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

  • STATUS
    Recruiting
  • End date
    Jan 29, 2029
  • participants needed
    175
  • sponsor
    Stryker Orthopaedics
Updated on 29 July 2022
osteoarthritis
total knee replacement
arthritis
partial knee replacement

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.

Details
Condition Arthroplasty, Replacement, Knee
Treatment Triathlon PKR
Clinical Study IdentifierNCT00966979
SponsorStryker Orthopaedics
Last Modified on29 July 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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