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Utility of Intermittent Cryo-Compression Versus Traditional Icing Following Arthroscopic Rotator Cuff Repair (ICC)

Primary Purpose

Rotator Cuff Injuries, Cryotherapy Effect

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cryo-compression
Cryo-therapy
Sponsored by
Allina Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Injuries focused on measuring Cryo-compression, Rotator cuff repair

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients who are candidates for arthroscopic rotator cuff repair

    1. Acute, traumatic tear of the rotator cuff in an active patient
    2. Chronic, symptomatic tear of the rotator cuff in an active patient having failed non - operative treatment
  2. Patient agreeable to participation in the study and able to complete informed consent process and all study requirements.
  3. ≥18 years of age

Exclusion Criteria:

  1. Pregnancy (per pre-operative physical)
  2. Presence of significant glenohumeral joint osteoarthritis
  3. Age over 70
  4. History of clinically diagnosed lymphedema
  5. Morbid obesity (BMI > 45)
  6. History of drug or alcohol addiction, prior opioid dependence, or current use of opioid medication (preoperative)
  7. Investigators concern regarding subject's ability or willingness to follow protocol.
  8. History of significant vascular impairment in the affected region (e.g., from prior frostbite, diabetes, arteriosclerosis or ischemia).
  9. History of acute paroxysmal cold hemoglobinuria or cryoglobulinemia.
  10. History of Raynaud's disease or cold hypersensitivity (cold urticarial).

Sites / Locations

  • Allina Health OrthopedicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cryo-compression

Cryo-therapy

Arm Description

Fitted with compression sleeve for the NICE Recovery SystemTM applied to the operative shoulder immediately post - operatively Minimum 6 hours treatment per day post-operatively. Utilize cyro-compression unit with a "Medium" compression level (inflate to 35 mmHg for 2 minutes and then deflate to 5 mmHg for 30 seconds) and "Level 3" cooling (50F (10C)) for the first 24 hours. After that time, the compression and cooling levels will be up to the patients' discretion.

Fitted with a standard gel ice pack with wrap immediately post-operatively. Minimum 6 hours treatment per day using gel ice packs.

Outcomes

Primary Outcome Measures

Evaluation of pain levels in the post-operative period using Wong-Baker FACES Pain Scale.
Evaluate effectiveness of intermittent cryo-compression therapy versus standard ice wraps for post - operative pain control through patient reported visual analog pain scores and patient - reported opioid usage in patients undergoing arthroscopic rotator cuff repair. Pain levels will be documented by the Wong-Baker FACES Pain Scale
Evaluation of post-operative edema comparing pre-operative and post-operative upper arm measurements.
Evaluate effectiveness of intermittent cryo-compression therapy versus standard ice wraps for reduction of post - operative tissue swelling in patients undergoing arthroscopic rotator cuff repair by measuring circumference (inches) of upper arm using a flexible measuring tape.

Secondary Outcome Measures

Cost analysis of post-operative cryotherapy modalities and other historical controls of pain post-operative pain control.
Determine cost differential of intermittent compression cryotherapy versus interscalene catheter via historical controls as well as versus standard ice wraps.
Quality of life evaluation comparison of post-operative cryotherapy modalities using PROMIS Global-10 scale.
Evaluate effect of intermittent cryo-compression therapy versus standard ice wraps on patient - reported quality of life via Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10

Full Information

First Posted
October 7, 2021
Last Updated
March 14, 2023
Sponsor
Allina Health System
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1. Study Identification

Unique Protocol Identification Number
NCT05095909
Brief Title
Utility of Intermittent Cryo-Compression Versus Traditional Icing Following Arthroscopic Rotator Cuff Repair
Acronym
ICC
Official Title
Utility of Intermittent Cryo-Compression Versus Traditional Icing Following Arthroscopic Rotator Cuff Repair
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allina Health System

