SatisfactionNCT03633071
Prospective Trial of the TriFit™ Web Knee Brace
An observational study of Satisfaction, run by Foundation for Orthopaedic Research and Education at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Satisfaction
- What is being tested?
- Web-knee brace
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2018to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Satisfaction
- Being tested
- Web-knee brace
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-knee braceOther
Web -Knee Brace
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to12 months
Secondary outcomes (5)
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.
Measured: 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
Measured: up to12 month period
Patient Satisfaction with Brace
Satisfaction is measured by 5 choices, very dissatisfied, dissatisfied, not dissatisfied or satisfied, satisfied, very satisfied.
Measured: up to 12 month course of study
Analgesic use
Analgesic use for Knee pain, medications, Injections - to document subjects pain
Measured: up to12 month course of the study
Compliance
Compliance - to document how many hours the brace is worn
Measured: up to 12 month course of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start12 Feb 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Orthopaedic Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- DJO Incorporated
- Responsible party
- Sponsor
- Investigators
- Jeff E Sellman, MD, Principal investigator, Florida Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633071
- Sponsor's protocol ID
- JS - Trifit -001
- Status last verified
- Feb 2020
- First submitted
- 7 Nov 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Outcomes of IPD
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03633071
- Acronym / sponsor ID
- JS - Trifit -001
- Conditions
- Satisfaction
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Foundation for Orthopaedic Research and EducationUniversity, hospital or other
- Collaborators
- DJO Incorporated
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web-knee braceWeb -Knee Brace | Other | – |
Primary outcome
Knee Injury and Osteoarthritis Outcome Score
Time frame: 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.
5 secondary outcomes
Visual Analogue Scale (VAS) (measures pain)
Time frame: Baseline (screening) and compare at specific timepoints until 12 months
Activity Restriction Scores
Time frame: up to12 month period
Patient Satisfaction with Brace
Time frame: up to 12 month course of study
Analgesic use
Time frame: up to12 month course of the study
Compliance
Time frame: up to 12 month course of the study
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: Undecided. Outcomes of IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff E Sellman, MD principal investigator
Florida Orthopaedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Satisfaction, run by Foundation for Orthopaedic Research and Education at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Injury and Osteoarthritis Outcome Score (time frame: up to12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.