The effect of home electrical stimulation and intra-operative femoral nerve blockage on outcomes after anterior cruciate ligament reconstructio
- Conditions
- Athletes with a torn ACL (anterior cruciate ligament)Injury, Occupational Diseases, Poisoning
- Registration Number
- ISRCTN15816734
- Lead Sponsor
- Empi, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
Inclusion criteria for athletes with ACL reconstruction:
1. 14-49 years old
2. Prior to injury, athletes participated in level I/II cutting, pivoting, jumping, and lateral movement sports at least 50 hours/year
3. Acute unilateral ACL tear with plan for reconstruction with hamstring autograft
4. All eligible patients must provide written informed consent (assent for children ages 14-17) prior to participation
Exclusion criteria for athletes with ACL reconstruction:
1. Prior ACLR (either ipsilateral or contralateral)
2. Patients who have a medical history that includes serious lower extremity injury or surgery (i.e., anterior cruciate ligament reconstruction, fractures) that may affect performance of dynamic jumping tasks
3. Patients who have a medical history of heart disease, ischemia of the lower limbs, arterial/circulation problems, rheumatic disease, epilepsy, any infectious disease, or anyone who has a pacemaker, defibrillator, or any other kind of electrical or metal implants
4. Patients who medically necessitate immediate (less than 2 weeks) surgical intervention to address secondary injury as determined by MD
5. Women who are currently pregnant
6. Patients who will not be in the Columbus area for 2 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Disease-specific questionnaires, including the International Knee Documentation Committee (IKDC), Knee Osteoarthritis Outcome Score (KOOS), the Marx Activity Scale, and the SF-36 Health Survey<br> 2. Magnetic resonance imaging (MRI) - in addition to the six weeks post-operative clinical assessment, the subjects will undergo a post-operative MRI of the knee and thigh regions, bilaterally. The purpose of the MRI is to assess the cross-sectional area of the quadriceps musculature post-operatively compared to the contralateral limb to report on the change in the muscle size during the course of the intervention.<br>
- Secondary Outcome Measures
Name Time Method