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Clinical Trials/ISRCTN15816734
ISRCTN15816734
Completed
未知

The effect of home electrical stimulation and intra-operative femoral nerve blockage on outcomes after anterior cruciate ligament reconstruction: a prospective, randomized controlled trial with cross-over design

Empi, Inc0 sites120 target enrollmentJuly 16, 2015

Overview

Phase
未知
Intervention
Not specified
Conditions
Athletes with a torn ACL (anterior cruciate ligament)
Sponsor
Empi, Inc
Enrollment
120
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 16, 2015
End Date
September 15, 2018
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Empi, Inc

Eligibility Criteria

Inclusion Criteria

  • 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

  • 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

Outcomes

Primary Outcomes

Not specified

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