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Cryotherapy Following Rotator Cuff Repair Surgery

NCT04705376 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-04-22

No results posted yet for this study

Summary

The purpose of this prospective crossover study is to determine if noninferiority exists in the use of the Thermazone cryotherapy machine when compared to Breg Polarcare, the current standard-of-care cryotherapy machine, for control of pain and reduction in postoperative narcotic medication consumption following arthroscopic rotator cuff repair surgery. Specifically, the investigators propose to test the hypothesis that in adults having arthroscopic rotator cuff repairs, the Thermazone device is non-inferior to Breg Polarcare on postoperative pain and opioid use over the initial 8 postoperative days.

Conditions

  • Rotator Cuff Tears

Interventions

DEVICE

Breg Polarcare

The Breg Polarcare device is a type of cryotherapy machine that circulates ice cold water into a patch that can be worn by the patient on their affected joint (e.g., shoulder, knee).

DEVICE

Thermazone

ThermaZone is a compact device that uses thermoelectric technology to provide heating and cooling therapy without the use of ice.

Sponsors & Collaborators

  • Innovative Medical Equipment, LLC

    collaborator UNKNOWN

  • Ohio Third Frontier

    collaborator OTHER

  • University Hospitals Cleveland Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-09-01
Completion
2021-11-01
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 NCT04705376 on ClinicalTrials.gov