N/A
N=23
Skeletal Muscle Atrophy and Dysfunction Following Total Knee Arthroplasty
Knee Osteoarthristis
Bottom Line
View on ClinicalTrials.gov: NCT03051984 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Cross-sectional Area (CSA) of Muscle Fibers — 2680; 2377; 2028; 1882 micron squared
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Neuromuscular electrical stimulation (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Vermont
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cross-sectional Area (CSA) of Muscle Fibers |
2680; 2377; 2028; 1882; 2039; 1971 | — |
| PRIMARY Intermyofibrillar Mitochondrial Content |
2.36; 2.34; 2.1; 1.7 | — |
| PRIMARY Maximal Calcium-activated Tension Single Muscle Fiber Tension |
114; 111; 112; 103; 173; 175 | — |
| SECONDARY Physical Activity Level |
4167; 4767; 2088; 2500 | — |
| SECONDARY Quadriceps Muscle Cross-sectional Area |
45.5; 38.8; 38.3; 33.8; 52.0; 46.0 | — |
| SECONDARY Short Physical Performance Battery |
9.36; 9.80; 10.45; 10.10 | — |
| SECONDARY Knee Extensor Muscle Strength |
113.0; 94.7; 65.8; 65.7; 89.9; 58.9 | — |
| SECONDARY 30-second Sit-to-stand Test |
10.45; 11.78; 10.55; 12.56 | — |
Summary
Total knee replacement, or arthroplasty, is the final clinical intervention available to relieve pain and functional limitations related to advanced stage knee osteoarthritis. Despite its beneficial effects, the early post-surgical period is characterized by the erosion of lower extremity muscle size and strength that cause further disability and slow functional recovery. While the detrimental effects of this period on muscle are widely recognized, the mechanisms underlying these adaptations are poorly understood and there are currently no widely-accepted clinical interventions to counter them
Eligibility Criteria
Inclusion Criteria
- symptomatic, primary knee osteoarthritis (OA)
- being considered for total knee arthroplasty
Exclusion Criteria
- knee OA secondary to inflammatory/autoimmune disease
- untreated/uncontrolled hypertension, diabetes or thyroid disease
- chronic heart failure, actively-treated malignancy, exercise-limiting peripheral vascular disease, stroke or neuromuscular disease
- body mass index >38 kg/m2
- lower extremity blood clot or known coagulopathies
- implanted pacemaker/ICD
Data sourced from ClinicalTrials.gov (NCT03051984). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.