Triathlon® Partial Knee Replacement (PKR) Outcomes Study
Stopped: Enrollment goals not being met.
United States111 participantsStarted 2010-01
Plain-language 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.
Who can participate
Age range21 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 th…
What they're measuring
1
Investigation of Clinical Performance and Patient Outcome With the Functional Knee Society Score (KSS).