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Compares treatment options for Rotator Cuff Injuries
Official title Utility of Intermittent Cryo-Compression Versus Traditional Icing Following Arthroscopic Rotator Cuff Repair
ClinicalTrials.gov ID: NCT05095909
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join 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 likely can't join 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)
See the full eligibility 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
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Plymouth, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Plymouth, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.