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

August 16, 2023 updated by: Stryker Orthopaedics

A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Partial Knee Resurfacing (PKR) Unicondylar Knee System

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.

Study Overview

Status

Terminated

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Stollberg, Germany, 09366
        • Praxisklinik Stollberg und Arthro. Zentrum GmbH
      • Alessandria, Italy, 15100
        • Presidlo Ospedaliero Civile Santi Antonio e Biagio
      • Hässleholm, Sweden
        • Hassleholm Sygehus Ortopaedkirurgisk afd. Esplanadgatan
    • Florida
      • Jacksonville, Florida, United States, 32204
        • Heekin Orthopaedic Institute for Research, Inc.
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • Rothman Institute
    • New York
      • Buffalo, New York, United States, 14203
        • Department of Orthopaedic Surgery, Kaleida Health, Buffalo General Hospital
      • Syracuse, New York, United States, 13214
        • Syracuse Orthopedic Specialists
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Rothman Institute
    • Vermont
      • Morrisville, Vermont, United States, 05661
        • Mansfield Orthopaedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Triathlon PKR
All subjects enrolled will receive the Triathlon PKR device.
Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigation of Clinical Performance and Patient Outcome With the Functional Knee Society Score (KSS).
Time Frame: 10 years

The Knee Society Score (KSS) consists of two distinct sub-scores: one for pain, range of motion, joint stability and alignment (Pain/Motion KSS) and one for distance walked, stair climbing and walking aids (Functional KSS).

This outcome measure was only for the KSS Function Score at 10-years. The KSS Function score subscale is 0-100, with 100 representing a better outcome. Although the specific scores are not distinguished as "excellent", "good", "fair", or "poor", a higher value represents a better outcome.

10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
10-years Kaplan Meier Survival Analysis
Time Frame: 10-years
For the purpose of this study the Kaplan-Meier survival curves are a statistical method to estimate the survival function from lifetime data of a knee replacement after treatment. Survivorship is defined as a percentage of knees free of any component revision for any reason.
10-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

August 25, 2009

First Submitted That Met QC Criteria

August 25, 2009

First Posted (Estimated)

August 27, 2009

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 66

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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