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

NCT03836313 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-07-10

No results posted yet for this study

Summary

This is a prospective, randomized control trial to evaluate the impacts of preoperative cryoneurolysis treatment on opioid consumption with prehabilitation and resulting postoperative functional improvement in patients undergoing elective primary total knee arthroplasty (TKA).

Conditions

  • Arthropathy of Knee
  • Pain, Joint
  • Arthritis Knee
  • Opioid 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 & Collaborators

  • Pacira Pharmaceuticals, Inc

    collaborator INDUSTRY

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Antonia Chen, MD/MBA · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-31
Primary Completion
2021-03-31
Completion
2021-06-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03836313 on ClinicalTrials.gov