Prospective Trial of the TriFit™ Web Knee Brace

This clinical study will be conducted at the Florida Orthopaedic Institute (FOI) beginning in
2017. The trial will be a prospective trial of a convenience sample of skeletally mature
patients with knee pain treated by the Principal Investigator (Jeff Sellman, MD) at Florida
Orthopaedic Institute with clinically and radiographically confirmed early stage knee
Osteoarthritis that can be managed without surgical intervention. The study population will
be defined as all adult patients (>21 years) seen by the Principal Investigator and diagnosed
with knee osteoarthritis. All patients will be independent in activities of daily living. All
patients will be seen in the Prinicpal Investigator outpatient clinic at Florida Orthopaedic
Institute. Patients will be screened as candidates for enrollment into the study and if the
patient satisfies the inclusion/exclusion criteria, a clinical research coordinator or the
study Principal Investigator will explain all essential elements of the clinical trial. If
the patient agrees to participate, the study coordinator or Principal Investigator will
obtain informed consent. The patient will still be followed clinically for 12 months after
initial brace application.

Inclusion Criteria:

1. Age > 21 years;

2. BMI < 40;

3. Medial or lateral knee Osteoarthritis as clinical diagnosis [Kellgren-Lawrence grades
1-3 Osteoarthritis];

4. Persistent knee pain beyond current treatment;

5. No history of corticosteroid injection or viscosupplementation injections in the last
3 months;

6. Able to comply with study requirements;

7. Capable and willing of signing informed consent.

Exclusion Criteria:

1. Age < 21 years;

2. History of diabetic neuropathy;

3. History of traumatic onset of knee pain;

4. Undergone surgery on either lower limb within 6 months;

5. Unable to comply with study requirements;

6. Had previously received corticosteroid injections or viscosupplementation injections
in the affected knee within 3 months of study;

7. KL grade >3