- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00966979
Triathlon® Partial Knee Replacement (PKR) Outcomes Study (PKR)
A Prospective, Post-market, Multi-center Study of the Outcomes of the Triathlon® Partial Knee Resurfacing (PKR) Unicondylar Knee System
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Stollberg, Germany, 09366
- Praxisklinik Stollberg und Arthro. Zentrum GmbH
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Alessandria, Italy, 15100
- Presidlo Ospedaliero Civile Santi Antonio e Biagio
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Hässleholm, Sweden
- Hassleholm Sygehus Ortopaedkirurgisk afd. Esplanadgatan
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Florida
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Jacksonville, Florida, United States, 32204
- Heekin Orthopaedic Institute for Research, Inc.
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New Jersey
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Egg Harbor Township, New Jersey, United States, 08234
- Rothman Institute
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New York
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Buffalo, New York, United States, 14203
- Department of Orthopaedic Surgery, Kaleida Health, Buffalo General Hospital
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Syracuse, New York, United States, 13214
- Syracuse Orthopedic Specialists
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Pennsylvania
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Media, Pennsylvania, United States, 19063
- Rothman Institute
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Vermont
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Morrisville, Vermont, United States, 05661
- Mansfield Orthopaedics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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 |
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Other: Triathlon PKR
All subjects enrolled will receive the Triathlon PKR device.
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Triathlon PKR is a unicondylar knee resurfacing system designed to replace a single osteoarthritic compartment of a patient's natural knee.
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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
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
10-years Kaplan Meier Survival Analysis
Time Frame: 10-years
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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.
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10-years
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Collaborators and Investigators
Sponsor
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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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