Clinical trial NCT03633071: Prospective Trial of the TriFit™ Web Knee Brace
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Satisfaction
Lead sponsor: Foundation for Orthopaedic Research and Education
Sponsor class: OTHER
Collaborators: name: DJO Incorporated
First posted: 2018-08-16
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: up to12 months
Secondary outcomes:
measure: Visual Analogue Scale (VAS) (measures pain)
timeFrame: Baseline (screening) and compare at specific timepoints until 12 months
measure: Activity Restriction Scores
timeFrame: up to12 month period
measure: Patient Satisfaction with Brace
timeFrame: up to 12 month course of study
measure: Analgesic use
timeFrame: up to12 month course of the study
measure: Compliance
timeFrame: up to 12 month course of the study
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Florida Orthopaedic Institute
state: Florida
Study officials:
affiliation: Florida Orthopaedic Institute
name: Jeff E Sellman, MD
role: PRINCIPAL_INVESTIGATOR
References: