Prospective Trial of the TriFit™ Web Knee Brace

NCT03633071 | Terminated

• 1 other identifier: JS - Trifit -001
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Visual Analogue Scale (VAS) (measures pain)

  Baseline (screening) and compare at specific timepoints until 12 months

• Activity Restriction Scores

  up to12 month period

• Patient Satisfaction with Brace

  up to 12 month course of study

• Analgesic use

  up to12 month course of the study

• Compliance

  up to 12 month course of the study

Interventions

Web-knee brace OTHER

Web -Knee Brace

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age \> 21 years;
• BMI \< 40;
• Medial or lateral knee Osteoarthritis as clinical diagnosis \[Kellgren-Lawrence grades 1-3 Osteoarthritis\];
• Persistent knee pain beyond current treatment;
• No history of corticosteroid injection or viscosupplementation injections in the last 3 months;
• Able to comply with study requirements;
• Capable and willing of signing informed consent.

You may not qualify if:

• Age \< 21 years;
• History of diabetic neuropathy;
• History of traumatic onset of knee pain;
• Undergone surgery on either lower limb within 6 months;
• Unable to comply with study requirements;
• Had previously received corticosteroid injections or viscosupplementation injections in the affected knee within 3 months of study;
• KL grade \>3

Sponsors & Collaborators

• Foundation for Orthopaedic Research and Education: lead
• DJO Incorporated: collaborator

Study Sites (1)

Florida Orthopaedic Institute

Tampa, Florida, 33637, United States

Location

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jeff E Sellman, MD

  Florida Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: August 16, 2018
• Study Start: February 12, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

US (1)