Achilles Tendon Rupture
Conditions
Keywords
Achilles
Brief summary
Calf muscle atrophy (muscle degeneration) is common following Achilles tendon repair due to the immobilization period necessary to ensure optimal healing. The purpose of this study is to determine if the use of neuromuscular electrical stimulation (NMES) after Achilles tendon surgery will reduce calf muscle atrophy.
Detailed description
The specific aims of this study are to evaluate the use of electrical stimulation on muscle cross-sectional area and muscle fascicle length following post-operative Achilles tendon surgery. Patients will be randomly assigned to receive an electrical stimulation unit (Compex®, DJO Global, San Diego, CA). Twenty of these units will be experimental and 20 will be sham.
Interventions
DEVICECompex® muscle stimulator
The Compex® muscle stimulator is a commercially available muscle stimulator that is approved by the Food and Drug Administration (FDA), a governmental body. It is not investigational. The investigational part of this study aims to evaluate if the use of muscle simulation after Achilles tendon surgery will reduce calf atrophy.
DEVICE(inactive) muscle stimulator
A placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.
Sponsors
DonJoy Orthotics
Orthopedic Foot and Ankle Center, Ohio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Any patient who is having surgery to treat an acute Achilles tendon rupture or any surgery that involves reflecting or repairing the distal Achilles tendon.
Exclusion criteria
1. Body mass index (BMI) greater than or equal to 45 2. Inability to consent to participate in clinical research 3. Any patient younger than 18 years old 4. Any limitations that would interfere with the delivery of electrical stimulation including, but not limited to: 1. Presence of an insulin pump 2. Pacemaker, defibrillators or other implanted electrical device 3. Neurostimulation implants 4. History of epilepsy/seizure 5. Current pregnancy. A pregnancy test will be performed for any female prior to surgical intervention per hospital protocol unless she is post-menopausal or has been sterilized. 6. Active malignancy 7. Peripheral neuropathy 8. Diabetes Mellitus 9. Ischemia of lower limbs 10. Active infection 11. Following acute trauma or fracture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduce Calf Muscle Atrophy | Pre-operative, 2 weeks, and 6 weeks post-operative | Magnetic resonance imaging (MRI) scans were conducted preoperatively and postoperatively at weeks 2 and 6 to measure cross sectional muscle volumes of the calf muscle. By measuring the muscle volume, the investigators hope to show the use of electrical stimulation will reduce calf muscle atrophy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1- Compex® Muscle Stimulator Group 1 will receive an active muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will use the stimulator for three 20 minute sessions per day.
Compex® muscle stimulator: The Compex® muscle stimulator is a commercially available muscle stimulator that is approved by the Food and Drug Administration (FDA), a governmental body. It is not investigational. The investigational part of this study aims to evaluate if the use of muscle simulation after Achilles tendon surgery will reduce calf atrophy. | 20 |
| Group 2 -(Inactive) Muscle Stimulator Group 2 will receive a placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.
(inactive) muscle stimulator: A placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Group 1- Compex® Muscle Stimulator | Group 2 -(Inactive) Muscle Stimulator | Total |
|---|---|---|---|
| Age, Continuous | 52.0 years STANDARD_DEVIATION 9.6 | 45.8 years STANDARD_DEVIATION 11.8 | 48.9 years STANDARD_DEVIATION 11.1 |
| Body Mass Index | 33.4 kg/m^2 STANDARD_DEVIATION 5.6 | 31.1 kg/m^2 STANDARD_DEVIATION 5.6 | 32.2 kg/m^2 STANDARD_DEVIATION 5.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 16 Participants | 32 Participants |
| Region of Enrollment United States | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 11 Participants | 12 Participants | 23 Participants |
| Tobacco Use Current | 2 Participants | 1 Participants | 3 Participants |
| Tobacco Use Former | 4 Participants | 2 Participants | 6 Participants |
| Tobacco Use Never | 14 Participants | 17 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 9 / 20 | 7 / 20 |
| serious Total, serious adverse events | 2 / 20 | 1 / 20 |
Outcome results
Primary
Reduce Calf Muscle Atrophy
Magnetic resonance imaging (MRI) scans were conducted preoperatively and postoperatively at weeks 2 and 6 to measure cross sectional muscle volumes of the calf muscle. By measuring the muscle volume, the investigators hope to show the use of electrical stimulation will reduce calf muscle atrophy.
Time frame: Pre-operative, 2 weeks, and 6 weeks post-operative
Population: Pre-operatively, 20 subjects were analyzed per arm. Due to subject withdrawal, 19 were available in Group 1 at 2 weeks; and only 16 were available in Group 1 at 6 weeks, and 10 were available in Group 2 at 6 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1- Compex® Muscle Stimulator | Reduce Calf Muscle Atrophy | Pre-operative Medial Gastrocnemius | 1450.4 mm^2 | Standard Deviation 392.1 |
| Group 1- Compex® Muscle Stimulator | Reduce Calf Muscle Atrophy | 2 weeks post-operative Soleus | 1835.7 mm^2 | Standard Deviation 461 |
| Group 1- Compex® Muscle Stimulator | Reduce Calf Muscle Atrophy | 2 weeks post-operative Lateral Gastrocnemius | 754.5 mm^2 | Standard Deviation 184.4 |
| Group 1- Compex® Muscle Stimulator | Reduce Calf Muscle Atrophy | 6 weeks post-operative Lateral Gastrocnemius | 729.4 mm^2 | Standard Deviation 195.6 |
| Group 1- Compex® Muscle Stimulator | Reduce Calf Muscle Atrophy | Pre-operative Soleus | 1962.2 mm^2 | Standard Deviation 456.6 |
| Group 1- Compex® Muscle Stimulator | Reduce Calf Muscle Atrophy | 6 weeks post-operative Medial Gastrocnemius | 1242.1 mm^2 | Standard Deviation 418.6 |
| Group 1- Compex® Muscle Stimulator | Reduce Calf Muscle Atrophy | 2 weeks post-operative Medial Gastrocnemius | 1348.1 mm^2 | Standard Deviation 420.7 |
| Group 1- Compex® Muscle Stimulator | Reduce Calf Muscle Atrophy | 6 weeks post-operative Soleus | 1780.3 mm^2 | Standard Deviation 471.3 |
| Group 1- Compex® Muscle Stimulator | Reduce Calf Muscle Atrophy | Pre-operative Lateral Gastrocnemius | 859.8 mm^2 | Standard Deviation 230.1 |
| Group 2 -(Inactive) Muscle Stimulator | Reduce Calf Muscle Atrophy | 6 weeks post-operative Soleus | 1907.5 mm^2 | Standard Deviation 586.4 |
| Group 2 -(Inactive) Muscle Stimulator | Reduce Calf Muscle Atrophy | Pre-operative Lateral Gastrocnemius | 874.9 mm^2 | Standard Deviation 228.4 |
| Group 2 -(Inactive) Muscle Stimulator | Reduce Calf Muscle Atrophy | Pre-operative Medial Gastrocnemius | 1634.9 mm^2 | Standard Deviation 378.2 |
| Group 2 -(Inactive) Muscle Stimulator | Reduce Calf Muscle Atrophy | Pre-operative Soleus | 2250.5 mm^2 | Standard Deviation 701.9 |
| Group 2 -(Inactive) Muscle Stimulator | Reduce Calf Muscle Atrophy | 2 weeks post-operative Lateral Gastrocnemius | 780.9 mm^2 | Standard Deviation 217.3 |
| Group 2 -(Inactive) Muscle Stimulator | Reduce Calf Muscle Atrophy | 2 weeks post-operative Medial Gastrocnemius | 1432.8 mm^2 | Standard Deviation 324 |
| Group 2 -(Inactive) Muscle Stimulator | Reduce Calf Muscle Atrophy | 2 weeks post-operative Soleus | 2057.0 mm^2 | Standard Deviation 646.7 |
| Group 2 -(Inactive) Muscle Stimulator | Reduce Calf Muscle Atrophy | 6 weeks post-operative Lateral Gastrocnemius | 722.9 mm^2 | Standard Deviation 191.6 |
| Group 2 -(Inactive) Muscle Stimulator | Reduce Calf Muscle Atrophy | 6 weeks post-operative Medial Gastrocnemius | 1316.2 mm^2 | Standard Deviation 309.7 |