Cryopneumatic Device After Shoulder Surgeries

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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Injuries; Shoulder Disease
• Intervention / Treatment: Device: Game Ready ATX shoulder wrap; Game Ready GRPro 2.1; Other: Standard Care

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Steven Phillips; Phone Number: (289) 337-5717; Email: steve.phillips@myorthoevidence.com

Study Locations

• Canada
  • Ontario
    • Brantford, Ontario, Canada
      • Brantford General Hospital
    • Cambridge, Ontario, Canada, L8P 4W3
      • Cambridge Memorial Hospital
    • Georgetown, Ontario, Canada, L8P 4W3
      • Georgetown Hospital
    • Hamilton, Ontario, Canada
      • St. Joseph's Hospital
    • Oakville, Ontario, Canada
      • Oakville Trafalgar Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. men or women aged 18 years and older;
2. undergoing a unilateral primary or revision shoulder surgery (total shoulder replacement or arthroscopic surgery [rotator cuff repair, subacromial decompression, Bankart repair, Latarjet repair, debridement]).

Exclusion Criteria:

1. patients undergoing bilateral surgery;
2. patients who are pregnant or nursing;
3. patients that do not believe they can comply with the study protocol;
4. patients generally unfit for surgery;
5. patients with specific treatment preferences;
6. patients who are unable to complete questionnaires due to language barriers, decreased mental capacity, neuro-psychological problems;
7. social factors precluding follow-up; 8) inability or unwillingness to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cryopnematic Device (Randomized Component); Game Ready shoulder wrap is applied in operating room and used in recovery room for 45 mins to 1 hour. Postop Day 1 and 2: the unit will be applied by the patient or a health care provider; as cold as comfortable (34°F; adjustable to 50°F); low compression setting; 30 min on:60 min off (use the pre-set auto program); use throughout the day; use at night as needed. Postop day 3-14 and onwards: 30 min on:60 min off (use the pre-set auto program); medium compression; as cold as comfortable (34°F; adjustable to 50°F); use minimum of twice/day. This will be combined with pain management medications, range of motion, and positioning exercises.	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.
Active Comparator: Standard Care; Ice is applied in operating room and used in recovery room for 45 mins to 1 hour. Postop Day 1 and 2: the ice will be applied by the patient or a health care provider; as cold as comfortable; 30 min on:60 min off; use throughout the day; use at night as needed. Postop day 3-14 and onwards: 30 min on:60 min off; use minimum of twice/day. The patients in the control group will receive pain management strategies as would be normally dictated by the physician/therapist. This may include the use of ice, ice packs and compression bandages, as well as pain medications, range of motion, and positioning exercises	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.
Other: Cryopneumatic Device (Observational Cohort); Game Ready® shoulder wrap is applied in the operating room and used in the recovery room for 45 mins to 1 hour. Postop Day 1 and 2: the unit will be applied by the patient or a health care provider; as cold as comfortable (34°F; adjustable to 50°F); low compression setting; 30 min on:60 min off (use the pre-set auto program); use throughout the day; use at night as needed. Postop day 3-14 and onwards: 30 min on:60 min off (use the pre-set auto program); medium compression; as cold as comfortable (34°F; adjustable to 50°F); use minimum of twice/day. This will be combined with pain management medications, range of motion, and positioning exercises	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Rating Scale (NPRS)	The NPRS measures pain severity on an 11-item scale (0 to 10). The patients will be asked to choose a number from 0 to 10 that best describes their current pain. 0 would mean "no pain" and 10 would mean "worst possible pain".	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Narcotic Consumption	Narcotic usage will be measured based on the number of narcotics consumed during the study period and the time to cease narcotic use. Details of administration will be collected and recorded on the Medication Log CRF.	12 weeks
European Quality of Life measure (EQ-5D)	The European Quality of Life measure EQ-5D comprises 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) which are used to calculate a health status score from 0 (worst health) to 1 (best health). The EQ-5D also has a 0 (worst health) to 1 (best health) visual analog scale component.	12 weeks
Net Promoter Score	Patient experience will be measured using the Net Promoter Score. Patients will rate their experience on a simple 0 (worst) to 10 (best) scale. Responses are classified into 3 groups (promotors, passives, and distractors). The Net Promoter Score is the percentage of promoters minus the percentage of detractors.	12 weeks
Number of patients with adverse events; number of adverse events	All adverse events will be monitored and recorded on the Adverse Event CRF.	12 weeks

Collaborators and Investigators

• Sponsor: Encore Research Inc.
• Collaborators: CoolSystems, Inc.
• Investigators: Principal Investigator: Moin Khan, FRCSC, St. Joseph's Healthcare; McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): May 17, 2023
• Study Completion (Actual): May 17, 2023

Study Registration Dates

• First Submitted: November 30, 2019
• First Submitted That Met QC Criteria: November 30, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries
• Other Study ID Numbers: GR_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will nto be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes