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

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• 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

Locations
United States
Minnesota
Allina Health Orthopedics
RECRUITING
Plymouth
Contact Information
Primary
Ned Tervola, MA, LAT, ATC
ned.tervola@allina.com
952-946-9777
Time Frame
Start Date: 2024-08-05
Estimated Completion Date: 2026-12
Participants
Target number of participants: 100
Treatments
Experimental: Cryo-compression
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.
Active_comparator: Cryo-therapy
Fitted with a standard gel ice pack with wrap immediately post-operatively. Minimum 6 hours treatment per day using gel ice packs.
Authors
L. Pearce McCarty III
Related Therapeutic Areas
Sponsors
Leads: Allina Health System

This content was sourced from clinicaltrials.gov

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