NCT05011084

Combined Cryotherapy With Compression Versus Cryotherapy Alone After Orthopaedic Surgery

Randomized Control Trial of Combined Cryotherapy With Compression Versus Cryotherapy Alone After Orthopaedic Surgery

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 348 (actual)
• Sponsor: Walter Reed National Military Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cryotherapy has been used to enhance recovery after orthopaedic surgery. Many devices are available but few can guarantee a temperature regulation during a prolonged time and therefore have been criticized. The arrival of new advanced cryotherapy devices made it possible to test the effect of prolonged cooling on rehabilitation after arthroscopic orthopaedic procedures.

Detailed description

Opioids are most commonly administered for the treatment of pain and are among the most prescribed drugs in the United States (US). Between 2003 and 2011, opioid prescriptions increased from 149 million to 238 million \[3,5,7,11\]. In 2004, while constituting only 4.5% of the world's population, the US consumed 99% of the global supply of hydrocodone \[3,11\]. These trends resulted in the Centers for Disease Control and Prevention recognizing opioid abuse as an epidemic \[2,11\]. Pain management after orthopaedic arthroscopic procedures is mandatory regardless of the surgical technique. Cold therapy (cryotherapy) has been widely used for many years in the treatment of postoperative pain management in orthopaedic surgery and most studies have reported better pain scores and reduced drug consumptions \[1,6,8\]. Cryotherapy involves applying a cold device to the skin surrounding the injured soft tissues to reduce the intraarticular temperature. It reduces local blood flow by vasoconstriction, which in turn also reduces local inflammatory reaction, swelling, and heat experience. It also decreases the conduction of nerve signals potentially reducing pain transmission \[14,15\]. Several cryotherapy options are available: first generation cold therapy like crushed ice in a plastic bag, cold or gel packs; second-generation cold therapy with circulating ice water with or without compression; and third-generation advanced computer-assisted devices with continuous controlled cold therapy. Cryotherapy is the standard of care in some countries and rarely is used in others \[17\]. Conflicting evidence regarding the value of this treatment from randomized trials may contribute to that practice disparity \[16\]. Raynor et al \[8\] showed that cryotherapy has a statistically significant benefit in postoperative pain control, while no improvement in postoperative range of motion or drainage was found. Cryotherapy with compression units are inexpensive, easy to use, have a high level of patient satisfaction, and are rarely associated with adverse events. Raynor et al \[8\] concluded cryotherapy may be justified in the postoperative management of knee surgery. Postoperative cryotherapy with compression was proposed as a method of reducing pain and the inflammatory response in the early postoperative period after orthopaedic arthroscopic procedures. Previous study results are equivocal. Kraeutler et al \[12\] reported that there does not appear to be a significant benefit to use of cold compression over standard ice wraps in patients undergoing shoulder arthroscopy for rotator cuff repair or subacromial decompression. While Alfuth et al \[13\] concluded no recommendations can be made regarding the question whether cold compression therapy or cold therapy should be preferred immediately after arthroscopic surgery of the shoulder. Our goal is to analyze the analgesic efficacy of cryotherapy after shoulder, knee, and hip arthroscopic procedures using the Game Ready © which is a second generation cryotherapy with compression system. The investigators hypothesize this may decrease postoperative opioid usage as well as be more cost effective when compared to first generation cryotherapy (ice packs without compression) for medical healthcare systems.

Conditions

• Cryotherapy Effect
• Compression
• Postoperative Pain Management

Interventions

Type	Name	Description
DEVICE	Game Ready Cryotherapy with Compression Group	Instead of using the traditional ice-pack cryotherapy (without compression), patients randomized into this group will use the Game Ready device, which uses cryotherapy with compression, during their post-operative treatment care.
OTHER	Control Cryotherapy Group	Patients randomized to the control group will use the standard of care, which is using traditional cryotherapy (i.e., an ice pack without compression)

Timeline

• Start date: 2020-11-02
• Primary completion: 2026-07-28
• Completion: 2026-07-28
• First posted: 2021-08-18
• Last updated: 2025-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study