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

5. Study Description

Brief Summary
Effective post - operative pain control following orthopedic surgical procedures without excessive reliance upon opioid pain medication has garnered increased attention in recent years. This study will evaluate the utilization of a non-invasive, novel cryo - compression, post-operative modality to improve pain control versus standard ice wraps in the immediate post-operative phase of arthroscopic rotator cuff surgery via a randomized controlled study design. Furthermore, if this study demonstrates improved pain control, improved quality of life and decreased opioid usage with the intermittent cold compression unit, recommendations may be considered for system-wide utilization.
Detailed Description
The purpose of this study is to test the proposed increase efficacy of combining both cold and compression modalities through cryo-compression therapy in post-operative pain management in arthroscopic rotator cuff repair surgery versus a control group of standard ice wraps. As opioid use within the field of orthopedics continues to grow as an area of investigation, surgeons must look elsewhere for pain management tactics. Objectives of this study include: Evaluate effectiveness of intermittent cryo-compression therapy versus standard ice wraps for post - operative pain control through patient reported visual analog pain scores and patient - reported opioid usage in patients undergoing arthroscopic rotator cuff repair. Evaluate effectiveness of intermittent cryo-compression therapy versus standard ice wraps for reduction of post - operative tissue swelling in patients undergoing arthroscopic rotator cuff repair. Determine cost comparison of intermittent compression cryotherapy versus interscalene catheter via historical controls as well as versus standard ice wraps. Evaluate effect of intermittent cryo-compression therapy versus standard ice wraps on patient - reported quality of life via PROMIS. Patients that are candidates for arthroscopic rotator cuff repair and complete informed consent process will be enrolled in study if no exclusion criteria are present. The study has determined an enrollment goal of 100 subjects (50 intermittent cryo-compression therapy, 50 standard cryo -therapy). Following informed consent, patients enrolled in the study will be randomized in a 1:1 ratio using permuted blocks of sizes 2 and 4 to have post-operative cryotherapy using ice packs or with the intermittent cold compression therapy unit. Randomization assignments will be contained in sequentially numbered, opaque, sealed envelopes, which will be prepared by an individual not involved in patient consent or patient treatment. After the patient is consented, the next envelope in the sequence will be opened and the patient will be assigned to a group following the treatment listed in the envelope. Prior to surgery, the subject will complete pre-operative data collection. The subject will be given a tracking diary in order to record immediate post-operative data through the first post-operative visit. Subjects will undergo arthroscopic rotator cuff repair by a single surgeon as a standard of care procedure. Subjects randomized to the study group will have the compression sleeve for the NICE Recovery SystemTM applied to the operative shoulder immediately post - operatively and those randomized to the control group a standard gel ice pack with wrap. Each will use the assigned version of cold therapy with a goal of 6 hours daily and will record overages using one half hour as a minimum unit. After enrollment and surgery, subjects will follow a post-operative follow-up visit schedule including 2-days, first post-operative visit, 60 days, 3 months, 6 months, and 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injuries, Cryotherapy Effect
Keywords
Cryo-compression, Rotator cuff repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cryo-compression
Arm Type
Experimental
Arm Description
Fitted with compression sleeve for the NICE Recovery SystemTM applied to the operative shoulder immediately post - operatively Minimum 6 hours treatment per day post-operatively. Utilize cyro-compression unit with a "Medium" compression level (inflate to 35 mmHg for 2 minutes and then deflate to 5 mmHg for 30 seconds) and "Level 3" cooling (50F (10C)) for the first 24 hours. After that time, the compression and cooling levels will be up to the patients' discretion.
Arm Title
Cryo-therapy
Arm Type
Active Comparator
Arm Description
Fitted with a standard gel ice pack with wrap immediately post-operatively. Minimum 6 hours treatment per day using gel ice packs.
Intervention Type
Device
Intervention Name(s)
Cryo-compression
Other Intervention Name(s)
NICE Cold Therapy
Intervention Description
Programmable intermittent compression with integrated cryo-therapy.
Intervention Type
Other
Intervention Name(s)
Cryo-therapy
Other Intervention Name(s)
Gel ice pack
Intervention Description
Subjects are fitted with gel ice packs and wraps.
Primary Outcome Measure Information:
Title
Evaluation of pain levels in the post-operative period using Wong-Baker FACES Pain Scale.
Description
Evaluate effectiveness of intermittent cryo-compression therapy versus standard ice wraps for post - operative pain control through patient reported visual analog pain scores and patient - reported opioid usage in patients undergoing arthroscopic rotator cuff repair. Pain levels will be documented by the Wong-Baker FACES Pain Scale
Time Frame
up to 15 days
Title
Evaluation of post-operative edema comparing pre-operative and post-operative upper arm measurements.
Description
Evaluate effectiveness of intermittent cryo-compression therapy versus standard ice wraps for reduction of post - operative tissue swelling in patients undergoing arthroscopic rotator cuff repair by measuring circumference (inches) of upper arm using a flexible measuring tape.
Time Frame
up to 15 days
Secondary Outcome Measure Information:
Title
Cost analysis of post-operative cryotherapy modalities and other historical controls of pain post-operative pain control.
Description
Determine cost differential of intermittent compression cryotherapy versus interscalene catheter via historical controls as well as versus standard ice wraps.
Time Frame
10 days
Title
Quality of life evaluation comparison of post-operative cryotherapy modalities using PROMIS Global-10 scale.
Description
Evaluate effect of intermittent cryo-compression therapy versus standard ice wraps on patient - reported quality of life via Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who are candidates for arthroscopic rotator cuff repair Acute, traumatic tear of the rotator cuff in an active patient Chronic, symptomatic tear of the rotator cuff in an active patient having failed non - operative treatment Patient agreeable to participation in the study and able to complete informed consent process and all study requirements. ≥18 years of age Exclusion Criteria: Pregnancy (per pre-operative physical) Presence of significant glenohumeral joint osteoarthritis Age over 70 History of clinically diagnosed lymphedema Morbid obesity (BMI > 45) History of drug or alcohol addiction, prior opioid dependence, or current use of opioid medication (preoperative) Investigators concern regarding subject's ability or willingness to follow protocol. History of significant vascular impairment in the affected region (e.g., from prior frostbite, diabetes, arteriosclerosis or ischemia). History of acute paroxysmal cold hemoglobinuria or cryoglobulinemia. History of Raynaud's disease or cold hypersensitivity (cold urticarial).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ned Tervola, MA, LAT, ATC
Phone
952-946-9777
Email
ned.tervola@allina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
L Pearce McCarty III, MD
Organizational Affiliation
Allina Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allina Health Orthopedics
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ned K Tervola, MA, LAT, ATC
Phone
952-946-9777
Email
ned.tervola@allina.com
First Name & Middle Initial & Last Name & Degree
L Pearce McCarty III, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Utility of Intermittent Cryo-Compression Versus Traditional Icing Following Arthroscopic Rotator Cuff Repair

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