Prospective Trial of the TriFit™ Web Knee Brace

Terminated

• Conditions: Satisfaction

• Registration Number: NCT03633071
• Lead Sponsor: Foundation for Orthopaedic Research and Education

Brief 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.

Study Timeline

• Study First Submitted: 2017-11-07
• Study Start: 2018-02-12
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-16
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-03
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score	up to12 months	- The KOOS Jr. survey is a self-reported questionnaire (7 questions) designed to measure "knee health" as it reflects aspects of pain, symptom severity, and activities of daily living (ADL) including movement or activities that are directly relevant and difficult for patients with knee OA. A short-form knee arthroplasty outcomes survey.

Secondary Outcome Measures

Name	Time	Method
Activity Restriction Scores	up to12 month period	-A scale from 1-100, 1 being no activity, and 100 being active
Analgesic use	up to12 month course of the study	Analgesic use for Knee pain, medications, Injections - to document subjects pain
Compliance	up to 12 month course of the study	Compliance - to document how many hours the brace is worn
Visual Analogue Scale (VAS) (measures pain)	Baseline (screening) and compare at specific timepoints until 12 months	- A short-form to measure pain level knee arthroplasty outcomes survey. The scale is from 1-100 on a 10cm ruler, the higher the number equals more pain.
Patient Satisfaction with Brace	up to 12 month course of study	Satisfaction is measured by 5 choices, very dissatisfied, dissatisfied, not dissatisfied or satisfied, satisfied, very satisfied.

Trial Locations

Locations (1)

Florida Orthopaedic Institute; 🇺🇸 Tampa, Florida, United States