Prospective Trial of the TriFit™ Web Knee Brace

Satisfaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03633071
• Other study ID #: JS - Trifit -001
• Status: Terminated
• Start date: February 12, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: February 2020
• Source: Foundation for Orthopaedic Research and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Satisfaction

Intervention

Other:
• Web-knee brace
Web -Knee Brace

Locations

Country	Name	City	State
United States	Florida Orthopaedic Institute	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Foundation for Orthopaedic Research and Education	DJO Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Activity Restriction Scores	-A scale from 1-100, 1 being no activity, and 100 being active	up to12 month period
Secondary	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
Secondary	Analgesic use	Analgesic use for Knee pain, medications, Injections - to document subjects pain	up to12 month course of the study
Secondary	Compliance	Compliance - to document how many hours the brace is worn	up to 12 month course of the study