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NCT04185064

Cryopneumatic Device After Shoulder Surgeries

Completed NA Last updated 2 February 2024
What this trial tests

NA trial testing Game Ready ATX shoulder wrap; Game Ready GRPro 2.1 in Shoulder Injuries in 200 participants. Completed in 17 May 2023.

Timeline
1 September 2020
Primary endpoint
17 May 2023
17 May 2023

Quick facts

Lead sponsorEncore Research Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment200
Start date1 September 2020
Primary completion17 May 2023
Estimated completion17 May 2023
Sites5 locations across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Encore Research Inc.

Who can join

18 and older, any sex, with Shoulder Injuries or Shoulder Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Cryo-Pneumatic Compression Results in a Significant Decrease in Opioid Consumption After Shoulder Surgery: A Multicenter Randomized Controlled Trial.
    Khan M, Phillips SA, Mathew P, Venkateswaran V, et al · · 2024 · cited 3× · PMID 39165152 · DOI 10.1177/03635465241270138

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Other recruiting trials for Shoulder Injuries

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04185064.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing