Clinical trial NCT06953375: Implementation of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty
Official title: Implementation of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Total Knee Arthroplasty
Functional Recovery
Aging
Physical Therapy
Keywords: NMES (Neuromuscular Electrical Stimulation)
TKA (Total Knee Arthroplasty)
Rehabilitation
Physical Therapy
RE-AIM: Reach Effectiveness Adoption Implementation Maintenance
Implementation Science
Older Adults
Physical Function
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Colorado Health
name: Intermountain Health Care, Inc.
name: National Institute on Aging (NIA)
First posted: 2025-05-01
Enrollment: 3250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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 \[Patients with implanted cardiovascular cardiovertedefibrillator (ICD), active cancer, post-operative diagnosed deep vein thrombosis (DVT) in involved lower extremity\]

Primary outcomes:
measure: Timed Up and Go (TUG)
timeFrame: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
Secondary outcomes:
measure: 30 Second Sit-to-Stand (30-STS)
timeFrame: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
measure: Quadriceps Strength
timeFrame: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
measure: Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL)
timeFrame: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
measure: Knee Range of Motion (ROM)
timeFrame: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
measure: Visit Utilization
timeFrame: Post-operative PT baseline up to 24 weeks
measure: Patient Satisfaction
timeFrame: Post-operative 6 weeks
measure: NMES Satisfaction
timeFrame: Post-operative 6 weeks
Other outcomes:
measure: NMES Intensity
timeFrame: Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
measure: NMES Adherence
timeFrame: Post-operative week 6
measure: RE-AIM Reach
timeFrame: Throughout experimental phase (about 2.5 years)
measure: RE-AIM Adoption
timeFrame: Throughout experimental phase (about 2.5 years)
measure: RE-AIM Implementation
timeFrame: Throughout experimental phase (about 2.5 years)
measure: RE-AIM Maintenance
timeFrame: 6 months following end of experimental phase
Locations:
city: Aurora
country: United States
facility: UCHealth
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Denver, Anschutz
state: Colorado
city: Murray
country: United States
facility: Intermountain Health
state: Utah
Study officials:
affiliation: University of Colorado, Denver
name: Jennifer Stevens-Lapsley, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: