Status:
WITHDRAWN
Cryotherapy Following Rotator Cuff Repair Surgery
Lead Sponsor:
University Hospitals Cleveland Medical Center
Collaborating Sponsors:
Innovative Medical Equipment, LLC
Ohio Third Frontier
Conditions:
Rotator Cuff Tears
Eligibility:
All Genders
18-89 years
Phase:
NA
Brief 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 ...
Detailed Description
Cryotherapy has traditionally been used for the acute treatment of musculoskeletal injuries and following operative procedures. Cryotherapy currently represents the standard of care following common o...
Eligibility Criteria
Inclusion
- Patients undergoing primary arthroscopic rotator cuff repair.
Exclusion
- Patients with any of the following pre-existing medical conditions: Fibromyalgia; Complex regional pain syndrome; Any pain disorder that requires the patient to take narcotic pain medication in the pre-operative time period
- Patients undergoing revision arthroscopic rotator cuff surgery
- Illiterate, non-English speaking, and pregnant individuals
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04705376
Start Date
January 1 2021
End Date
November 1 2021
Last Update
April 22 2022
Active Locations (1)
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1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106