Exactech Knee Systems Post Market Clinical Follow-up
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Eric L Rohrs, PhD · STUDY_DIRECTOR · Exactech
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Primary Objective10 Years
The objective of this study is to assess the safety and performance of Exactech Knee System devices. Data will be collected to provide objective evidence of safety and performance of Exactech Knee Systems used in primary knee arthroplasty. Data may be analyzed to support future presentations and publications of an Exactech Knee System and may be used to provide clinical evidence of the post market outcomes of Exactech Knee Systems to regulatory authorities when required. The following data will be collected: Demographics (e.g., height, weight, age, and gender), Preoperative information (e.g., indication for surgery, comorbidities, pre-surgical assessments of knee function), Operative details (e.g., intra-operative findings, surgical approach, length of surgery), Product information (components used in the knee surgery), Adverse events (e.g., infection, device failure, revision), Implant survivorship, \& Patient Reported Outcomes (KOOS, KSS, HSS, OKS and/or VAS)