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| Name | Class |
|---|---|
| BREG, Inc | INDUSTRY |
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The purpose of this study is to compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups pre-surgically, daily after surgery for 14 days, then weekly after surgery for 3 months, and at 6 months post-surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Arm | Active Comparator | Patients in this arm will receive standard therapy post-surgery and discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold therapy (bag of ice or gel pack) |
|
| Cold and Compression | Experimental | Patients in this arm will be discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold & compression therapy device provided by Sponsor) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOC (Standard of care) | Other | Patients enrolled in this arm will be discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold therapy (bag of ice or gel pack) Other Name: |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Pain NRS subscale | Compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups | Enrollment to 6 months post RCR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard Hartman, MD | Contact | (504) 412-1705 | mhart1@lsuhsc.edu | |
| Ken Bode | Contact | 504-842-1936 | ken.bode@ochsner.org |
| Name | Affiliation | Role |
|---|---|---|
| Michael Hartman, MD | Ochsner Medical Center - Kenner | Principal Investigator |
| Paul Phillips, MD | Ochsner Medical Center - Kenner | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Medical Center - Kenner | Recruiting | Kenner | Louisiana | 70065 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23118406 | Background | Su EP, Perna M, Boettner F, Mayman DJ, Gerlinger T, Barsoum W, Randolph J, Lee G. A prospective, multi-center, randomised trial to evaluate the efficacy of a cryopneumatic device on total knee arthroplasty recovery. J Bone Joint Surg Br. 2012 Nov;94(11 Suppl A):153-6. doi: 10.1302/0301-620X.94B11.30832. | |
| 27462522 | Background |
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Currently there are no plans to share the data as there are no data sharing agreements in place with other institutions.
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Cold and Compression | Device | External mechanical compression therapy (e.g., compression stockings) has been shown to reduce swelling and risk of deep vein thrombosis in the lower limbs following TKA.12,13 Combining advanced cryotherapy (continuous circulating cold flow) and dynamic compression may offer added benefits than either traditional cryotherapy (e.g., cold packs) or compression (e.g., stockings) alone. |
|
| Song M, Sun X, Tian X, Zhang X, Shi T, Sun R, Dai W. Compressive cryotherapy versus cryotherapy alone in patients undergoing knee surgery: a meta-analysis. Springerplus. 2016 Jul 13;5(1):1074. doi: 10.1186/s40064-016-2690-7. eCollection 2016. |
| 28465126 | Background | Murgier J, Cailliez J, Wargny M, Chiron P, Cavaignac E, Laffosse JM. Cryotherapy With Dynamic Intermittent Compression Improves Recovery From Revision Total Knee Arthroplasty. J Arthroplasty. 2017 Sep;32(9):2788-2791. doi: 10.1016/j.arth.2017.03.052. Epub 2017 Mar 31. |
| 38419032 | Background | Quesnot A, Mouchel S, Salah SB, Baranes I, Martinez L, Billuart F. Randomized controlled trial of compressive cryotherapy versus standard cryotherapy after total knee arthroplasty: pain, swelling, range of motion and functional recovery. BMC Musculoskelet Disord. 2024 Feb 28;25(1):182. doi: 10.1186/s12891-024-07310-7. |
| 28802778 | Background | Chughtai M, Sodhi N, Jawad M, Newman JM, Khlopas A, Bhave A, Mont MA. Cryotherapy Treatment After Unicompartmental and Total Knee Arthroplasty: A Review. J Arthroplasty. 2017 Dec;32(12):3822-3832. doi: 10.1016/j.arth.2017.07.016. Epub 2017 Jul 21. |
| 25825138 | Background | Kraeutler MJ, Reynolds KA, Long C, McCarty EC. Compressive cryotherapy versus ice-a prospective, randomized study on postoperative pain in patients undergoing arthroscopic rotator cuff repair or subacromial decompression. J Shoulder Elbow Surg. 2015 Jun;24(6):854-9. doi: 10.1016/j.jse.2015.02.004. Epub 2015 Mar 29. |
| 33512971 | Background | Kunkle BF, Kothandaraman V, Goodloe JB, Curry EJ, Friedman RJ, Li X, Eichinger JK. Orthopaedic Application of Cryotherapy: A Comprehensive Review of the History, Basic Science, Methods, and Clinical Effectiveness. JBJS Rev. 2021 Jan 26;9(1):e20.00016. doi: 10.2106/JBJS.RVW.20.00016. |
| 32876791 | Background | Kara YS, Hapa O, Isin Y, Kilic AI, Havitcioglu H. A comparison of ice wrap and subacromial injection for postoperative pain and edema control following arthroscopic rotator cuff repair. J Orthop Traumatol. 2020 Sep 2;21(1):17. doi: 10.1186/s10195-020-00556-6. |
| 27079219 | Background | Uquillas CA, Capogna BM, Rossy WH, Mahure SA, Rokito AS. Postoperative pain control after arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2016 Jul;25(7):1204-13. doi: 10.1016/j.jse.2016.01.026. Epub 2016 Apr 11. |
| 40053065 | Background | Tang H, Yang P, Wang X, Zhao B, Ling K. Assessment of the efficacy of early versus delayed mobility exercise after arthroscopic rotator cuff repair. Int Orthop. 2025 Jun;49(6):1411-1420. doi: 10.1007/s00264-025-06477-5. Epub 2025 Mar 7. |
| 35158066 | Background | Nicholson AD, Estrada JA, Mathew JI, Finocchiaro A, Pinnamaneni S, Okeke L, Dines DM, Dines JS, Taylor SA, Warren RF, Cordasco FA, Rodeo SA, Gulotta LV. Minimum 15-year follow-up for clinical outcomes of arthroscopic rotator cuff repair. J Shoulder Elbow Surg. 2022 Aug;31(8):1696-1703. doi: 10.1016/j.jse.2022.01.116. Epub 2022 Feb 11. |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |