RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05095909

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients who are candidates for arthroscopic rotator cuff repair
  2. 1. Acute, traumatic tear of the rotator cuff in an active patient
  3. 2. Chronic, symptomatic tear of the rotator cuff in an active patient having failed non - operative treatment
  4. 2. Patient agreeable to participation in the study and able to complete informed consent process and all study requirements.
  5. 3. ≥18 years of age
  1. 1. Pregnancy (per pre-operative physical)
  2. 2. Presence of significant glenohumeral joint osteoarthritis
  3. 3. Age over 70
  4. 4. History of clinically diagnosed lymphedema
  5. 5. Morbid obesity (BMI \> 45)
  6. 6. History of drug or alcohol addiction, prior opioid dependence, or current use of opioid medication (preoperative)
  7. 7. Investigators concern regarding subject's ability or willingness to follow protocol.
  8. 8. History of significant vascular impairment in the affected region (e.g., from prior frostbite, diabetes, arteriosclerosis or ischemia).
  9. 9. History of acute paroxysmal cold hemoglobinuria or cryoglobulinemia.
  10. 10. History of Raynaud's disease or cold hypersensitivity (cold urticarial).

Contacts and Locations

Study Contact

Ned Tervola, MA, LAT, ATC
CONTACT
952-946-9777
ned.tervola@allina.com

Principal Investigator

L Pearce McCarty III, MD
PRINCIPAL_INVESTIGATOR
Allina Health

Study Locations (Sites)

Allina Health Orthopedics
Plymouth, Minnesota, 55441
United States

Collaborators and Investigators

Sponsor: Allina Health System

  • L Pearce McCarty III, MD, PRINCIPAL_INVESTIGATOR, Allina Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03
Study Completion Date2025-06

Study Record Updates

Study Start Date2023-03
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • Cryo-compression
  • Rotator cuff repair

Additional Relevant MeSH Terms

  • Rotator Cuff Injuries
  • Cryotherapy Effect