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| Name | Class |
|---|---|
| Taos Orthopedic Institute | UNKNOWN |
| Mammoth Orthopedic Institute | UNKNOWN |
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The goal of this clinical trial is to compare effect of cold compression to standard of care in patients undergoing rotator cuff repair. The main question[s] it aims to answer are:
The primary objective of this study is to determine whether patients, who have undergone arthroscopic rotator cuff repair surgery and who use the Polar Care Wave, use fewer opioids for a shorter duration post-operatively relative to the standard of care. Therefore, all patients enrolled in the study will be prescribed opioids for pain control after surgery. These medications will be taken at the discretion of each patient but not more than the dose recommended by the physician.
The secondary objectives of this study are to determine whether patients who have undergone arthroscopic rotator cuff repair surgery and who use the Polar Care Wave:
We hypothesize that patients using the Polar Care Wave will report less frequent use and lower doses of opioid pain medications, a lower degree of pain, and improved sleep quality during the 30-day post-operative recovery period compared to patients recovering with the current standard of care (the control). We also hypothesize that these patients will have better ROM measures at 6 weeks post-operative compared to the control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cold compression | Experimental | These patients will receive a cold compression device in addition to standard postoperative care |
|
| control | No Intervention | This group will have standard postoperative care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breg Polar Care Wave Cold Compression Device | Device | cold compression sleeve |
|
| Measure | Description | Time Frame |
|---|---|---|
| postoperative opioid consumption using milligram morphine equivalents | opioid consumption conversion of opioid consumption to MMEQ | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| VAS | VAS pain scores | 6 weeks |
| sleep quality | pittsburgh sleep quality index | 6 weeks |
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Inclusion Criteria:
• Patients scheduled for arthroscopic rotator cuff surgical repair between the dates of July 17, 2023, and November 30, 2023
Exclusion Criteria:
• Patients scheduled for arthroscopic rotator cuff surgical repair outside the dates of July 17, 2023, and November 30, 2023
Adults aged 71 and above
Children below the age of 18
Other medical conditions or concomitant medication use that are known to negatively impact the outcome of rotator cuff repair
o These include diabetes, current smoker, workers compensation claim, history of prior surgery on same shoulder, chronic pain, and pre-operative opioid use. Exclusion of this population is necessary in order to limit the introduction of confounding factors that could affect opioid usage independent of the Polar Care Wave.
Concurrent participation in other studies
Prior experience using the Breg Polar Care Wave device
Do not have daily access to an internet-connected device to provide study data
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| Name | Affiliation | Role |
|---|---|---|
| Dan Guttmann, MD | Taos Orthopedic Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mammoth Hospital | Mammoth Lakes | California | 93546 | United States | ||
| Taos Orthopedic Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 8 Reeves, B. Using Cold Therapy To Improve Patient Satisfaction and Reduce Opioid Use Post Surgery, 2018. |
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only as necessary for piublication and verification of results
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The study will enroll a total of at least 60 subjects. The sample size is based on a matter of practical convenience, i.e., based on the number of arthroscopic rotator cuff repair procedures reasonably expected to be performed on eligible patients during the study's time period at the clinical sites. We carried out power analysis using our anticipated sample size of 60 subjects for a two-sided t-test with a 95% confidence interval in G*Power. For a small (0.2), medium (0.5), or large effect size (d=0.8), the achieved power would be 0.12, 0.48, or 0.86, respectively. Therefore, we anticipate good power for a large effect size and plan to carry out post hoc power analysis for insignificant results.
An equal number of subjects are required for the control group and test group (described below); thus, each group of the study will be comprised of at least 30 subjects. This will be a multi-site study. As such, all study participants will be enrolled at one of the two clinical sites.
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| Taos |
| New Mexico |
| 87571 |
| United States |
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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