Assessing if Cryoneurolysis Improves Prehabilitation and Decreases Pain After Surgery With Less Opioid Use in TKA Patients

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

March 31, 2019

Primary Completion Date

March 31, 2021

Study Completion Date

June 30, 2021

Conditions
Arthropathy of KneePain, JointArthritis KneeOpioid Use
Interventions
DEVICE

iovera°

"Cryoneurolysis treatment using the iovera° device targeting the anterior femoral cutaneous nerve (AFCN) and the infrapatellar branch of the saphenous nerve (ISN) will occur approximately 4 weeks before surgery by a trained member of the study staff. Treatment will occur in clinic using suggested anatomical markings to target appropriate the AFCN and infrapatellar branch of the saphenous nerve (ISN) of the operative knee.~The iovera° device contains three 27- gauge needles, all 6.9mm in length which will indent the subjects' skin and be inserted under the subcutaneous fat about 7 mm. Lidocaine will be used for superficial anesthetic at the treatment site before the needles puncture the patient's skin.There are a total of 9 iovera° cooling cycles. Treatment will be performed unilaterally and will be guided by visualization and palpation of anatomical landmarks."

Sponsors
All Listed Sponsors
collaborator

Pacira Pharmaceuticals, Inc

INDUSTRY

lead

Brigham and Women's Hospital

OTHER