NCT04185064

Cryopneumatic Device After Shoulder Surgeries

Randomized-Controlled Trial and Evaluation Cohort Study of Patients Using a Cryopneumatic Device After Open or Arthroscopic Shoulder Surgeries

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Encore Research Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study randomize patients to receive either a cryopneumatic device or standard care (ice and ice packs) following open or arthroscopic shoulder surgeries. The primary objective is to determine the impact of the cryopneumatic device on post-surgery pain management, while secondary objectives are to detemine the effect on pain, patient eperience, quality of life, narcotic consumption and time to stop narcotic usage. Patients who do not wish to participate in the randomized portion of the trial will be invited to participate in an observational cohort who will all receive the cryopneumatic device. Patients who wish to enter this cohort will not have the device provided to them for free, and will either use their insurance or pay for the device, in order to determine if patients who pay demonstrate different outcomes from the patients receiving the device for free in the RCT.

Conditions

• Shoulder Injuries
• Shoulder Disease

Interventions

Type	Name	Description
DEVICE	Game Ready ATX shoulder wrap; Game Ready GRPro 2.1	the Game Ready ATX shoulder wrap that is anatomically engineered for the shoulder joint. The wrap is connected to the Game Ready GRPro 2.1 system enabling the integrated delivery of continuous cold and intermittent pneumatic compression therapy to the shoulder joint and surrounding soft tissues.
OTHER	Standard Care	Participants will undergo post-surgical cryotherapy using the treating surgeons preferred method of cryotherapy, which can include rest, ice, and compression using standard ice packs or bag of ice, a cryocuff, or other such device.

Timeline

• Start date: 2020-09-01
• Primary completion: 2023-05-17
• Completion: 2023-05-17
• First posted: 2019-12-04
• Last updated: 2024-02-02

Locations

5 sites across 1 country: Canada

Regulatory

• FDA-regulated device study