Early Postoperative Compex Rehab NMES Use for Total Knee Arthroplasty Patients

NCT01844193 | Completed Results

• 1 other identifier: DJO-NMES-12
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the effects, if any, of using muscle stimulation on the quadriceps following a total knee replacement. Secondary objectives will be to evaluate and compare pain levels, qualitative outcomes, and the impact of NMES on pain medication requests between groups. It is possible that strengthening the quadriceps muscles and improving their activation will reduce postoperative pain and help patients return to activities sooner than with standard therapy alone.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in Quadriceps Force

  Change in quadriceps force is the difference between average quadriceps force measurements (in Newtons) obtained at the 1-year postoperative follow-up minus the average quadriceps force measurement at baseline. Averages are stratified by study arm. Negative values indicate a reduction in quadriceps force from baseline measurement to 1-year.

  Baseline and 1-year Follow-up

Secondary Outcomes (1)

• Change in VAS Pain Scores

  Baseline and 1-year Follow-up

Study Arms (2)

Standard Therapy

NO INTERVENTION

This arm of the study will follow the standard therapy course after total knee arthroplasty.

Standard Therapy + NMES

EXPERIMENTAL

This arm will follow the standard course of therapy but also incorporate daily neuromuscular electrical stimulation into the daily therapy regimen after total knee arthroplasty through use of the Compex Rehab device.

Device: Compex Rehab

Interventions

Compex Rehab DEVICE

Participants in this arm will use a Compex® Rehab unit for neuromuscular electrical stimulation starting with postoperative at-home day 1 and continue using the unit twice a day, every day, until a 10-week follow-up is reached. The unit produces a 380 microsecond biphasic curve and utilizes a four phase process for the treatment ("Warm-up", "Work", "Relaxation", and "Recovery") for a total treatment time of 20 minutes and 5 seconds per session. All frequencies are delivered at the maximum subjective tolerable intensity. Participants will control this intensity and be asked to select a level that is tolerable although mildly uncomfortable; they will be instructed to increase this intensity as tolerated.

Standard Therapy + NMES

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is a candidate for unilateral primary total knee arthroplasty and has a primary diagnosis of osteoarthritis.
• Patient is a male or non-pregnant female age 18 and older at time of surgery.
• Patient has signed an Institutional review board (IRB)-approved, study-specific informed consent form.
• Patient is willing and able to comply with the postoperative scheduled clinical evaluations and rehabilitation.

You may not qualify if:

• Patient has active infection within the affected knee joint.
• Patient requires revision surgery of a previously implanted total knee arthroplasty.
• Patient is morbidly obese, defined as having a body mass index (BMI) greater than or equal to 36.
• Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the intervention.
• Patient has been diagnosed with a systemic disease or current life threatening illness and is not able to carry on normal activities of daily life (e.g. Paget's disease, renal osteodystrophy, etc.).
• Patient has a history of cardiac issues including myocardial infarction and/or has a pacemaker.
• Patient is immunologically suppressed or receiving chronic steroids in excess of 5mg per day.
• Patient has a recent history of substance dependency that may result in deviations from the evaluation schedule.
• Patient is a prisoner.
• Patient has indication for contralateral total knee arthroplasty within the evaluation window.

Sponsors & Collaborators

• Orthopaedic Research Foundation: lead
• DJO Incorporated: collaborator

Study Sites (1)

OrthoIndy

Greenwood, Indiana, 46143, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Dr. Frank Kolisek
• Organization: OrthoIndy

fkolisek@orthoindy.com

3178845160

Study Officials

• Frank R Kolisek, MD

  OrthoIndy South

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2013
• First Posted: May 1, 2013
• Study Start: January 1, 2013
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: April 12, 2021
• Results First Posted: April 12, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)