Triathlon All-Polyethylene Tibia Outcomes Study (APT)
Primary Purpose
Arthropathy of Knee, Replacement, Knee Arthritis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Triathlon All-Polyethylene Tibia Knee
Sponsored by
About this trial
This is an interventional treatment trial for Arthropathy of Knee
Eligibility 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.
Sites / Locations
- Michigan Orthopaedic CenterRecruiting
- Kaleida Health, Department of Orthopaedic Surgery, Buffalo General HospitalRecruiting
- Duke University Medical Center
- Department of Orthopaedic Surgery Cleveland ClinicRecruiting
- Musculoskeletal Institute, University of Texas Health AustinRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Triathlon All-Polyethylene Tibia Knee
Arm Description
All subjects enrolled will have received the Triathlon All-Polyethylene Tibia Knee device.
Outcomes
Primary Outcome Measures
Knee Society Score (KSS) Function
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
Kaplan-Meier Survival Analysis
To present 10-year Kaplan-Meier survival analysis for the Triathlon APT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04636190
Brief Title
Triathlon All-Polyethylene Tibia Outcomes Study
Acronym
APT
Official Title
A Retrospectively Enrolled and Prospectively Followed, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon All-Polyethylene Tibia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2, 2021 (Actual)
Primary Completion Date
January 2028 (Anticipated)
Study Completion Date
December 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stryker Orthopaedics
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the clinical functional results of the Triathlon All-Polyethylene Tibia Knee Device.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy of Knee, Replacement, Knee Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
204 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Triathlon All-Polyethylene Tibia Knee
Arm Type
Other
Arm Description
All subjects enrolled will have received the Triathlon All-Polyethylene Tibia Knee device.
Intervention Type
Device
Intervention Name(s)
Triathlon All-Polyethylene Tibia Knee
Intervention Description
Triathlon All-Polyethylene Tibia Knee is an all polyethylene resurfacing knee device using either a condylar stabilizing (CS) and posterior stabilizing (PS) device.
Primary Outcome Measure Information:
Title
Knee Society Score (KSS) Function
Description
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.
Time Frame
10-years postoperative
Secondary Outcome Measure Information:
Title
Kaplan-Meier Survival Analysis
Description
To present 10-year Kaplan-Meier survival analysis for the Triathlon APT
Time Frame
10-years postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rushal Parikh
Phone
201-745-0310
Email
rushal.parikh@stryker.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lorie Gardner
Phone
201-831-5491
Email
lorie.gardner@stryker.com
Facility Information:
Facility Name
Michigan Orthopaedic Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Wesley Mesko, M.D.
Facility Name
Kaleida Health, Department of Orthopaedic Surgery, Buffalo General Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shridhar Rachala, M.D
First Name & Middle Initial & Last Name & Degree
Matthew Phillips, M.D.
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27703
Country
United States
Individual Site Status
Terminated
Facility Name
Department of Orthopaedic Surgery Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trevor Murray, M.D.
Facility Name
Musculoskeletal Institute, University of Texas Health Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karl Koenig, M.D
12. IPD Sharing Statement
Learn more about this trial
Triathlon All-Polyethylene Tibia Outcomes Study
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