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| Name | Class |
|---|---|
| Ortho IFC LLC | UNKNOWN |
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Interferential Current Therapy (IFC) is a form of electrical therapy that utilizes two simultaneous low frequency electrical stimulation which when they cross interfere with one another resulting in an interference or beat frequency. This beat frequency provides a therapeutic area of relief by blocking painful stimuli at the area of interest. IFC is different from the other electrical treatment modalities used because the cancellation effect allows for establishment of the treatment area to be in the deeper tissues of the body, whereas other electrical modalities can only be used to treat superficial body parts that lie just under the skin.
The main objective of this proposed study is to assess the post-operative short term outcomes of the patients who receive IFC treatment during their post-total knee arthroplasty (TKA) surgery hospital stay. The implications of the study would be improved patient outcome which could result in shorter hospital stay, reduced use of opioid medication, decreased need for manipulation under anesthesia and reduced re-admission rate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IFC Treatment | Experimental | The IFC treatment will be used for 30 minutes, twice a day for two days after the total knee arthroplasty |
|
| Placebo | Placebo Comparator | One set of device is programmed to be used as Placebo, the subject will feel the vibration but will not receive a therapeutic signal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferential Current Therapy | Device | IFC treatment after Total Knee Arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Opioid Pain Medication Usage | Post-operative opioid pain medication usage was assessed by tabulating opioid use during the hospital stay after Total Knee Arthroplasty (TKA) as determined by median morphine milligram equivalents (MME). | 24 hours after surgery |
| Post-operative Opioid Pain Medication Usage | Post-operative opioid pain medication usage was assessed by tabulating opioid use during the hospital stay after Total Knee Arthroplasty (TKA) as determined by median MME (morphine milligram equivalents). | 48 hours after surgery |
| Visual Pain Score (VAS) | VAS asks a patient to mark a place on a scale that aligns with their level of pain smiley face 0=No pain - sad face 10=worst pain | 24 Hours after surgery |
| Visual Pain Score | VAS asks a patient to mark a place on a scale that aligns with their level of pain smiley face 0=No pain - sad face 10=worst pain | 48 Hours after surgery |
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Inclusion Criteria:Adult patients with knee osteoarthritis who have failed conservative therapy and undergoing elected TKA.
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Exclusion Criteria:
i. <18 years old ii. Any patient with pacemaker or any electrical stimulator device iii. Patients without capacity to consent for the study iv. Patients not able to have local nerve block or spinal anesthesia v. Patients with prior chronic opioid use vi. Patients who are categorized to have 'Severe' fear and anxiety responses to pain, according to the Pain catastrophizing scale (PCS) survey.
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| Name | Affiliation | Role |
|---|---|---|
| Zeynep Seref-Ferlengez, PhD | Albert Einstein College of Medicine | Principal Investigator |
| Sun Jin Kim, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
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While forty-two (42) participants were consented, two of the consented participants never had surgery (one participant due to COVID-related restrictions and one participant on account of changing their mind) and thus were never enrolled/randomized into the study and thus 40 participants were considered to have been enrolled/randomized for purposes of analysis. Twenty into each arm/group
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| ID | Title | Description |
|---|---|---|
| FG000 | IFC Treatment | The IFC treatment will be used for 30 minutes, twice a day for two days after the total knee arthroplasty Interferential Current Therapy: IFC treatment after Total Knee Arthroplasty |
| FG001 | Placebo | One set of device is programmed to be used as Placebo, the subject will feel the vibration but will not receive a therapeutic signal. Interferential Current Therapy: IFC treatment after Total Knee Arthroplasty |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline data provided for all 40 participants who were officially enrolled into the study. 20 participants per arm/group
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| ID | Title | Description |
|---|---|---|
| BG000 | IFC Treatment | The IFC treatment will be used for 30 minutes, twice a day for two days after the total knee arthroplasty Interferential Current Therapy: IFC treatment after Total Knee Arthroplasty |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-operative Opioid Pain Medication Usage | Post-operative opioid pain medication usage was assessed by tabulating opioid use during the hospital stay after Total Knee Arthroplasty (TKA) as determined by median morphine milligram equivalents (MME). | Posted | Median | Inter-Quartile Range | MME | 24 hours after surgery |
|
3 months
Adverse Event/Serious Adverse Events/Mortality was evaluated for the 17 participants in each arm/group who received the treatment or placebo
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IFC Treatment | The IFC treatment will be used for 30 minutes, twice a day for two days after the total knee arthroplasty Interferential Current Therapy: IFC treatment after Total Knee Arthroplasty |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Director | Joint Replacement Center of Montefiore Medical Center | 9292466352 | sereffer@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 3, 2019 | Aug 8, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 3, 2019 | Aug 8, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| Protocol Violation |
|
One set of device is programmed to be used as Placebo, the subject will feel the vibration but will not receive a therapeutic signal.
Interferential Current Therapy: IFC treatment after Total Knee Arthroplasty
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Post-operative Opioid Pain Medication Usage | Post-operative opioid pain medication usage was assessed by tabulating opioid use during the hospital stay after Total Knee Arthroplasty (TKA) as determined by median MME (morphine milligram equivalents). | Posted | Median | Inter-Quartile Range | MME | 48 hours after surgery |
|
|
|
| Primary | Visual Pain Score (VAS) | VAS asks a patient to mark a place on a scale that aligns with their level of pain smiley face 0=No pain - sad face 10=worst pain | Posted | Median | Inter-Quartile Range | score on a scale | 24 Hours after surgery |
|
|
|
| Primary | Visual Pain Score | VAS asks a patient to mark a place on a scale that aligns with their level of pain smiley face 0=No pain - sad face 10=worst pain | Posted | Median | Inter-Quartile Range | score on a scale | 48 Hours after surgery |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Placebo | One set of device is programmed to be used as Placebo, the subject will feel the vibration but will not receive a therapeutic signal. Interferential Current Therapy: IFC treatment after Total Knee Arthroplasty | 0 | 17 | 0 | 17 | 0 | 17 |
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