Knee OsteoarthritisNCT03840096
Effectiveness of BREG Flex in 12-week Peri-operative Total Knee Arthroplasty
A study testing Breg Flex in people with Knee Osteoarthritis, run by The Hawkins Foundation at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Breg Flex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2018to 15 Jun 2021
- Phase
- Interventional
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who are scheduled for Total Knee Arthroplasty by a single surgeon (Burnikel)
- Individuals who are at least 55 years of age
- Individuals with a body mass index (BMI) <45
- Must be able and willing to complete all study assessments and to be followed for the full course of the study.
- Must be able to read, write and follow instructions in English.
- Must be able and willing to provide informed consent.
- Must be willing and able to attend the pre-op assessment
Who cannot join
- Individuals with a history of any underlying neurological conditions
- Individuals with a history of stroke
- Individuals with a history of neurological disorder that affects lower extremity function (stroke, peripheral neuropathy, Parkinson's disease, multiple sclerosis, etc.)
- Individuals with physical conditions which would make them unable to perform study procedures
- Pregnant women or inadequate precautions to prevent pregnancy
- Diagnosis of a medical condition that would contraindicate treatment with the product, e.g. skin lesions at electrode site.
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- Individuals with a diagnosis of inflammatory arthritis (Rheumatoid arthritis, gout or psoriatic arthritis)?
- Individuals with muscle diseases (i.e. muscular dystrophy)
- Visible skin injury or disease on their legs
- Principal investigator for this study, or member of study staff
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ATI Physical Therapy
Greenville, South Carolina, 29615
Steadman Hawkins Clinic of the Carolinas - Greenville Health System
Greenville, South Carolina, 29615
About this study
Official title: Effect of Augmenting a Standard Total Knee Pathway Protocol With a 12-week Peri-Operative Program of BREG Flex
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
- Knee Osteoarthritis
- Being tested
- Breg Flex
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breg FlexDevice
All subjects in the treatment group will receive quadriceps Neuro Muscular Electrical Stimulation using Breg Flex device on the affected leg to guide and monitor of knee HEP during the 6 weeks prior to surgery and 12 weeks following surgery.
| Study group | Role | What they receive |
|---|---|---|
| Quadriceps NMES using Breg Flex | Experimental | Not described Receives: Device: Breg Flex |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Acceptable Symptoms State (PASS)
Patient reported outcome recording patient satisfaction with level of recovery. Patients report that they are either satisfied or not.
Measured: 52 weeks post op
Secondary outcomes (4)
Knee Osteoarthritis Outcome Score-JR (KOOS-JR)
Patient reported outcome measuring knee joint specific pain and physical function. The answer values range from none to extreme to describe pain and physical limitation.
Measured: 6 week and 1 week preoperatively and 3 ,6, 12, 52 week post op
Number of Participant Physical Therapy Visits
The number of Physical therapy visits between data collection time points
Measured: 3 ,6, 12, 52 week post op
Range of motion
Passive flexion and extension range of motion of knee
Measured: 6 week and 1 week preoperatively and 3 ,6, 12 week post op
Strength
Strength of quadriceps as measured on Biodex
Measured: 6 week and 1 week preoperatively and 3 ,6, 12 week post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Jun 2018
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hawkins Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- BREG, Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840096
- Sponsor's protocol ID
- Pro00075229
- Status last verified
- Sep 2021
- First submitted
- 11 Feb 2019
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Augmenting a Standard Total Knee Pathway Protocol With a 12-week Peri-Operative Program of BREG Flex
- ClinicalTrials.gov ID
- NCT03840096
- Acronym / sponsor ID
- Pro00075229
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Hawkins FoundationUniversity, hospital or other
- Collaborators
- BREG, Inc
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 15 Feb 2019 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadriceps NMES using Breg Flex | Experimental | Device: Breg Flex |
| Control | No intervention | – |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals who are scheduled for Total Knee Arthroplasty by a single surgeon (Burnikel)
- Individuals who are at least 55 years of age
- Individuals with a body mass index (BMI) <45
- Must be able and willing to complete all study assessments and to be followed for the full course of the study.
- Must be able to read, write and follow instructions in English.
Key exclusion criteria (10 listed)
- Individuals with a history of any underlying neurological conditions
- Individuals with a history of stroke
- Individuals with a history of neurological disorder that affects lower extremity function (stroke, peripheral neuropathy, Parkinson's disease, multiple sclerosis, etc.)
- Individuals with physical conditions which would make them unable to perform study procedures
- Pregnant women or inadequate precautions to prevent pregnancy
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 |
|---|---|---|
| Breg FlexAll subjects in the treatment group will receive quadriceps Neuro Muscular Electrical Stimulation using Breg Flex device on the affected leg to guide and monitor of knee HEP during the 6 weeks prior to surgery and 12 weeks following surgery. | Device | Quadriceps NMES using Breg Flex |
Primary outcome
Patient Acceptable Symptoms State (PASS)
Time frame: 52 weeks post op
Patient reported outcome recording patient satisfaction with level of recovery. Patients report that they are either satisfied or not.
4 secondary outcomes
Knee Osteoarthritis Outcome Score-JR (KOOS-JR)
Time frame: 6 week and 1 week preoperatively and 3 ,6, 12, 52 week post op
Number of Participant Physical Therapy Visits
Time frame: 3 ,6, 12, 52 week post op
Range of motion
Time frame: 6 week and 1 week preoperatively and 3 ,6, 12 week post op
Strength
Time frame: 6 week and 1 week preoperatively and 3 ,6, 12 week post op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breg Flex in people with Knee Osteoarthritis, run by The Hawkins Foundation at 2 sites 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 10 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: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient Acceptable Symptoms State (PASS) (time frame: 52 weeks post op). 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 9 Sep 2021.