Have you or your loved ones been diagnosed with arthroplasty, replacement, knee?

You may be eligible to participate in a arthroplasty, replacement, knee clinical trial.

Have you or your loved ones been diagnosed with arthroplasty, replacement, knee? You may be eligible to participate in a arthroplasty, replacement, knee clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Arthroplasty, Replacement, Knee Clinical Trial

NCT00966979 | Interventional

Have you or your loved ones been diagnosed with arthroplasty, replacement, knee?

You may be eligible to participate in a arthroplasty, replacement, knee clinical trial.

Have you or your loved ones been diagnosed with arthroplasty, replacement, knee? You may be eligible to participate in a arthroplasty, replacement, knee clinical trial.

Recruiting

Male & Female

21 - 75

Years old

This study is looking to recruit 175 Participants

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.

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Details for the study

Brief Title

Triathlon® Partial Knee Replacement (PKR) Outcomes Study

Official Title

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

Brief Summary

The purpose of this study is to compare the 10-year Knee Society Score (KSS) functional <br /> results of the Triathlon PKR Unicondylar Knee to the 10-year Knee Society Score (KSS) <br /> functional results of the Triathlon Cruciate Retaining (CR) Total Knee.

Treatments and/or Procedures

Triathlon PKR

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

Study 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.