Knee Arthroplasty, Total
Conditions
Brief summary
A Post-Market Domestic (US) and International Data Collection to Assess the Optetrak Knee System
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).
Interventions
DEVICEOptetrak Total Knee System
Total Knee Arthroplasty using Exactech's Optetrak branded components.
Sponsors
Exactech
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Society Score | Preoperative | (KSS) - validated outcome score |
| Hospital for Special Surgery Knee Score | Preoperative | (HSS) - validated outcome score |
| Oxford Knee Score | Preoperative | (OKS) - validated outcome score |
Countries
United States
Outcome results
None listed