Triathlon® Partial Knee Replacement (PKR) Outcomes Study

Arthroplasty, Replacement, Knee Clinical Trial

— PKR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00966979
• Other study ID #: 66
• Status: Terminated
• Phase: N/A
• Start date: January 2010
• Est. completion date: May 2023

Study information

• Verified date: August 2023
• Source: Stryker Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 111
• Est. completion date: May 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee

Intervention

Device:
• Triathlon PKR
Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Orthopaedics

Countries where clinical trial is conducted

United States,  Germany,  Italy,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigation of Clinical Performance and Patient Outcome With the Functional Knee Society Score (KSS).	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	10-years Kaplan Meier Survival Analysis	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