Triathlon All-Polyethylene Tibia Outcomes Study

Knee Arthritis Clinical Trial

— APT  

Official title:

A Retrospectively Enrolled and Prospectively Followed, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon All-Polyethylene Tibia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04636190
• Other study ID #: 104
• Status: Recruiting
• Phase: N/A
• Start date: July 2, 2021
• Est. completion date: December 2028

Study information

• Verified date: February 2024
• Source: Stryker Orthopaedics
• Contact: Rushal Parikh
• Phone: 201-745-0310
• Email: rushal.parikh[@]stryker.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: December 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthropathy of Knee
• Joint Diseases
• Knee Arthritis
• Replacement

Intervention

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.

Locations

Country	Name	City	State
United States	Musculoskeletal Institute, University of Texas Health Austin	Austin	Texas
United States	Kaleida Health, Department of Orthopaedic Surgery, Buffalo General Hospital	Buffalo	New York
United States	Department of Orthopaedic Surgery Cleveland Clinic	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Michigan Orthopaedic Center	Lansing	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10-years postoperative
Secondary	Kaplan-Meier Survival Analysis	To present 10-year Kaplan-Meier survival analysis for the Triathlon APT	10-years postoperative