Trials / Terminated
TerminatedNCT03633071
Prospective Trial of the TriFit™ Web Knee Brace
Prospective Trial of the TriFit™ Web Knee Brace: An Evaluation of Functional Improvements and Satisfaction in Conservatively-Managed Patients With Knee Osteoarthritis Over a 12-month Period
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 4 (actual)
- Sponsor
- Foundation for Orthopaedic Research and Education · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Accepted
Summary
This is a prospective trial comparing improvements in pain, function, and quality of life in patients with early-stage knee osteoarthritis conservatively managed with the TriFit™ Web Knee Brace. The study design will represent a consecutive series of conservatively managed patients with knee-pain not yet candidates for surgical intervention and is non-comparative in nature.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Web-knee brace | Web -Knee Brace |
Timeline
- Start date
- 2018-02-12
- Primary completion
- 2019-12-01
- Completion
- 2019-12-01
- First posted
- 2018-08-16
- Last updated
- 2020-02-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03633071. Inclusion in this directory is not an endorsement.