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Shoulder InjuriesNCT04185064

Cryopneumatic Device After Shoulder Surgeries

A study testing Game Ready ATX shoulder wrap; Game Ready GRPro 2.1 in people with Shoulder Injuries and Shoulder Disease, run by Encore Research Inc. at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Shoulder Injuries, Shoulder Disease
What is being tested?
Game Ready ATX shoulder wrap; Game Ready GRPro 2.1
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
5 sitesCanada
Study dates
1 Sep 2020to 17 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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]).

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • Brantford General Hospital

    Brantford, Ontario

  • Cambridge Memorial Hospital

    Cambridge, Ontario, L8P 4W3

  • Georgetown Hospital

    Georgetown, Ontario, L8P 4W3

  • St. Joseph's Hospital

    Hamilton, Ontario

  • Oakville Trafalgar Hospital

    Oakville, Ontario

Other trials in Canada

About this study

Official title: 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.

Being tested
Game Ready ATX shoulder wrap; Game Ready GRPro 2.1, Standard Care
Medical subject headings
Shoulder Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

  • Standard CareOther

    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.

Study groups in NCT04185064
Study groupRoleWhat they receive
Cryopnematic Device (Randomized Component)ExperimentalGame 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.
Receives: Device: Game Ready ATX shoulder wrap; Game Ready GRPro 2.1
Standard CareActive comparatorIce 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
Receives: Other: Standard Care
Cryopneumatic Device (Observational Cohort)OtherGame 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
Receives: Device: Game Ready ATX shoulder wrap; Game Ready GRPro 2.1

What is being measured

The primary outcome is the main question the study is designed to answer.

  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".

    Measured: 12 weeks

Secondary outcomes (4)

  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

  4. Number of patients with adverse events; number of adverse events

    All adverse events will be monitored and recorded on the Adverse Event CRF.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2019
  2. Study start1 Sep 2020
  3. Primary completion17 May 2023
  4. Study completion17 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04185064
Sponsor's protocol ID
GR_001
Status last verified
Jan 2024
First submitted
30 Nov 2019
Last updated
2 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: IPD will nto be shared.

Publications

  • 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.

    PubMed 39165152

Questions about this trial

What is this clinical trial studying?

A study testing Game Ready ATX shoulder wrap; Game Ready GRPro 2.1 in people with Shoulder Injuries and Shoulder Disease, run by Encore Research Inc. at 5 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Pain Rating Scale (NPRS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04185064, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.

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