Cryopneumatic Device After Shoulder Surgeries

NCT04185064 | Completed FDA Device

• 1 other identifier: GR_001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Narcotic Consumption

  12 weeks

• European Quality of Life measure (EQ-5D)

  12 weeks

• Net Promoter Score

  12 weeks

• Number of patients with adverse events; number of adverse events

  12 weeks

Study Arms (3)

Cryopnematic Device (Randomized Component)

EXPERIMENTAL

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

Standard Care

ACTIVE COMPARATOR

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

Cryopneumatic Device (Observational Cohort)

OTHER

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

Interventions

Game Ready ATX shoulder wrap; Game Ready GRPro 2.1 DEVICE

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.

Cryopnematic Device (Randomized Component); Cryopneumatic Device (Observational Cohort)

Standard Care OTHER

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.

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Encore Research Inc.: lead
• CoolSystems, Inc.: collaborator

Study Sites (5)

Brantford General Hospital

Brantford, Ontario, Canada

Location

Cambridge Memorial Hospital

Cambridge, Ontario, L8P 4W3, Canada

Location

Georgetown Hospital

Georgetown, Ontario, L8P 4W3, Canada

Location

St. Joseph's Hospital

Hamilton, Ontario, Canada

Location

Oakville Trafalgar Hospital

Oakville, Ontario, Canada

Location

Related Publications (1)

• Khan M, Phillips SA, Mathew P, Venkateswaran V, Haverstock J, Dagher D, Yardley D, Dick D, Bhandari M. Cryo-Pneumatic Compression Results in a Significant Decrease in Opioid Consumption After Shoulder Surgery: A Multicenter Randomized Controlled Trial. Am J Sports Med. 2024 Sep;52(11):2860-2865. doi: 10.1177/03635465241270138. Epub 2024 Aug 21.

  PMID: 39165152 DERIVED

MeSH Terms

Conditions

Shoulder Injuries

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Moin Khan, FRCSC

  St. Joseph's Healthcare; McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2019
• First Posted: December 4, 2019
• Study Start: September 1, 2020
• Primary Completion: May 17, 2023
• Study Completion: May 17, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)