Trial Outcomes & Findings for Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery (NCT NCT02945553)
NCT ID: NCT02945553
Last Updated: 2021-01-05
Results Overview
Cross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Difference between injured and non-injured leg at 3 weeks post-surgery
Results posted on
2021-01-05
Participant Flow
Enrollment started in October 2016 and ended in December 2018. Patients were enrolled from an academic orthopedic surgical clinic.
Participant milestones
| Measure |
NMES
Neuromuscular electrical stimulation (NMES) group
Neuromuscular electrical stimulation: Neuromuscular electrical stimulation (NMES) will be performed 5 times/week for one hour each day. NMES will start within 1 week of injury and continue till 3 weeks following surgery.
|
Microstimulation
Microstimulation
Microstimulation: Microstimulation will be performed 5 times/week for one hour each day. Microstimulation will start within 1 week of injury and continue till 3 weeks following surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of Skeletal Muscle Adaptations to Traumatic Knee Injury and Surgery
Baseline characteristics by cohort
| Measure |
NMES
n=14 Participants
Neuromuscular electrical stimulation (NMES) group
Neuromuscular electrical stimulation: Neuromuscular electrical stimulation (NMES) will be performed 5 times/week for one hour each day. NMES will start within 1 week of injury and continue till 3 weeks following surgery.
|
Microstimulation
n=11 Participants
Microstimulation
Microstimulation: Microstimulation will be performed 5 times/week for one hour each day. Microstimulation will start within 1 week of injury and continue till 3 weeks following surgery.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Type of Injury
ACL rupture only
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Type of Injury
ACL rupture + Meniscus injury
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Type of Injury
ACL rupture + Meniscus injury + Cartilage injury
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Type of Injury
Exclusion found at surgery (Avulsion)
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Type of Injury
Withdrew prior to surgery
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Type of Injury
ACL rupture + Cartilage
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Difference between injured and non-injured leg at 3 weeks post-surgeryCross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types
Outcome measures
| Measure |
NMES
n=11 Participants
Neuromuscular electrical stimulation (NMES) group
Neuromuscular electrical stimulation: Neuromuscular electrical stimulation (NMES) will be performed 5 times/week for one hour each day. NMES will start within 1 week of injury and continue till 3 weeks following surgery.
|
Microstimulation
n=9 Participants
Microstimulation
Microstimulation: Microstimulation will be performed 5 times/week for one hour each day. Microstimulation will start within 1 week of injury and continue till 3 weeks following surgery.
|
|---|---|---|
|
Cross-sectional Area of Skeletal Muscle Fibers (All Fibers)
Non-injured leg
|
2827 micrometer squared
Standard Error 141
|
3318 micrometer squared
Standard Error 153
|
|
Cross-sectional Area of Skeletal Muscle Fibers (All Fibers)
Injured leg
|
2206 micrometer squared
Standard Error 125
|
2376 micrometer squared
Standard Error 130
|
PRIMARY outcome
Timeframe: Difference between injured and non-injured leg at 3 weeks post-surgeryPopulation: Difference in sample size in NMES group is due to the fact that one volunteer did not have sufficient tissue to allow assessment of muscle fiber mechanical properties.
Tension (force per unit muscle fiber cross-sectional area) from segments of chemically-skinned single human muscle fibers will be assessed under maximal calcium-activated condition, with muscle fiber type determined post-measurement by gel electrophoresis
Outcome measures
| Measure |
NMES
n=10 Participants
Neuromuscular electrical stimulation (NMES) group
Neuromuscular electrical stimulation: Neuromuscular electrical stimulation (NMES) will be performed 5 times/week for one hour each day. NMES will start within 1 week of injury and continue till 3 weeks following surgery.
|
Microstimulation
n=9 Participants
Microstimulation
Microstimulation: Microstimulation will be performed 5 times/week for one hour each day. Microstimulation will start within 1 week of injury and continue till 3 weeks following surgery.
|
|---|---|---|
|
Maximal Calcium-activated Tension Single Muscle Fiber Tension (Myosin Heavy Chain (MHC) IIA Fibers)
Injured leg
|
127 mN/mm2
Standard Error 7
|
137 mN/mm2
Standard Error 8
|
|
Maximal Calcium-activated Tension Single Muscle Fiber Tension (Myosin Heavy Chain (MHC) IIA Fibers)
Non-injured leg
|
169 mN/mm2
Standard Error 7
|
175 mN/mm2
Standard Error 7
|
PRIMARY outcome
Timeframe: Difference between injured and non-injured leg at 3 weeks post-surgeryPopulation: Difference in sample size in NMES group is due to the fact that one volunteer did not have sufficient tissue to allow assessment of muscle fiber mechanical properties.
Maximal shortening velocity from segments of chemically-skinned single human muscle fibers will be assessed, with muscle fiber type determined post-measurement by gel electrophoresis
Outcome measures
| Measure |
NMES
n=9 Participants
Neuromuscular electrical stimulation (NMES) group
Neuromuscular electrical stimulation: Neuromuscular electrical stimulation (NMES) will be performed 5 times/week for one hour each day. NMES will start within 1 week of injury and continue till 3 weeks following surgery.
|
Microstimulation
n=10 Participants
Microstimulation
Microstimulation: Microstimulation will be performed 5 times/week for one hour each day. Microstimulation will start within 1 week of injury and continue till 3 weeks following surgery.
