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Triathlon All-Polyethylene Tibia Outcomes Study

Not Applicable
Recruiting
Conditions
Replacement
Arthropathy of Knee
Knee Arthritis
Registration Number
NCT04636190
Lead Sponsor
Stryker Orthopaedics
Brief Summary

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

Detailed Description

This study is a retrospectively enrolled, prospective evaluation of the Triathlon All-Polyethylene Tibia (APT) for patients who meet the eligibility criteria. The enrolled cases will be followed for outcomes measured to 10 years. A modular, Triathlon metal-backed tibia (MBT) and polyethylene insert construct will be used as a historical control.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
204
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Knee Society Score (KSS) Function10-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
NameTimeMethod
Kaplan-Meier Survival Analysis10-years postoperative

To present 10-year Kaplan-Meier survival analysis for the Triathlon APT

Trial Locations

Locations (6)

Michigan Orthopaedic Center

🇺🇸

Lansing, Michigan, United States

Kaleida Health, Department of Orthopaedic Surgery, Buffalo General Hospital

🇺🇸

Buffalo, New York, United States

Syracuse Orthopedic Specialists, PC

🇺🇸

Syracuse, New York, United States

Duke University Medical Center

🇺🇸

Durham, North Carolina, United States

Department of Orthopaedic Surgery Cleveland Clinic

🇺🇸

Cleveland, Ohio, United States

Musculoskeletal Institute, University of Texas Health Austin

🇺🇸

Austin, Texas, United States

Michigan Orthopaedic Center
🇺🇸Lansing, Michigan, United States
J. Wesley Mesko, M.D.
Principal Investigator

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