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A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak Knee System
Patient outcomes data is important for assessing the post-market safety and effectiveness of orthopedic medical devices. The purpose of this study is to collect clinical and patient outcomes and survivorship data for patients who have received or will receive a Optetrak® knee prosthesis manufactured or distributed by Exactech Inc (Gainesville, Florida, USA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enrolled Subjects | Patients recruited from the population undergoing knee arthroplasty as part of standard of care. Patients who meet all the inclusion criteria and none of the exclusion criteria should be presented with an opportunity to undergo the informed consent process. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optetrak Total Knee System | Device | Total Knee Arthroplasty using Exactech's Optetrak branded components. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score | (KSS) - validated outcome score | Preoperative |
| Knee Society Score | (KSS) - validated outcome score | 6 month postoperative |
| Knee Society Score | (KSS) - validated outcome score | annually through study completion, maximum of 10-years |
| Hospital for Special Surgery Knee Score | (HSS) - validated outcome score | Preoperative |
| Hospital for Special Surgery Knee Score | (HSS) - validated outcome score | 6 month postoperative |
| Hospital for Special Surgery Knee Score | (HSS) - validated outcome score | annually through study completion, maximum of 10-years |
| Oxford Knee Score | (OKS) - validated outcome score | Preoperative |
| Oxford Knee Score | (OKS) - validated outcome score | 6 month postoperative |
| Oxford Knee Score |
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Inclusion Criteria:
Exclusion Criteria:
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Patients must qualify for surgery per indications and contraindications as well as meet all the inclusion criteria and none of the exclusion criteria. The decision to offer a patient enrollment in this study is left to the discretion of the surgeon.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fallon Clinic | Worcester | Massachusetts | 01608 | United States | ||
| Nevada Orthopaedic and Spine Center |
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(OKS) - validated outcome score
| annually through study completion, maximum of 10-years |
| Las Vegas |
| Nevada |
| 89128 |
| United States |
| Medical University South Carolina | Charleston | South Carolina | 29425 | United States |