Total Knee ArthroplastyNCT06953375
Implementation of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty
A study testing NMES in people with Total Knee Arthroplasty and Functional Recovery, run by University of Colorado, Denver at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty, Functional Recovery, Aging
- What is being tested?
- NMES
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,250 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 May 2025to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Site Inclusion Criteria:
- UCHealth or Intermountain Health outpatient physical therapy clinic
- Patient Inclusion Criteria:
- Underwent primary unilateral TKA
- Attended outpatient rehabilitation at a participating clinic within 5 days after TKA
- Attended at least 3 total outpatient physical therapy visits in total
Who cannot join
- Patient Exclusion Criteria:
- NMES Contraindications [Patients with implanted cardiovascular cardiovertedefibrillator (ICD), active cancer, post-operative diagnosed deep vein thrombosis (DVT) in involved lower extremity]
- Previous lower extremity arthroplasty less than 12 weeks prior to scheduled TKA surgical date
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
UCHealth
Aurora, Colorado, 80045
Maggie Givan, MA, 719-251-7533, maggie.givan@cuanschutz.edu
Michael Bade, PT, PhD
- Recruiting
University of Colorado Denver, Anschutz
Aurora, Colorado, 80045
Maggie Givan, MA, 719-251-7533, maggie.givan@cuanschutz.edu
Jennifer Stevens-Lapsley, PT, PhD
- Recruiting
Intermountain Health
Murray, Utah, 84107
Matt Schneider, MBA, 801-507-8065, Matthew.Schneider@imail.org
Kate Minick, DPT, PhD
About this study
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.
Read the 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).
- Conditions
- Total Knee Arthroplasty, Functional Recovery, Aging, Physical Therapy
- Being tested
- NMES, Usual Care
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMESProcedure or surgery
The NMES intervention protocol in this study ensures patients receive NMES intervention that is adequately dosed (dose = treatment minutes x intensity), delivered using evidence-based parameters, and feasible. The investigators will deliver NMES using a portable two-channel stimulator that the investigators have found to produce stronger muscle contractions than other portable NMES units and has been used in previous clinical studies. It also has a built-in compliance meter to monitor patient treatment minutes (adherence) to NMES application. NMES sites will perform routine collection of outcomes as part of standard practice.
Usual CareOther
Usual Care clinics will continue with routine collection and documentation of physical performance outcomes as standard practice. A combination of chart reviews and on-site or remote observation will allow for characterization of usual care components for descriptive comparison. Usual Care clinics including the facility, rehabilitation clinicians, and patients will not have access to NMES materials developed for this study.
| Study group | Role | What they receive |
|---|---|---|
| NMES | Experimental | 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. Receives: Procedure: NMES |
| Usual Care | Active comparator | The Usual Care clinics will continue clinical practice as normal. Usual Care sites will not have overlap of personnel or training with NMES Sites. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG)
The TUG is a measure of mobility and balance that consists of rising from a seated position, walking three meters, and pivoting and returning to the original seated position. Faster times indicate better physical function.
Measured: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
Secondary outcomes (7)
30 Second Sit-to-Stand (30-STS)
The 30-STS is a measure of lower body strength and stamina that consists of moving from sitting to a full stand as many times as possible in 30 seconds. More completions indicate better physical function.
Measured: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
Quadriceps Strength
A commercially available hand dynamometer that uses a Bluetooth-enabled tensile load sensor will be used to assess quadriceps strength. Load sensors are reliable and valid for assessing isometric quadriceps strength. Higher scores indicate more strength
Measured: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL)
The Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL) provides a score of patients' self-reported knee stiffness, pain, and function. Scores range from 0% to 100%, with higher scores indicating fewer symptoms affecting activities of daily living.
Measured: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
Knee Range of Motion (ROM)
ROM measures the amount of movement a joint can make in a specific direction and will be assessed using a goniometer. Higher degrees of movement indicate better range of motion.
Measured: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
Visit Utilization
Visit utilization will be defined as the number of outpatient physical therapy visits attended during the patient's postoperative rehabilitation episode-of-care.
Measured: Post-operative PT baseline up to 24 weeks
Patient Satisfaction
A self-report satisfaction survey will be administered. Patient Satisfaction consists of items rated on a 5-point Likert scale. Higher scores indicate better satisfaction.
