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Iovera° to Treat Pain Associated With ACL Reconstruction and Rehabilitation

NCT03688477 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-01-14

No results posted yet for this study

Summary

To evaluate the outcomes of patients undergoing iovera° treatment of the ISN and AFCN on postoperative knee pain and function following anterior cruciate ligament reconstruction

Conditions

  • Anterior Cruciate Ligament Reconstruction

Interventions

DEVICE

iovera°

iovera° is minimally-invasive procedure using cold to target sensory nerve tissue and provide temporary pain relief through cryoneurolysis. The iovera° device uses well-established principles of cryobiology to temporarily deactivate sensory nerves that contribute to pain

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-31
Primary Completion
2019-03-31
Completion
2019-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03688477 on ClinicalTrials.gov