Utility of Intermittent Cryo-Compression Versus Traditional Icing Following Arthroscopic Rotator … (NCT05095909) | Clinical Trial Compass
RecruitingNot Applicable
Utility of Intermittent Cryo-Compression Versus Traditional Icing Following Arthroscopic Rotator Cuff Repair
United States100 participantsStarted 2024-08-05
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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)
✕
What they're measuring
1
Evaluation of pain levels in the post-operative period using VAS Pain Scale.
Timeframe: up to 15 days
2
Evaluation of post-operative edema comparing pre-operative and post-operative upper arm measurements.