Measured: Post-operative 6 weeks
NMES Satisfaction
NMES Satisfaction is a self-report survey and consists of items rated on a 5 point Likert scale. Higher scores indicate better satisfaction.
Measured: Post-operative 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start12 May 2025
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado Health, Intermountain Health Care, Inc., National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jennifer Stevens-Lapsley, PT, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953375
- Sponsor's protocol ID
- 24-0868
- Other IDs
- R01AG084683
- Status last verified
- Sep 2025
- First submitted
- 21 Nov 2024
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study team guarantees that all data collected as part of this project will be released in accordance with standard data sharing policies and procedures to validate research findings if requested. Data will be made available in a timely manner to the broader scientific community, and will be complete, and as accurate as possible. All data released will be de-identified, with no information that could be linked to any study subjects, or participating study practices to ensure the confidentiality of all subjects and practices. If necessary, a data use agreement will be established.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Neuromuscular Electrical Stimulation After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06953375
- Acronym / sponsor ID
- 24-0868
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,250 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Colorado Health, Intermountain Health Care, Inc., National Institute on Aging (NIA)
- Study start
- 12 May 2025 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMES | Experimental | Procedure: NMESNeuromuscular 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. |
| Usual Care | Active comparator | Other: Usual CareThe Usual Care clinics will continue clinical practice as normal. Usual Care sites will not have overlap of personnel or training with NMES Sites. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- UCHealth or Intermountain Health outpatient physical therapy clinic
- Underwent primary unilateral TKA
- Attended outpatient rehabilitation at a participating clinic within 5 days after TKA
- Attended at least 3 total outpatient physical therapy visits in total
Key exclusion criteria (3 listed)
- NMES Contraindications [Patients with implanted cardiovascular cardiovertedefibrillator (ICD), active cancer, post-operative diagnosed deep vein thrombosis (DVT) in involved lower extremity]
- Previous lower extremity arthroplasty less than 12 weeks prior to scheduled TKA surgical date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMESThe NMES intervention protocol in this study ensures patients receive NMES intervention that is adequately dosed (dose = treatment minutes x intensity), delivered using evidence-based parameters, and feasible. The investigators will deliver NMES using a portable two-channel stimulator that the investigators have found to produce stronger muscle contractions than other portable NMES units and has been used in previous clinical studies. It also has a built-in compliance meter to monitor patient treatment minutes (adherence) to NMES application. NMES sites will perform routine collection of outcomes as part of standard practice. | Procedure or surgery | NMES |
| Usual CareUsual Care clinics will continue with routine collection and documentation of physical performance outcomes as standard practice. A combination of chart reviews and on-site or remote observation will allow for characterization of usual care components for descriptive comparison. Usual Care clinics including the facility, rehabilitation clinicians, and patients will not have access to NMES materials developed for this study. | Other | Usual Care |
Primary outcome
Timed Up and Go (TUG)
Time frame: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
The TUG is a measure of mobility and balance that consists of rising from a seated position, walking three meters, and pivoting and returning to the original seated position. Faster times indicate better physical function.
7 secondary outcomes
30 Second Sit-to-Stand (30-STS)
Time frame: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
Quadriceps Strength
Time frame: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL)
Time frame: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
Knee Range of Motion (ROM)
Time frame: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks
Visit Utilization
Time frame: Post-operative PT baseline up to 24 weeks
Patient Satisfaction
Time frame: Post-operative 6 weeks
NMES Satisfaction
Time frame: Post-operative 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: Yes. The study team guarantees that all data collected as part of this project will be released in accordance with standard data sharing policies and procedures to validate research findings if requested. Data will be made available in a timely manner to the broader scientific community, and will be complete, and as accurate as possible. All data released will be de-identified, with no information that could be linked to any study subjects, or participating study practices to ensure the confidentiality of all subjects and practices. If necessary, a data use agreement will be established.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Stevens-Lapsley, PT, PhD principal investigator
University of Colorado, Denver
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES in people with Total Knee Arthroplasty and Functional Recovery, run by University of Colorado, Denver at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maggie Givan, MA (719.251.7533, maggie.givan@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) (time frame: Pre-operative visit; Post-operative PT baseline, 2 weeks, 4 weeks (primary endpoint), 6 weeks, up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.