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NCT03044028 · ClinicalTrials.gov registry record · NA
Neuromuscular Electrical Stimulation (NMES) for Improving Outcomes Following Total Knee Arthroplasty (TKA)
A NA study of Arthropathy of Knee Joint, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT03044028 is a NA study of Arthropathy of Knee Joint that has completed, run by The Cleveland Clinic. The registered enrollment target is 66 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03044028, a NA study of Arthropathy of Knee Joint, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study Summary
The current standard for rehabilitation after TKA consists of guided exercise therapy for up to 12 weeks after surgery. This includes inpatient, home, and outpatient therapy. The surgery and rehabilitation are highly successful at reducing or eliminating pain experienced preoperatively. However, quadriceps femoris muscle (QFM) strength, overall function, and knee range of motion are often worse than preoperative levels for as long as 6 months after surgery and in some cases may persist for many years after that. Such quadriceps strength impairments after TKA have been largely attributed to voluntary activation deficits and can lead to a decrease in functional performance such as decreased gait speed, decreased balance which can lead to falls, and decreased stair climbing \& chair rise abilities. Since therapy alone does not adequately restore or improve upon the preoperative functional capabilities in a consistent and timely manner, it has been suggested that NMES used adjunctively with postoperative rehabilitation will alleviate the quadriceps muscle activation deficits. Early NMES use after TKA has been shown to: reduce knee extensor lag, increase walking speed, and improve QFM strength, knee range of motion, and function. However, NMES initiated one month after TKA did not lead to improved QFM strength or function beyond the standard benefits gained from exercise alone, thus suggesting that the timing of NMES application after TKA is important. It has previously been shown that preoperative QFM strength is predictive of postoperative function \[6\] but the benefit of prehabilitation remains in question. To date, there has only been one pilot study assessing the benefits of NMES when initiated preoperatively. This study only included 14 patients (9 NMES, 5 control) but was able to show that preoperative NMES usage may lead to greater QFM strength gains after TKA. Therefore, it will be important to assess the benefits of NMES both preoperatively and postoperative
Conditions Studied
Interventions
- DEVICE CyMedica Orthopedics QB1 e-vive™ system
Study Locations (1)
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2017-01 |
| Est. Completion | 2018-08 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03044028
The ClinicalTrials.gov registry entry for NCT03044028 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Arthropathy of Knee Joint appearing as the primary indexed condition, and to 1 intervention - of which CyMedica Orthopedics QB1 e-vive™ system is the first listed.
NCT03044028 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT03044028 about?
NCT03044028 is a clinical study titled "Neuromuscular Electrical Stimulation (NMES) for Improving Outcomes Following Total Knee Arthroplasty (TKA)". The current standard for rehabilitation after TKA consists of guided exercise therapy for up to 12 weeks after surgery. This includes inpatient, home, and outpatient therapy. The surgery and rehabilitation are highly successful at reducing or eliminating pain experienced preoperatively. However, qua...
What is the current status of trial NCT03044028?
This trial is currently completed. It is a NA study. The enrollment target is 66 participants. The study started on 2017-01. Estimated completion is 2018-08.
What conditions does trial NCT03044028 study?
This clinical trial studies the following conditions: Arthropathy of Knee Joint.
What interventions are being tested in trial NCT03044028?
The interventions under investigation include: CyMedica Orthopedics QB1 e-vive™ system (DEVICE).
Who is sponsoring clinical trial NCT03044028?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03044028 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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