Clinical Outcome Study for the Triathlon Cruciate Retaining (CR) Total Knee

Study Overview
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Brief Summary
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An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System.

Detailed Description
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An open label, post-market, non-randomised, historical controlled, multi-centre study of the outcomes of the Triathlon Cruciate Retaining (CR) Total Knee System. The primary objective of this study will be to compare the active range of motion values for the Triathlon CR Total Knee System with those of the Scorpio CR Total Knee System, a historical control group. ROM values will be measured by use of a Goniometer according to the protocol. It is expected that the Triathlon CR Total Knee System group's range of motion is not 5 degrees worse or superior to the control group's range of motion at two-years.

Official Title
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Clinical Outcome Study for the Triathlon CR Total Knee

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Device: Triathlon CR Total Knee System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients willing to sign the Ethic Commission approved, study specific Informed Patient Consent Form. Patients willing and able to comply with scheduled postoperative clinical and radiographic evaluations and rehabilitation. Male or non-pregnant female between the ages of 21-80 years of age at the time of surgery. Patients requiring a primary total knee replacement. Patients with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN). Patients with intact collateral ligaments. Exclusion Criteria: Patients with inflammatory arthritis. Patients that are morbidly obese, body mass index (BMI) > 40. Patients with a history of total / unicompartmental reconstruction of the affected joint. Patients that have had a high tibial osteotomy or femoral osteotomy. Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. Patients with a systemic or metabolic disorder leading to progressive bone deterioration. Patients that are immunologically compromised, or receiving chronic steroids (>30 days duration). Patients bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. Patients with a knee fusion to the affected joint. Patients with an active or suspected latent infection in or about the knee joint. Patients with a history of total joint replacement on the opposite knee within less than 1 year. Patients requiring bilateral total knee replacement.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Triathlon CR Total Knee System<br>Primary total knee replacement | Device: Triathlon CR Total Knee System<br>* Primary total knee replacement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Triathlon CR Active Range of Motion (ROM) | Comparison of the active ROM values for patients receiving the Triathlon CR Total Knee System with historical active ROM values of the Scorpio CR Total Knee System, a control group by literature review at 2 years post Total Knee Arthroplasty. See Chaudhary R, et al 2008 JBJS included for historical control data. | 2 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigation of Patient Outcome With Radiographic Analysis | Plain radiographs will be obtained for assessment of fixation of the device. | Pre-operative, 3 months, 1, 2 and 5 years follow-up | 
| Investigation of Clinical Performance and Patient Outcome With the Knee Society Score (KSS) | The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, Range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as excellent, good, fair, or poor, a higher value represents a better outcome. | Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up | 
| Investigation of Clinical Performance and Patient Outcome With the Short Form 12 (SF-12) Patient Questionnaire | The SF-12 Health Survey is a 12-item patient completed questionnaire to measure general health and well-being. It includes a physical (PSC) and mental status component (MCS) score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. | Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up | 
| Investigation of Clinical Performance and Patient Outcome With the Western Ontario McMaster Osteoarthritis Index (WOMAC) Patient Questionnaire | The WOMAC collects information specific to osteoarthritis outcomes. The questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and physical findings. Pain is scored from 0 to 100 for each set of factors, with 0 indicating no pain and 100 indicating extreme pain. Total WOMAC scores range from 0 to 300. Lower values represent better outcomes. | Pre-operative, 3 months, 1, 2, 3, 4 and 5 years follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Replacement, Arthroplasty