504 Participants Needed

Game Ready Cryotherapy with Compression for Postoperative Pain

JF
AB
KK
MW
Overseen ByMatthew W Bradley, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Walter Reed National Military Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a special cold and pressure device to help patients who have had shoulder, knee, or hip surgery. The device aims to reduce pain and swelling, potentially lowering the need for pain medications. Cryotherapy has been used for years to decrease swelling and pain after trauma or surgery, and it is gaining wider acceptance in sports medicine for acute and postoperative care.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What safety data exists for cryotherapy with compression for postoperative pain?

Continuous-flow cryotherapy units have been shown to decrease pain, inflammation, swelling, blood loss, and narcotic usage postoperatively. Complications are extremely rare (0.00225%) but can include frostbite, chronic pain, and loss of digits. Caution is advised for patients with risk factors for cold injury, and monitoring for signs of cold injury is recommended. Therapy should be stopped if capillary refill time exceeds 5 seconds.12345

Is the treatment Combined Cryotherapy with Compression a promising treatment for postoperative pain?

Yes, Combined Cryotherapy with Compression is a promising treatment for reducing postoperative pain. Studies show it helps manage pain after surgeries like ACL reconstruction and lumbar fusion, and it can also reduce swelling and improve recovery.12678

What data supports the idea that Game Ready Cryotherapy with Compression for Postoperative Pain is an effective treatment?

The available research shows that Game Ready Cryotherapy with Compression can be effective in reducing pain and the need for painkillers after surgeries like knee and hip replacements. For example, one study found that using this treatment after knee surgery helped reduce pain and the use of opioids, which are strong painkillers. Another study compared this treatment to just using ice after shoulder surgery and found that it was more effective in reducing pain. Additionally, after hip surgery, patients using this treatment had less blood loss and a trend towards using fewer painkillers, shorter hospital stays, and less wound discharge. Overall, these studies suggest that Game Ready Cryotherapy with Compression can help manage pain better than some other methods.1491011

Who Is on the Research Team?

AB

Ashley B Anderson, MD

Principal Investigator

Walter Reed National Military Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are scheduled for knee, shoulder, or hip arthroscopy and can understand English. They must be eligible for military health care benefits (DEERS). It's not open to those with multiple injuries or who can't consent.

Inclusion Criteria

Eligible for DEERS (Defense Enrollment Eligibility Reporting System - A system that enables uniformed service members & family members to receive health care through TRICARE)
Fluent in speaking, reading, and understanding English
You are planning to have knee, shoulder, or hip arthroscopy.

Exclusion Criteria

Unable to understand and/or provide written informed consent
Presence of concurrent additional injuries (e.g., both a knee and hip injury). Participants can only have one injury

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cryotherapy with or without compression post-operatively to manage pain and reduce inflammation

2 weeks
Daily monitoring (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple intervals

24 months
Assessments at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Combined Cryotherapy with Compression
  • Cryotherapy Alone
Trial Overview The study compares two post-surgery recovery methods: one group receives advanced cryotherapy with compression (Game Ready), while the control group gets standard cryotherapy without compression after orthopaedic surgery.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Game Ready Cryotherapy with Compression GroupExperimental Treatment1 Intervention
Post-operative treatment will involve using a Game Ready ® unit
Group II: Control Cryotherapy GroupActive Control1 Intervention
Post-operative treatment will involve using the standard of care cryotherapy (i.e., traditional ice packs without compression).

Combined Cryotherapy with Compression is already approved in European Union, United States, Canada for the following indications:

🇪🇺
Approved in European Union as Cryotherapy for:
  • Postoperative pain management
  • Swelling reduction
  • Rehabilitation after orthopaedic surgery
🇺🇸
Approved in United States as Cryotherapy for:
  • Postoperative pain management
  • Swelling reduction
  • Rehabilitation after orthopaedic surgery
🇨🇦
Approved in Canada as Cryotherapy for:
  • Postoperative pain management
  • Swelling reduction
  • Rehabilitation after orthopaedic surgery

Find a Clinic Near You

Who Is Running the Clinical Trial?

Walter Reed National Military Medical Center

Lead Sponsor

Trials
149
Recruited
33,800+

Published Research Related to This Trial

In a study of 30 patients undergoing total hip arthroplasty, the use of the Game Ready System, which combines cyclic compression and cryotherapy, significantly reduced postoperative blood loss compared to a control group using only a compression bandage.
Patients receiving cryocompression showed trends towards lower morphine usage, shorter hospital stays, and less wound discharge, suggesting potential benefits in pain management and recovery, although no significant differences in pain scores were observed.
Cryocompression therapy after elective arthroplasty of the hip.Leegwater, NC., Willems, JH., Brohet, R., et al.[2017]
In a study of 39 patients who underwent ACL reconstruction, dynamic intermittent compression combined with cryotherapy significantly reduced the need for analgesic drugs compared to static compression, with a notable decrease in tramadol and morphine usage.
Patients receiving dynamic compression also achieved better knee flexion at discharge, with an average of 90.5° compared to 84.5° for those with static compression, indicating improved postoperative recovery.
Cryotherapy with dynamic intermittent compression for analgesia after anterior cruciate ligament reconstruction. Preliminary study.Murgier, J., Cassard, X.[2022]
In a study involving 46 patients who underwent shoulder arthroscopy, there was no significant difference in postoperative pain levels or pain medication usage between those using compressive cryotherapy (CC) and those using a standard ice wrap (IW).
The results suggest that compressive cryotherapy may not provide additional benefits over standard ice treatment for managing pain after rotator cuff repair or subacromial decompression, indicating a need for further research on the cost-effectiveness of CC devices.
Compressive cryotherapy versus ice-a prospective, randomized study on postoperative pain in patients undergoing arthroscopic rotator cuff repair or subacromial decompression.Kraeutler, MJ., Reynolds, KA., Long, C., et al.[2016]

Citations

Cryocompression therapy after elective arthroplasty of the hip. [2017]
Cryotherapy with dynamic intermittent compression for analgesia after anterior cruciate ligament reconstruction. Preliminary study. [2022]
Compressive cryotherapy versus ice-a prospective, randomized study on postoperative pain in patients undergoing arthroscopic rotator cuff repair or subacromial decompression. [2016]
The role of computer-assisted cryotherapy in the postoperative treatment after total knee arthroplasty: positive effects on pain and opioid consumption. [2022]
Cryotherapy Treatment After Unicompartmental and Total Knee Arthroplasty: A Review. [2018]
Cryo-Compression Therapy After Elective Spinal Surgery for Pain Management: A Cross-Sectional Study With Historical Control. [2020]
Postoperative cryotherapy: risks versus benefits of continuous-flow cryotherapy units. [2005]
Dynamic intermittent compression cryotherapy with intravenous nefopam results in faster pain recovery than static compression cryotherapy with oral nefopam: post-anterior cruciate ligament reconstruction. [2023]
Enhanced recovery after lumbar fusion surgery: Benefits of using Game Ready©. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Orthopaedic Application of Cryotherapy: A Comprehensive Review of the History, Basic Science, Methods, and Clinical Effectiveness. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Use of Cryo/Cuff for the control of postoperative pain and edema. [2009]
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