Optetrak Knee System Post Market Clinical Follow-Up
Study Details
Study Description
Brief Summary
A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak Knee System
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Device: Optetrak Total Knee System
Total Knee Arthroplasty using Exactech's Optetrak branded components.
|
Outcome Measures
Primary Outcome Measures
- Knee Society Score [Preoperative]
(KSS) - validated outcome score
- Knee Society Score [6 month postoperative]
(KSS) - validated outcome score
- Knee Society Score [annually through study completion, maximum of 10-years]
(KSS) - validated outcome score
- Hospital for Special Surgery Knee Score [Preoperative]
(HSS) - validated outcome score
- Hospital for Special Surgery Knee Score [6 month postoperative]
(HSS) - validated outcome score
- Hospital for Special Surgery Knee Score [annually through study completion, maximum of 10-years]
(HSS) - validated outcome score
- Oxford Knee Score [Preoperative]
(OKS) - validated outcome score
- Oxford Knee Score [6 month postoperative]
(OKS) - validated outcome score
- Oxford Knee Score [annually through study completion, maximum of 10-years]
(OKS) - validated outcome score
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient is indicated for knee replacement, or has already undergone knee replacement, with a device manufactured or distributed by Exactech
-
Patient is skeletally mature
-
Patient meets the indications detailed in the applicable product package insert Patient is willing and able to review and sign an informed consent form, if necessary
Exclusion Criteria:
-
Patient has a local or systemic infection
-
Patient has a known sensitivity to one or more of the materials in the knee replacement system to be used
-
Patient is pregnant
-
Patient has a mental or physical condition that may invalidate evaluation of the data
-
Patient is a prisoner
-
Surgery is contraindicated according to the applicable product package insert
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fallon Clinic | Worcester | Massachusetts | United States | 01608 |
| 2 | Nevada Orthopaedic and Spine Center | Las Vegas | Nevada | United States | 89128 |
| 3 | Medical University South Carolina | Charleston | South Carolina | United States | 29425 |
Sponsors and Collaborators
- Exactech
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR05-007