Cryopneumatic Device After Shoulder Surgeries

Encore Research

Status: Completed

Conditions: Shoulder Injuries; Shoulder Disease

Treatments: Device: Game Ready ATX shoulder wrap; Game Ready GRPro 2.1; Other: Standard Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT04185064

GR_001

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 3 patient groups

Cryopnematic Device (Randomized Component)

Experimental group

Description:

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.

Treatment:

Device: Game Ready ATX shoulder wrap; Game Ready GRPro 2.1

Standard Care

Active Comparator group

Description:

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

Treatment:

Other: Standard Care

Cryopneumatic Device (Observational Cohort)

Other group

Description:

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

Treatment:

Device: Game Ready ATX shoulder wrap; Game Ready GRPro 2.1