Neuromuscular Electrical Stimulation (NMES) for Improving Outcomes Following Total Knee Arthroplasty (TKA)
Condition: Arthropathy of Knee Joint
MeSH terms: Joint Diseases
Study type: Interventional

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. 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
    

Intervention name(s): CyMedica Orthopedics QB1 e-vive™ system
Intervention type(s): Device
Intervention description(s): 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).
Other intervention name(s): NMES Neuromuscular electrical stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment