Clinical trial NCT04185064: 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
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Injuries
Shoulder Disease
Lead sponsor: Encore Research Inc.
Sponsor class: INDUSTRY
Collaborators: name: CoolSystems, Inc.
First posted: 2019-12-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Narcotic Consumption
timeFrame: 12 weeks
measure: European Quality of Life measure (EQ-5D)
timeFrame: 12 weeks
measure: Net Promoter Score
timeFrame: 12 weeks
measure: Number of patients with adverse events; number of adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Brantford
country: Canada
facility: Brantford General Hospital
state: Ontario
city: Cambridge
country: Canada
facility: Cambridge Memorial Hospital
state: Ontario
city: Georgetown
country: Canada
facility: Georgetown Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Hospital
state: Ontario
city: Oakville
country: Canada
facility: Oakville Trafalgar Hospital
state: Ontario
Study officials:
affiliation: St. Joseph's Healthcare; McMaster University
name: Moin Khan, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: