Post Operative Swelling
Conditions
Brief summary
report on post-operative effectiveness of the Geko™ device in prevention of pain and swelling after arthroscopic anterior cruciate ligament reconstruction and repairs
Detailed description
The purpose of the research is to report on post-operative effectiveness of the Geko™ device in prevention of pain and swelling after arthroscopic anterior cruciate ligament reconstruction and repairs. The primary research procedures are to report on post-operative effectiveness of the Geko™ device in prevention of pain and swelling after arthroscopic anterior cruciate ligament reconstruction and repairs, apply device after surgery, and review Patient charts with PT (physical therapy) information. The study will enroll 46 subjects; ages 13 to 65, scheduled to undergo primary unilateral anterior cruciate ligament reconstruction with either bone patella tendon bone, quadriceps tendon or Achillies allograft, subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study. a. Rather than directly stimulating the muscle, FirstKind(company who patented the Geko device) identified a suitable location for accessing the common peroneal nerve where it passes superficially near the skin. By accessing this nerve prior to its deep-superficial branch, FirstKind was able to stimulate two separate complexes of muscles, anterior and lateral muscle enjambment. Stimulating the nerve requires less current and is considerably more comfortable than directly stimulating the muscle, to achieve the same degree of muscle contractions. We have uploaded an information sheet from FirstKind with an illustration of which muscles are stimulated.
Interventions
DEVICEGeko
application of Geko device
OTHERcontrol
no Geko device applied
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
13 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* • Scheduled to undergo primary unilateral anterior cruciate ligament reconstruction with either bone patella tendon bone, quadriceps tendon or Achillies allograft. * Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study
Exclusion criteria
* • Any records flagged "break the glass" or "research opt out" * Prior ligamentous injury and/or surgery to the operative knee (arthroscopic surgeries allowed), previous ACL surgery of the target knee, previous graft failure, or relevant musculoskeletal impairment * Any pain disorder, neuro-muscular disorder, or neuropathy * History of opioid or alcohol abuse within past 3 years * Open and/or infected wound in the treatment areas or any local skin condition at the treatment sites that in the Investigator's opinion would adversely affect treatment or outcomes * History of sensitive skin * History of known to be allergic to acrylic acid * History of implanted electronic devices (for example a cardiac pacemaker) * History of recently diagnosed or suspected DVT * History of cryoglobulinemia * History of paroxysmal cold hemoglobinuria * History of cold urticaria * History of Raynaud's disease * Concomitant surgical interventions * Recent incision on lateral leg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| swelling | From enrollment to 90 days after application |
Contacts
CONTACTKarla Echeverri
Outcome results
None listed