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

NCT05095909 | Recruiting FDA Device

• 1 other identifier: ICC2-2019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Injuries; Cryotherapy Effect

Keywords

Cryo-compression; Rotator cuff repair

Outcome Measures

Primary Outcomes (2)

• Evaluation of pain levels in the post-operative period using VAS Pain Scale.

  Evaluate effectiveness of intermittent cryo-compression therapy versus standard ice wraps for post - operative pain control through patient reported visual analog pain scores and patient - reported opioid usage in patients undergoing arthroscopic rotator cuff repair. Pain levels will be documented by the VAS Pain Scale

  up to 15 days

• Evaluation of post-operative edema comparing pre-operative and post-operative upper arm measurements.

  Evaluate effectiveness of intermittent cryo-compression therapy versus standard ice wraps for reduction of post - operative tissue swelling in patients undergoing arthroscopic rotator cuff repair by measuring circumference (inches) of upper arm using a flexible measuring tape.

  up to 15 days

Secondary Outcomes (2)

• Cost analysis of post-operative cryotherapy modalities and other historical controls of pain post-operative pain control.

  10 days

• Quality of life evaluation comparison of post-operative cryotherapy modalities using PROMIS Global-10 scale.

  1 year

Study Arms (2)

Cryo-compression

EXPERIMENTAL

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.

Device: Cryo-compression

Cryo-therapy

ACTIVE COMPARATOR

Fitted with a standard gel ice pack with wrap immediately post-operatively. Minimum 6 hours treatment per day using gel ice packs.

Other: Cryo-therapy

Interventions

Cryo-compression DEVICE

Programmable intermittent compression with integrated cryo-therapy.

Also known as: NICE Cold Therapy

Cryo-compression

Cryo-therapy OTHER

Subjects are fitted with gel ice packs and wraps.

Also known as: Gel ice pack

Cryo-therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Allina Health System: lead

Study Sites (1)

Allina Health Orthopedics

Plymouth, Minnesota, 55441, United States

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• L Pearce McCarty III, MD

  Allina Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ned Tervola, MA, LAT, ATC

CONTACT

952-946-9777; ned.tervola@allina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 27, 2021
• Study Start: August 5, 2024
• Primary Completion: June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)