NCT05095909 Utility of Intermittent Cryo-Compression Versus Traditional Icing Following Arthroscopic Rotator Cuff Repair
| NCT ID | NCT05095909 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Allina Health System |
| Condition | Rotator Cuff Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-08-05 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-08-05 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
L Pearce McCarty III, MD
PRINCIPAL INVESTIGATOR
Allina Health
Frequently Asked Questions
Who can join the NCT05095909 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Rotator Cuff Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05095909 currently recruiting?
Yes, NCT05095909 is actively recruiting participants. Contact the research team at ned.tervola@allina.com for enrollment information.
Where is the NCT05095909 trial being conducted?
This trial is being conducted at Plymouth, United States.
Who is sponsoring the NCT05095909 clinical trial?
NCT05095909 is sponsored by Allina Health System. The principal investigator is L Pearce McCarty III, MD at Allina Health. The trial plans to enroll 100 participants.