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

Recruiting now · Not applicable

Conditions studied: Rotator Cuff Injuries, Cryotherapy Effect

In brief

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.

Key facts

Study ID

NCT05095909

Run by

Allina Health System

People needed

100

Starts

2024-08-05

Expected to finish

2026-12-01

Last updated by the study team

2026-01-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Allina Health Orthopedics — Plymouth, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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