Triathlon® Partial Knee Replacement (PKR) Outcomes Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Device: Triathlon PKR


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Post-traumatic arthritis