will be evaluated at their 5-year and 10-year post surgery anniversary date.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Retrospectively Enrolled and Prospectively Followed, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon All-Polyethylene Tibia
Actual Study Start Date : July 2, 2021
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Triathlon All-Polyethylene Tibia Knee
All subjects enrolled will have received the Triathlon All-Polyethylene Tibia Knee device.
 Device: Triathlon All-Polyethylene Tibia Knee
Triathlon All-Polyethylene Tibia Knee is an all polyethylene resurfacing knee device using either a condylar stabilizing (CS) and posterior stabilizing (PS) device.


Outcome Measures
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Primary Outcome Measures :
  1. Knee Society Score (KSS) Function [ Time Frame: 10-years postoperative ]
    The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome postoperative.


Secondary Outcome Measures :
  1. Kaplan-Meier Survival Analysis [ Time Frame: 10-years postoperative ]
    To present 10-year Kaplan-Meier survival analysis for the Triathlon APT


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusions:

  • Patient underwent primary TKA and is currently implanted with the Triathlon All- Polyethylene Tibia as well as compatible Stryker femoral and patellar components with no pending revision or removal.
  • Patient has signed an IRB-approved, study specific Informed Patient Consent Form.
  • Patient is a male or non-pregnant female and is 18 years of age or older at the time of study device implantation.
  • Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.

Exclusions:

  • Patient had an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
  • Patient had distant foci of infection which could have caused hematogenous spread to the implant site at time of study device implantation.
  • Patient was skeletally immature at time of study device implantation.
  • Patient has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
  • Patient's bone stock was compromised by disease, infection, or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
  • Patient had severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
  • Patient was immunologically suppressed or receiving steroids in excess of normal physiological requirements at the time of surgery (e.g. > 30 days).
  • Patient is a prisoner.
Contacts and Locations
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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): NCT04636190


Contacts
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Contact: Rushal Parikh 630-338-5932 rushal.parikh@stryker.com
Contact: Lorie Gardner 201-831-5491 lorie.gardner@stryker.com

Locations
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United States, Michigan
Michigan Orthopaedic Center Recruiting
Lansing, Michigan, United States, 48910
Principal Investigator: J. Wesley Mesko, M.D.         
United States, New York
Kaleida Health, Department of Orthopaedic Surgery, Buffalo General Hospital Not yet recruiting
Buffalo, New York, United States, 14203
Principal Investigator: Shridhar Rachala, M.D         
Sub-Investigator: Matthew Phillips, M.D.         
United States, North Carolina
Duke University Medical Center Not yet recruiting
Durham, North Carolina, United States, 27703
Principal Investigator: Samuel Wellman, M.D.         
United States, Ohio
Department of Orthopaedic Surgery Cleveland Clinic Not yet recruiting
Cleveland, Ohio, United States, 44195
Principal Investigator: Trevor Murray, M.D.         
United States, Texas
Musculoskeletal Institute, University of Texas Health Austin Not yet recruiting
Austin, Texas, United States, 78712
Principal Investigator: Karl Koenig, M.D         
Sponsors and Collaborators
Stryker Orthopaedics
More Information
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Responsible Party: Stryker Orthopaedics
ClinicalTrials.gov Identifier: NCT04636190    
Other Study ID Numbers: 104
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: March 3, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases