Implementation of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty

Last updated: July 1, 2025
Sponsor: University of Colorado, Denver
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aging

Knee Replacement

Treatment

Usual Care

NMES

Clinical Study ID

NCT06953375
24-0868
R01AG084683
  • Ages > 18
  • All Genders

Study Summary

Patients experience dramatic quadriceps strength loss after total knee replacement, which contributes to persistent weakness and reduced long-term function after surgery. Neuromuscular electrical stimulation (NMES) reduces quadriceps weakness and improves patient function after knee replacement, but it is drastically underused in rehabilitation practice. This randomized trial will examine the effectiveness and feasibility of a comprehensive strategy for implementing neuromuscular electrical stimulation after knee replacement in two large healthcare organizations.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Site Inclusion Criteria:

• UCHealth or Intermountain Health outpatient physical therapy clinic

Patient Inclusion Criteria:

  • Underwent primary unilateral TKA

  • Used NMES unit within 7 days after TKA and attended outpatient rehabilitation at aparticipating clinic within 14 days after TKA

  • Attended at least 3 total outpatient physical therapy visits in total

Exclusion

Exclusion Criteria:

Patient Exclusion Criteria:

  • NMES Contraindications [Patients with implanted cardiovascularcardiovertedefibrillator (ICD), active cancer, post-operative diagnosed deep veinthrombosis (DVT) in involved lower extremity]

  • Previous lower extremity arthroplasty less than 12 weeks prior to scheduled TKAsurgical date

Study Design

Total Participants: 3250
Treatment Group(s): 2
Primary Treatment: Usual Care
Phase:
Study Start date:
May 12, 2025
Estimated Completion Date:
April 30, 2029

Study Description

Total Knee Arthroplasty (TKA) reduces pain and disability caused by knee osteoarthritis, but the surgery results in substantial trauma to the knee. This acute trauma exacerbates underlying weakness-especially in the quadriceps. This leads to muscle atrophy and likely contributes to the long-term weakness and disability patients with TKA experience relative to their healthy peers. Attenuating quadriceps strength loss should be a primary target for improving rehabilitation outcomes after TKA.

Neuromuscular electrical stimulation (NMES) is recommended in TKA clinical practice guidelines to attenuate quadriceps strength loss. In controlled settings, NMES has established efficacy and attenuates quadriceps strength loss by 40% in the first month after surgery by overriding muscle activation deficits and reducing muscle atrophy. However, the effectiveness of NMES after TKA has not been adequately studied in real-world clinical settings, and preliminary data suggests that less than 4% of rehabilitation clinicians are using NMES as recommended by current TKA practice guidelines.

To address this gap, the investigators will conduct a cluster randomized trial in two healthcare systems (UCHealth and Intermountain Health) and their associated outpatient physical therapy clinics (n=30) to evaluate the effectiveness and implementation of NMES to address musculoskeletal deficits after TKA.

The investigators will compare outcomes between patients who receive contemporary rehabilitation supported by a comprehensive NMES implementation strategy (NMES) to patients who receive contemporary musculoskeletal rehabilitation alone (Usual Care; Aim 1). The investigators will gather information on NMES implementation to promote its uptake and translation to clinical practice (Aim 2).

Connect with a study center

  • UCHealth

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • University of Colorado Denver, Anschutz

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • Intermountain Health

    Murray, Utah 84107
    United States

    Active - Recruiting

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