ClinicalTrials.Veeva

Menu

Implementation of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Enrolling

Conditions

Aging
Functional Recovery
Total Knee Arthroplasty
Physical Therapy

Treatments

Procedure: NMES
Other: Usual Care

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06953375
24-0868
R01AG084683 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment

3,250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 a participating clinic within 14 days after TKA
  • Attended at least 3 total outpatient physical therapy visits in total

Exclusion criteria

Patient Exclusion Criteria:

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

3,250 participants in 2 patient groups

NMES
Experimental group
Description:
Neuromuscular Electrical Stimulation (NMES) consists of usual care rehabilitation plus evidence-based implementation of NMES in the early postoperative period to improve physical function after TKA.
Treatment:
Procedure: NMES
Usual Care
Active Comparator group
Description:
The Usual Care clinics will continue clinical practice as normal. Usual Care sites will not have overlap of personnel or training with NMES Sites.
Treatment:
Other: Usual Care

Trial contacts and locations

3

Loading...

Central trial contact

Maggie Givan, MA

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems