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Effectiveness of BREG Flex in 12-week Peri-operative Total Knee Arthroplasty
NCT03840096 · View on ClinicalTrials.gov ↗
Study Summary
Patient outcomes following total knee replacement and standard physical therapy will be compared between subjects who use the Breg Flex study device vs those who do not. Subjects will be evaluated for knee range of motion, strength and patient reported outcomes.
Conditions Studied
Interventions
- DEVICE Breg Flex
Study Locations (2)
South Carolina
- ATI Physical Therapy — Greenville
- Steadman Hawkins Clinic of the Carolinas - Greenville Health System — Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2018-06-01 |
| Est. Completion | 2021-06-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03840096
The ClinicalTrials.gov registry entry for NCT03840096 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Hawkins Foundation, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Knee Osteoarthritis appearing as the primary indexed condition, and to 1 intervention — of which Breg Flex is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03840096 reports 2 study locations spanning 1 distinct geographic area — top geographies include South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03840096 about?
NCT03840096 is a clinical study titled "Effectiveness of BREG Flex in 12-week Peri-operative Total Knee Arthroplasty". Patient outcomes following total knee replacement and standard physical therapy will be compared between subjects who use the Breg Flex study device vs those who do not. Subjects will be evaluated for knee range of motion, strength and patient reported outcomes.
What is the current status of trial NCT03840096?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2018-06-01. Estimated completion is 2021-06-15.
What conditions does trial NCT03840096 study?
This clinical trial studies the following conditions: Knee Osteoarthritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03840096?
The interventions under investigation include: Breg Flex (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03840096?
This trial is sponsored by The Hawkins Foundation, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03840096 being conducted?
This trial has 2 study locations across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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