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

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.

Study Overview

• Status: Terminated
• Conditions: Satisfaction
• Intervention / Treatment: Other: Web-knee brace

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 Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33637
      • Florida Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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 seen in the Principal Investigator's outpatient clinic at Florida Orthopaedic Institute. The patient will still be followed clinically for 12 months after initial brace application and per the schedule of assessments as described below.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Injury and Osteoarthritis Outcome Score	- 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.	up to12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) (measures pain)	- 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.	Baseline (screening) and compare at specific timepoints until 12 months
Activity Restriction Scores	-A scale from 1-100, 1 being no activity, and 100 being active	up to12 month period
Patient Satisfaction with Brace	Satisfaction is measured by 5 choices, very dissatisfied, dissatisfied, not dissatisfied or satisfied, satisfied, very satisfied.	up to 12 month course of study
Analgesic use	Analgesic use for Knee pain, medications, Injections - to document subjects pain	up to12 month course of the study
Compliance	Compliance - to document how many hours the brace is worn	up to 12 month course of the study

Collaborators and Investigators

• Sponsor: Foundation for Orthopaedic Research and Education
• Collaborators: DJO Incorporated
• Investigators: Principal Investigator: Jeff E Sellman, MD, Florida Orthopaedic Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2018
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: November 7, 2017
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 3, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: JS - Trifit -001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Outcomes of IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No