Triathlon® Partial Knee Replacement (PKR) Outcomes Study

NCT ID: NCT00966979

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2023-05-31

Brief 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.

Conditions

Arthroplasty, Replacement, Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Triathlon PKR

All subjects enrolled will receive the Triathlon PKR device.

Group Type: OTHER

Triathlon PKR

Intervention Type: DEVICE

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

Interventions

Triathlon PKR

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Orthopaedics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

R. David Heekin, M.D.

Role: PRINCIPAL_INVESTIGATOR

St. Vincent's Medical Center

Marco Tinius, MD

Role: PRINCIPAL_INVESTIGATOR

Praxisklinik Stollberg

Marco Schiraldi, MD

Role: PRINCIPAL_INVESTIGATOR

Presidlo Ospedaliero Civile Santi Antonio e Biagio

Brian Aros, MD

Role: PRINCIPAL_INVESTIGATOR

Mansfield Orthopaedics

Fabio Orozco, MD

Role: PRINCIPAL_INVESTIGATOR

Rothman Institute

Matthew Phillips, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Orthopaedic Surgery, Kaleida Health, Buffalo General Hospital

Peter Bonutti, MD

Role: PRINCIPAL_INVESTIGATOR

Bonutti Clinic

Soren Toksvig-Larsen, MD

Role: PRINCIPAL_INVESTIGATOR

Hassleholm Sygehus Ortopaedkirurgisk afd.

Brett Greenky, MD

Role: PRINCIPAL_INVESTIGATOR

Syracuse Orthopedic Specialists

Paul Jacob, MD

Role: PRINCIPAL_INVESTIGATOR

Oklahoma Sports Science and Orthopaedics

Locations

Heekin Orthopaedic Institute for Research, Inc.

Jacksonville, Florida, United States

Rothman Institute

Egg Harbor, New Jersey, United States

Department of Orthopaedic Surgery, Kaleida Health, Buffalo General Hospital

Buffalo, New York, United States

Syracuse Orthopedic Specialists

Syracuse, New York, United States

Rothman Institute

Media, Pennsylvania, United States

Mansfield Orthopaedics

Morrisville, Vermont, United States

Praxisklinik Stollberg und Arthro. Zentrum GmbH

Stollberg, , Germany

Presidlo Ospedaliero Civile Santi Antonio e Biagio

Alessandria, , Italy

Hassleholm Sygehus Ortopaedkirurgisk afd. Esplanadgatan

Hässleholm, , Sweden

Countries

United States; Germany; Italy; Sweden

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

66

Identifier Type: -

Identifier Source: org_study_id