|
|---|---|---|
|
Maximal Single Muscle Fiber Shortening Velocity (Myosin Heavy Chain (MHC) IIA Fibers)
Injured leg
|
1.74 muscle length per second (ML/s)
Standard Error 0.1
|
1.67 muscle length per second (ML/s)
Standard Error 0.09
|
|
Maximal Single Muscle Fiber Shortening Velocity (Myosin Heavy Chain (MHC) IIA Fibers)
Non-injured leg
|
1.95 muscle length per second (ML/s)
Standard Error .09
|
1.92 muscle length per second (ML/s)
Standard Error 0.09
|
PRIMARY outcome
Timeframe: Difference between injured and non-injured leg at 3 weeks post-surgeryCross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types
Outcome measures
| Measure |
NMES
n=9 Participants
Neuromuscular electrical stimulation (NMES) group
Neuromuscular electrical stimulation: Neuromuscular electrical stimulation (NMES) will be performed 5 times/week for one hour each day. NMES will start within 1 week of injury and continue till 3 weeks following surgery.
|
Microstimulation
n=11 Participants
Microstimulation
Microstimulation: Microstimulation will be performed 5 times/week for one hour each day. Microstimulation will start within 1 week of injury and continue till 3 weeks following surgery.
|
|---|---|---|
|
Cross-sectional Area of Skeletal Muscle Fibers (Myosin Heavy Chain (MHC) I Fibers)
Injured leg
|
2552 micrometer squared
Standard Error 134
|
2206 micrometer squared
Standard Error 125
|
|
Cross-sectional Area of Skeletal Muscle Fibers (Myosin Heavy Chain (MHC) I Fibers)
Non-injured leg
|
3217 micrometer squared
Standard Error 151
|
2827 micrometer squared
Standard Error 141
|
PRIMARY outcome
Timeframe: Difference between injured and non-injured leg at 3 weeks post-surgeryCross-sectional area of skeletal muscle fibers will be evaluated using immunohistochemistry, with specification of all relevant muscle fiber types
Outcome measures
| Measure |
NMES
n=9 Participants
Neuromuscular electrical stimulation (NMES) group
Neuromuscular electrical stimulation: Neuromuscular electrical stimulation (NMES) will be performed 5 times/week for one hour each day. NMES will start within 1 week of injury and continue till 3 weeks following surgery.
|
Microstimulation
n=11 Participants
Microstimulation
Microstimulation: Microstimulation will be performed 5 times/week for one hour each day. Microstimulation will start within 1 week of injury and continue till 3 weeks following surgery.
|
|---|---|---|
|
Cross-sectional Area of Skeletal Muscle Fibers (MHC IIA)
Injured leg
|
2290 micrometer squared
Standard Error 170
|
2206 micrometer squared
Standard Error 167
|
|
Cross-sectional Area of Skeletal Muscle Fibers (MHC IIA)
Non-injured leg
|
3739 micrometer squared
Standard Error 217
|
3318 micrometer squared
Standard Error 204
|
SECONDARY outcome
Timeframe: Difference between injured and non-injured leg at 6 months post-surgeryPopulation: Difference in number of volunteers in analysis is due to loss of patients during 6-month follow-up.
Peak isokinetic torque is measures in injured and non-injurd leg at 60 deg/s using dynamometry
Outcome measures
| Measure |
NMES
n=7 Participants
Neuromuscular electrical stimulation (NMES) group
Neuromuscular electrical stimulation: Neuromuscular electrical stimulation (NMES) will be performed 5 times/week for one hour each day. NMES will start within 1 week of injury and continue till 3 weeks following surgery.
|
Microstimulation
n=9 Participants
Microstimulation
Microstimulation: Microstimulation will be performed 5 times/week for one hour each day. Microstimulation will start within 1 week of injury and continue till 3 weeks following surgery.
|
|---|---|---|
|
Knee Extensor Peak Isokinetic Torque
|
59.4 % (injured to non-injured leg)
Standard Error 7.5
|
66.4 % (injured to non-injured leg)
Standard Error 6.5
|
Adverse Events
Microstimulation
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Neuromuscular Electrical Stimlulation
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Microstimulation
n=11 participants at risk
Microstimulation: Sham control group
|
Neuromuscular Electrical Stimlulation
n=14 participants at risk
Neuromuscular electrical stimulation: Treatment group
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Re-injury of ACL (graft failure)
|
9.1%
1/11 • Number of events 1 • 6 months post-surgery
Adverse event - any untoward or unfavorable medical occurrence, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants' involvement in the research, whether or not considered related to participation in the research.
|
0.00%
0/14 • 6 months post-surgery
Adverse event - any untoward or unfavorable medical occurrence, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants' involvement in the research, whether or not considered related to participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Re-injury of meniscus
|
9.1%
1/11 • Number of events 1 • 6 months post-surgery
Adverse event - any untoward or unfavorable medical occurrence, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants' involvement in the research, whether or not considered related to participation in the research.
|
0.00%
0/14 • 6 months post-surgery
Adverse event - any untoward or unfavorable medical occurrence, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants' involvement in the research, whether or not considered related to participation in the research.
|
|
Musculoskeletal and connective tissue disorders
Muscle strain
|
0.00%
0/11 • 6 months post-surgery
Adverse event - any untoward or unfavorable medical occurrence, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants' involvement in the research, whether or not considered related to participation in the research.
|
7.1%
1/14 • Number of events 1 • 6 months post-surgery
Adverse event - any untoward or unfavorable medical occurrence, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants' involvement in the research, whether or not considered related to participation in the research.
|
|
Skin and subcutaneous tissue disorders
Procedural complication.
|
0.00%
0/11 • 6 months post-surgery
Adverse event - any untoward or unfavorable medical occurrence, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants' involvement in the research, whether or not considered related to participation in the research.
|
7.1%
1/14 • Number of events 1 • 6 months post-surgery
Adverse event - any untoward or unfavorable medical occurrence, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants' involvement in the research, whether or not considered related to participation in the research.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place