Cryopneumatic Device After Shoulder Surgeries

Shoulder Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04185064
• Other study ID #: GR_001
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: May 17, 2023

Study information

• Verified date: January 2024
• Source: Encore Research Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 17, 2023
• Est. primary completion date: May 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Disease
• Shoulder Injuries

Intervention

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.

Locations

Country	Name	City	State
Canada	Brantford General Hospital	Brantford	Ontario
Canada	Cambridge Memorial Hospital	Cambridge	Ontario
Canada	Georgetown Hospital	Georgetown	Ontario
Canada	St. Joseph's Hospital	Hamilton	Ontario
Canada	Oakville Trafalgar Hospital	Oakville	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Encore Research Inc.	CoolSystems, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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