Arthropathy of Knee JointNCT03044028
Neuromuscular Electrical Stimulation (NMES) for Improving Outcomes Following Total Knee Arthroplasty (TKA)
A study testing CyMedica Orthopedics QB1 e-vive™ system in people with Arthropathy of Knee Joint, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The current standard for rehabilitation after TKA consists of guided exercise therapy for up to 12 weeks after surgery. This includes inpatient, home, and outpatient therapy. The surgery and rehabilitation are highly successful at reducing or eliminating pain experienced preoperatively. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Arthropathy of Knee Joint
- What is being tested?
- CyMedica Orthopedics QB1 e-vive™ system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing unilateral primary total knee arthroplasty
- Patients who are between the ages of 18 - 85 years
- Patient has signed informed consent
- Patient has access to a smartphone or tablet (Android or iOS)
Who cannot join
- BMI ≥ 40
- Inflammatory arthritis
- Patients who are expected to be in extended care facilities after surgery
- Patients who have used an at-home NMES device in the past
- Preoperative daily use of narcotics (i.e., high tolerance)
- Already enrolled in another research study, including the present study for contralateral knee
Show all 15Show fewer
- Other lower-extremity orthopaedic conditions which could interfere with limb function, especially those with significant pain requiring daily analgesic intake
- Patients with concurrent abdominal, inguinal or femoral hernias
- Cutaneous lesions in areas of electrode pad placement
- Patients with a history of epilepsy
- Patients with a cardiac pacemaker/defibrillator
- Allergy to adhesives
- Inability to meet follow-up visits required for the study
- Patients who are a risk for poor compliance or have a poor understanding of the use of the NMES device
- Condition deemed by physician or medical staff to be non-conducive to patient's ability to complete the study, or a potential risk to the patient's health and well-being
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Neuromuscular Electrical Stimulation (NMES) for Improving Outcomes Following Total Knee Arthroplasty (TKA)
The current standard for rehabilitation after TKA consists of guided exercise therapy for up to 12 weeks after surgery. This includes inpatient, home, and outpatient therapy. The surgery and rehabilitation are highly successful at reducing or eliminating pain experienced preoperatively. However, quadriceps femoris muscle (QFM) strength, overall function, and knee range of motion are often worse than preoperative levels for as long as 6 months after surgery and in some cases may persist for many years after that. Such quadriceps strength impairments after TKA have been largely attributed to voluntary activation deficits and can lead to a decrease in functional performance such as decreased gait speed, decreased balance which can lead to falls, and decreased stair climbing \& chair rise abilities.
Since therapy alone does not adequately restore or improve upon the preoperative functional capabilities in a consistent and timely manner, it has been suggested that NMES used adjunctively with postoperative rehabilitation will alleviate the quadriceps muscle activation deficits. Early NMES use after TKA has been shown to: reduce knee extensor lag, increase walking speed, and improve QFM strength, knee range of motion, and function. However, NMES initiated one month after TKA did not lead to improved QFM strength or function beyond the standard benefits gained from exercise alone, thus suggesting that the timing of NMES application after TKA is important.
It has previously been shown that preoperative QFM strength is predictive of postoperative function [6] but the benefit of prehabilitation remains in question. To date, there has only been one pilot study assessing the benefits of NMES when initiated preoperatively. This study only included 14 patients (9 NMES, 5 control) but was able to show that preoperative NMES usage may lead to greater QFM strength gains after TKA. Therefore, it will be important to assess the benefits of NMES both preoperatively and postoperatively in order to determine how it will be most beneficial to TKA patients.
Read the detailed description
The study duration will be until 12 weeks ± 1 week postoperatively. Data will be collected (1) 4 weeks preoperatively, (2) prior to hospital admission for TKA, and (3) at 3, 6, and 12 weeks postoperatively. The research coordinator at the site will identify, recruit, and prospectively follow the 66 patients at his/her site.
All data will be entered and maintained in REDCap, an electronic data capture tools hosted at Cleveland Clinic. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies, providing 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources. Only members of the study team (i.e. the personnel listed on the institutional review board (IRB) application) will have access to protected health information of patients included in this study.
Pretreatment Assessments
Before treatment, the following assessments/tests will be performed and the results will be recorded on the appropriate pages of the (case report form) CRF, and or Microsoft excel, Microsoft Word, and REDCap:
- Informed consent
- Age, gender, height/weight/(body mass index) BMI
- Concomitant diseases
- Physical examination
- Baseline range of motion of affected knee
- Baseline timed up and go test (TUG test, detailed in Appendix A and as described by Podsiadlo et al.)
- Baseline Stair Climb test
- Baseline QFM strength
- Baseline Modified Knee Injury and Osteoarthritis Outcome Score (KOOS) and Veterans Rand 12(VR-12) assessments
- Baseline VAS (visual analog scale)pain score
- Current medications
- Any use of ambulation assist device
Presurgery Assessments
Before surgery, the following assessments/tests will be performed and the results will be recorded on the appropriate pages of the CRF, and or Microsoft excel, Microsoft Word, and REDCap:
- Device usage patterns (thru app for preop NMES group)
- Range of motion of affected knee
- TUG test
- Stair Climb test
- QFM strength
- Modified KOOS and VR-12 assessments
- VAS pain score
- Current medications
- Activity levels using Misfit Wearables® fitness monitor will be uploaded and incorporated into online app
Operative Assessments
The following will be collected from the Operative and Anesthesia Records and recorded on the appropriate pages of the CRF, and or Microsoft excel, Microsoft Word, and REDCap:
- Surgeon name
- Approach used
- Randomization assignment
- Diagnosis
- Length of surgery
- Estimated blood loss
- Type of anesthesia
- Implant type
Postoperative Assessments After surgery, one or more of the following will be collected through the online app and at follow-up visits.
- Device usage patterns (thru app)
- Range of motion of affected knee (thru app and at follow-up)
- TUG test
- Stair Climb test
- QFM strength
- Modified KOOS and VR-12 assessments
- VAS pain score
- Length of stay (hospital, extended care facility)
- 90 day readmission rate
- Discharge Disposition (home vs skilled nursing facility vs inpatient rehabilitation)
- Patient Satisfaction measures
- Any use of an ambulation assist aid
- Activity levels using Misfit Wearables® fitness monitor will be uploaded and incorporated into online app
As a last resort, if a patient is unable to keep one of these appointments, he/she will be either be mailed or emailed the patient reported outcome forms so the patient can fill them out. The patient will date and time the forms. Participants will then send the form back in a pre-addressed envelope. The patients email will be verified by the patient during a clinical visit to ensure accuracy of the correct recipient. Patients not responding to the initial mailer will be contacted by phone and forms may be administered over the phone. The mailers and/or phone calls will allow us to collect all data except the physical function measures.
All data will be entered and maintained in Redcap
- Conditions
- Arthropathy of Knee Joint
- Being tested
- CyMedica Orthopedics QB1 e-vive™ system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyMedica Orthopedics QB1 e-vive™ systemDevice
Also called NMES Neuromuscular electrical stimulation
a multifunctional electrotherapy device providing neuromuscular electrical stimulation (NMES), for improving quadriceps strength and improving functional outcomes accelerating functional recovery in patients managed with total knee arthroplasty (TKA).
| Study group | Role | What they receive |
|---|---|---|
| NMES preoperative and postoperative | Experimental | Subject will be given NMES CyMedica Orthopedics QB1 e-vive™ system device to use preoperative and will continue to use postoperatively until end of study Receives: Device: CyMedica Orthopedics QB1 e-vive™ system |
| NMES postoperative only | Experimental | Subject will be given NMES CyMedica Orthopedics QB1 e-vive™ system device to use postoperatively and will continue to use until end of study Receives: Device: CyMedica Orthopedics QB1 e-vive™ system |
| No intervention | No intervention | Subject will not be given device and will undergo the standard rehab protocol alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps Femoris Muscle (QFM) Strength (Dynamometer Quad Strength Lbs)
measure change in muscle strength (QFM) - difference from baseline measure to 6 weeks postoperative
Measured: 6 weeks
Secondary outcomes (8)
Knee Active Range of Motion (Extension, Flexion) in Degrees
Measure rage of motion differences between the treatment groups
Measured: 12 weeks
Visual Analogue Scale (VAS) Pain Level (0-10 Scale)
Differences in VAS scores between the treatment groups from baseline to 12 weeks postop. Higher score represents worse pain.
Measured: 12 weeks
Hospital Length of Stay (Days)
differences in length of stay between the treatment groups
Measured: 12 weeks
Number of Patients Discharged to Extended Care Facility
Patent discharge other than "home" to extended care facility
Measured: 12 weeks
Number of Patients Readmitted to Hospital
Number of all-cause readmissions to the hospital
Measured: 12 weeks
Number of Outpatient Therapy Visits (Patient Questionnaire)
Difference in number of outpatient therapy visits among the treatment groups
Measured: 12 weeks
KOOS - PS
Functional outcomes using the Knee Injury and Osteoarthritis Outcome Score (KOOS) Physical Function Shortform (PS) questionnaire. Change in total score from baseline to 12 weeks postoperative score. Minimum value is 0, maximum value is 100, and higher values mean greater improvement over baseline total score.
Measured: 12 weeks
KOOS Pain
Measure pain at 12 weeks postoperative using Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscore. Change in total score from baseline to 12 weeks postoperative score. Minimum value is 0, maximum value is 100, and higher values mean greater improvement over baseline total score.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study startJan 2017
- Primary completionJun 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Arthropathy of Knee JointStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Higuera-Rueda, The Cleveland Clinic
- Investigators
- Michael Mont, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044028
- Sponsor's protocol ID
- #16-1293
- Status last verified
- Feb 2020
- First submitted
- 20 Dec 2016
- Last updated
- 5 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Stevens-Lapsley JE, Balter JE, Wolfe P, Eckhoff DG, Kohrt WM. Early neuromuscular electrical stimulation to improve quadriceps muscle strength after total knee arthroplasty: a randomized controlled trial. Phys Ther. 2012 Feb;92(2):210-26. doi: 10.2522/ptj.20110124. Epub 2011 Nov 17.
PubMed 22095207Levine M, McElroy K, Stakich V, Cicco J. Comparing conventional physical therapy rehabilitation with neuromuscular electrical stimulation after TKA. Orthopedics. 2013 Mar;36(3):e319-24. doi: 10.3928/01477447-20130222-20.
PubMed 23464951Gotlin RS, Hershkowitz S, Juris PM, Gonzalez EG, Scott WN, Insall JN. Electrical stimulation effect on extensor lag and length of hospital stay after total knee arthroplasty. Arch Phys Med Rehabil. 1994 Sep;75(9):957-9.
PubMed 8085929Avramidis K, Karachalios T, Popotonasios K, Sacorafas D, Papathanasiades AA, Malizos KN. Does electric stimulation of the vastus medialis muscle influence rehabilitation after total knee replacement? Orthopedics. 2011 Mar 11;34(3):175. doi: 10.3928/01477447-20110124-06.
PubMed 21410130Petterson SC, Mizner RL, Stevens JE, Raisis L, Bodenstab A, Newcomb W, Snyder-Mackler L. Improved function from progressive strengthening interventions after total knee arthroplasty: a randomized clinical trial with an imbedded prospective cohort. Arthritis Rheum. 2009 Feb 15;61(2):174-83. doi: 10.1002/art.24167.
PubMed 19177542Mizner RL, Petterson SC, Stevens JE, Axe MJ, Snyder-Mackler L. Preoperative quadriceps strength predicts functional ability one year after total knee arthroplasty. J Rheumatol. 2005 Aug;32(8):1533-9.
PubMed 16078331D'Lima DD, Colwell CW Jr, Morris BA, Hardwick ME, Kozin F. The effect of preoperative exercise on total knee replacement outcomes. Clin Orthop Relat Res. 1996 May;(326):174-82. doi: 10.1097/00003086-199605000-00020.
PubMed 8620638Villadsen A. Neuromuscular exercise prior to joint arthroplasty in patients with osteoarthritis of the hip or knee. Dan Med J. 2016 Apr;63(4):B5235. No abstract available.
PubMed 27034190Rodgers JA, Garvin KL, Walker CW, Morford D, Urban J, Bedard J. Preoperative physical therapy in primary total knee arthroplasty. J Arthroplasty. 1998 Jun;13(4):414-21. doi: 10.1016/s0883-5403(98)90007-9.
PubMed 9645522Walls RJ, McHugh G, O'Gorman DJ, Moyna NM, O'Byrne JM. Effects of preoperative neuromuscular electrical stimulation on quadriceps strength and functional recovery in total knee arthroplasty. A pilot study. BMC Musculoskelet Disord. 2010 Jun 14;11:119. doi: 10.1186/1471-2474-11-119.
PubMed 20540807Klika AK, Gehrig M, Boukis L, Milidonis MK, Smith DA, Murray TG, Barsoum WK. A Rapid Recovery Program After Total Knee Arthroplasty. Semin Arthro. 2009; 20:40-44.
Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.
PubMed 9699158Brazier JE, Roberts J. The estimation of a preference-based measure of health from the SF-12. Med Care. 2004 Sep;42(9):851-9. doi: 10.1097/01.mlr.0000135827.18610.0d.
PubMed 15319610Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual analogue scales as ratio scale measures for chronic and experimental pain. Pain. 1983 Sep;17(1):45-56. doi: 10.1016/0304-3959(83)90126-4.
PubMed 6226917Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
PubMed 1991946
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Neuromuscular Electrical Stimulation (NMES) for Improving Outcomes Following Total Knee Arthroplasty (TKA)
- ClinicalTrials.gov ID
- NCT03044028
- Acronym / sponsor ID
- #16-1293
- Conditions
- Arthropathy of Knee Joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jun 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 6 Feb 2017 (estimated)
- Results
- Posted 5 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current standard for rehabilitation after TKA consists of guided exercise therapy for up to 12 weeks after surgery. This includes inpatient, home, and outpatient therapy. The surgery and rehabilitation are highly successful at reducing or eliminating pain experienced preoperatively. However, quadriceps femoris muscle (QFM) strength, overall function, and knee range of motion are often worse than preoperative levels for as long as 6 months after surgery and in some cases may persist for many years after that. Such quadriceps strength impairments after TKA have been largely attributed to voluntary activation deficits and can lead to a decrease in functional performance such as decreased gait speed, decreased balance which can lead to falls, and decreased stair climbing \& chair rise abilities.
Since therapy alone does not adequately restore or improve upon the preoperative functional capabilities in a consistent and timely manner, it has been suggested that NMES used adjunctively with postoperative rehabilitation will alleviate the quadriceps muscle activation deficits. Early NMES use after TKA has been shown to: reduce knee extensor lag, increase walking speed, and improve QFM strength, knee range of motion, and function. However, NMES initiated one month after TKA did not lead to improved QFM strength or function beyond the standard benefits gained from exercise alone, thus suggesting that the timing of NMES application after TKA is important.
It has previously been shown that preoperative QFM strength is predictive of postoperative function [6] but the benefit of prehabilitation remains in question. To date, there has only been one pilot study assessing the benefits of NMES when initiated preoperatively. This study only included 14 patients (9 NMES, 5 control) but was able to show that preoperative NMES usage may lead to greater QFM strength gains after TKA. Therefore, it will be important to assess the benefits of NMES both preoperatively and postoperatively in order to determine how it will be most beneficial to TKA patients.
Detailed description
The study duration will be until 12 weeks ± 1 week postoperatively. Data will be collected (1) 4 weeks preoperatively, (2) prior to hospital admission for TKA, and (3) at 3, 6, and 12 weeks postoperatively. The research coordinator at the site will identify, recruit, and prospectively follow the 66 patients at his/her site.
All data will be entered and maintained in REDCap, an electronic data capture tools hosted at Cleveland Clinic. REDCap (Research Electronic Data Capture) is a secure, web-based application designed to support data capture for research studies, providing 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for importing data from external sources. Only members of the study team (i.e. the personnel listed on the institutional review board (IRB) application) will have access to protected health information of patients included in this study.
Pretreatment Assessments
Before treatment, the following assessments/tests will be performed and the results will be recorded on the appropriate pages of the (case report form) CRF, and or Microsoft excel, Microsoft Word, and REDCap:
- Informed consent
- Age, gender, height/weight/(body mass index) BMI
- Concomitant diseases
- Physical examination
- Baseline range of motion of affected knee
- Baseline timed up and go test (TUG test, detailed in Appendix A and as described by Podsiadlo et al.)
- Baseline Stair Climb test
- Baseline QFM strength
- Baseline Modified Knee Injury and Osteoarthritis Outcome Score (KOOS) and Veterans Rand 12(VR-12) assessments
- Baseline VAS (visual analog scale)pain score
- Current medications
- Any use of ambulation assist device
Presurgery Assessments
Before surgery, the following assessments/tests will be performed and the results will be recorded on the appropriate pages of the CRF, and or Microsoft excel, Microsoft Word, and REDCap:
- Device usage patterns (thru app for preop NMES group)
- Range of motion of affected knee
- TUG test
- Stair Climb test
- QFM strength
- Modified KOOS and VR-12 assessments
- VAS pain score
- Current medications
- Activity levels using Misfit Wearables® fitness monitor will be uploaded and incorporated into online app
Operative Assessments
The following will be collected from the Operative and Anesthesia Records and recorded on the appropriate pages of the CRF, and or Microsoft excel, Microsoft Word, and REDCap:
- Surgeon name
- Approach used
- Randomization assignment
- Diagnosis
- Length of surgery
- Estimated blood loss
- Type of anesthesia
- Implant type
Postoperative Assessments After surgery, one or more of the following will be collected through the online app and at follow-up visits.
- Device usage patterns (thru app)
- Range of motion of affected knee (thru app and at follow-up)
- TUG test
- Stair Climb test
- QFM strength
- Modified KOOS and VR-12 assessments
- VAS pain score
- Length of stay (hospital, extended care facility)
- 90 day readmission rate
- Discharge Disposition (home vs skilled nursing facility vs inpatient rehabilitation)
- Patient Satisfaction measures
- Any use of an ambulation assist aid
- Activity levels using Misfit Wearables® fitness monitor will be uploaded and incorporated into online app
As a last resort, if a patient is unable to keep one of these appointments, he/she will be either be mailed or emailed the patient reported outcome forms so the patient can fill them out. The patient will date and time the forms. Participants will then send the form back in a pre-addressed envelope. The patients email will be verified by the patient during a clinical visit to ensure accuracy of the correct recipient. Patients not responding to the initial mailer will be contacted by phone and forms may be administered over the phone. The mailers and/or phone calls will allow us to collect all data except the physical function measures.
All data will be entered and maintained in Redcap
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NMES preoperative and postoperative | Experimental | Device: CyMedica Orthopedics QB1 e-vive™ systemSubject will be given NMES CyMedica Orthopedics QB1 e-vive™ system device to use preoperative and will continue to use postoperatively until end of study |
| NMES postoperative only | Experimental | Device: CyMedica Orthopedics QB1 e-vive™ systemSubject will be given NMES CyMedica Orthopedics QB1 e-vive™ system device to use postoperatively and will continue to use until end of study |
| No intervention | No intervention | –Subject will not be given device and will undergo the standard rehab protocol alone |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing unilateral primary total knee arthroplasty
- Patients who are between the ages of 18 - 85 years
- Patient has signed informed consent
- Patient has access to a smartphone or tablet (Android or iOS)
Key exclusion criteria (15 listed)
- BMI ≥ 40
- Inflammatory arthritis
- Patients who are expected to be in extended care facilities after surgery
- Patients who have used an at-home NMES device in the past
- Preoperative daily use of narcotics (i.e., high tolerance)
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 |
|---|---|---|
| CyMedica Orthopedics QB1 e-vive™ systemAlso: NMES Neuromuscular electrical stimulationa multifunctional electrotherapy device providing neuromuscular electrical stimulation (NMES), for improving quadriceps strength and improving functional outcomes accelerating functional recovery in patients managed with total knee arthroplasty (TKA). | Device | NMES postoperative only, NMES preoperative and postoperative |
Primary outcome
Quadriceps Femoris Muscle (QFM) Strength (Dynamometer Quad Strength Lbs)
Time frame: 6 weeks
measure change in muscle strength (QFM) - difference from baseline measure to 6 weeks postoperative
8 secondary outcomes
Knee Active Range of Motion (Extension, Flexion) in Degrees
Time frame: 12 weeks
Visual Analogue Scale (VAS) Pain Level (0-10 Scale)
Time frame: 12 weeks
Hospital Length of Stay (Days)
Time frame: 12 weeks
Number of Patients Discharged to Extended Care Facility
Time frame: 12 weeks
Number of Patients Readmitted to Hospital
Time frame: 12 weeks
Number of Outpatient Therapy Visits (Patient Questionnaire)
Time frame: 12 weeks
KOOS - PS
Time frame: 12 weeks
KOOS Pain
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22095207Stevens-Lapsley JE, Balter JE, Wolfe P, Eckhoff DG, Kohrt WM. Early neuromuscular electrical stimulation to improve quadriceps muscle strength after total knee arthroplasty: a randomized controlled trial. Phys Ther. 2012 Feb;92(2):210-26. doi: 10.2522/ptj.20110124. Epub 2011 Nov 17.
- Background: PubMed 23464951Levine M, McElroy K, Stakich V, Cicco J. Comparing conventional physical therapy rehabilitation with neuromuscular electrical stimulation after TKA. Orthopedics. 2013 Mar;36(3):e319-24. doi: 10.3928/01477447-20130222-20.
- Background: PubMed 8085929Gotlin RS, Hershkowitz S, Juris PM, Gonzalez EG, Scott WN, Insall JN. Electrical stimulation effect on extensor lag and length of hospital stay after total knee arthroplasty. Arch Phys Med Rehabil. 1994 Sep;75(9):957-9.
- Background: PubMed 21410130Avramidis K, Karachalios T, Popotonasios K, Sacorafas D, Papathanasiades AA, Malizos KN. Does electric stimulation of the vastus medialis muscle influence rehabilitation after total knee replacement? Orthopedics. 2011 Mar 11;34(3):175. doi: 10.3928/01477447-20110124-06.
- Background: PubMed 19177542Petterson SC, Mizner RL, Stevens JE, Raisis L, Bodenstab A, Newcomb W, Snyder-Mackler L. Improved function from progressive strengthening interventions after total knee arthroplasty: a randomized clinical trial with an imbedded prospective cohort. Arthritis Rheum. 2009 Feb 15;61(2):174-83. doi: 10.1002/art.24167.
- Background: PubMed 16078331Mizner RL, Petterson SC, Stevens JE, Axe MJ, Snyder-Mackler L. Preoperative quadriceps strength predicts functional ability one year after total knee arthroplasty. J Rheumatol. 2005 Aug;32(8):1533-9.
- Background: PubMed 8620638D'Lima DD, Colwell CW Jr, Morris BA, Hardwick ME, Kozin F. The effect of preoperative exercise on total knee replacement outcomes. Clin Orthop Relat Res. 1996 May;(326):174-82. doi: 10.1097/00003086-199605000-00020.
- Background: PubMed 27034190Villadsen A. Neuromuscular exercise prior to joint arthroplasty in patients with osteoarthritis of the hip or knee. Dan Med J. 2016 Apr;63(4):B5235. No abstract available.
- Background: PubMed 9645522Rodgers JA, Garvin KL, Walker CW, Morford D, Urban J, Bedard J. Preoperative physical therapy in primary total knee arthroplasty. J Arthroplasty. 1998 Jun;13(4):414-21. doi: 10.1016/s0883-5403(98)90007-9.
- Background: PubMed 20540807Walls RJ, McHugh G, O'Gorman DJ, Moyna NM, O'Byrne JM. Effects of preoperative neuromuscular electrical stimulation on quadriceps strength and functional recovery in total knee arthroplasty. A pilot study. BMC Musculoskelet Disord. 2010 Jun 14;11:119. doi: 10.1186/1471-2474-11-119.
- BackgroundKlika AK, Gehrig M, Boukis L, Milidonis MK, Smith DA, Murray TG, Barsoum WK. A Rapid Recovery Program After Total Knee Arthroplasty. Semin Arthro. 2009; 20:40-44.
- Background: PubMed 9699158Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS)--development of a self-administered outcome measure. J Orthop Sports Phys Ther. 1998 Aug;28(2):88-96. doi: 10.2519/jospt.1998.28.2.88.
- Individual participant dataSharing planned: No
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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.
Michael Mont study chair
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CyMedica Orthopedics QB1 e-vive™ system in people with Arthropathy of Knee Joint, run by The Cleveland Clinic 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 4 inclusion and 15 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 5 Mar 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?
Yes. Results are posted in the registry (first posted 5 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Quadriceps Femoris Muscle (QFM) Strength (Dynamometer Quad Strength Lbs) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03044028, which also lists 16 linked publications.
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 Mar 2020.