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Cryopneumatic Device After Shoulder Surgeries

Primary Purpose

Shoulder Injuries, Shoulder Disease

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Game Ready ATX shoulder wrap; Game Ready GRPro 2.1
Standard Care
Sponsored by
Encore Research Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Brantford General HospitalRecruiting
  • Cambridge Memorial HospitalRecruiting
  • Georgetown HospitalRecruiting
  • St. Joseph's HospitalRecruiting
  • Oakville Trafalgar HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Cryopnematic Device (Randomized Component)

Standard Care

Cryopneumatic Device (Observational Cohort)

Arm 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.

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

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

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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.
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.
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.
Number of patients with adverse events; number of adverse events
All adverse events will be monitored and recorded on the Adverse Event CRF.

Full Information

First Posted
November 30, 2019
Last Updated
February 2, 2021
Sponsor
Encore Research Inc.
Collaborators
CoolSystems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04185064
Brief Title
Cryopneumatic Device After Shoulder Surgeries
Official Title
Randomized-Controlled Trial and Evaluation Cohort Study of Patients Using a Cryopneumatic Device After Open or Arthroscopic Shoulder Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Encore Research Inc.
Collaborators
CoolSystems, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Injuries, Shoulder Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cryopnematic Device (Randomized Component)
Arm Type
Experimental
Arm 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.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm 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
Arm Title
Cryopneumatic Device (Observational Cohort)
Arm Type
Other
Arm 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
Intervention Type
Device
Intervention Name(s)
Game Ready ATX shoulder wrap; Game Ready GRPro 2.1
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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".
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Narcotic Consumption
Description
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.
Time Frame
12 weeks
Title
European Quality of Life measure (EQ-5D)
Description
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.
Time Frame
12 weeks
Title
Net Promoter Score
Description
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.
Time Frame
12 weeks
Title
Number of patients with adverse events; number of adverse events
Description
All adverse events will be monitored and recorded on the Adverse Event CRF.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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]). Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steven Phillips
Phone
(289) 337-5717
Email
steve.phillips@myorthoevidence.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moin Khan, FRCSC
Organizational Affiliation
St. Joseph's Healthcare; McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brantford General Hospital
City
Brantford
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Phillips
Email
steve.phillips@myorthoevidence.com
First Name & Middle Initial & Last Name & Degree
David Pugh, FRCSC
First Name & Middle Initial & Last Name & Degree
Bashar Alolabi, FRCSC
Facility Name
Cambridge Memorial Hospital
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
L8P 4W3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Phillips
Email
steve.phillips@myorthoevidence.com
First Name & Middle Initial & Last Name & Degree
Paul Mathew, FRCSC
Facility Name
Georgetown Hospital
City
Georgetown
State/Province
Ontario
ZIP/Postal Code
L8P 4W3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Phillips
Email
steve.phillips@myorthoevidence.com
First Name & Middle Initial & Last Name & Degree
Vikram Venkateswaran, FRCSC
Facility Name
St. Joseph's Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Phillips
Email
steve.phillips@myorthoevidence.com
First Name & Middle Initial & Last Name & Degree
Moin Khan, FRCSC
First Name & Middle Initial & Last Name & Degree
Jaydeep Moro, FRCSC
Facility Name
Oakville Trafalgar Hospital
City
Oakville
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Phillips
Email
steve.phillips@myorthoevidence.com
First Name & Middle Initial & Last Name & Degree
John Haverstock, FRCSC
First Name & Middle Initial & Last Name & Degree
Mark Ginty, FRCSC

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will nto be shared.

Learn more about this trial

Cryopneumatic Device After Shoulder Surgeries

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