Game Ready Cryotherapy with Compression for Postoperative Pain

Overseen By Matthew W Bradley, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Walter Reed National Military Medical Center

Disqualifiers: Concurrent injuries, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

504 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 6 7 8}

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. ^{1 4 9 10 11}

Who Is on the Research Team?

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?

Group I: Game Ready Cryotherapy with Compression Group Experimental Treatment 1 Intervention

Post-operative treatment will involve using a Game Ready ® unit

Group II: Control Cryotherapy Group Active Control 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 102 patients undergoing total knee arthroplasty, computer-assisted cryotherapy significantly reduced postoperative pain and opioid consumption during the first week compared to a control group.

While cryotherapy improved pain management, there were no significant differences in knee function or swelling between the two groups, indicating that while it helps with pain, it may not impact overall recovery metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of computer-assisted cryotherapy in the postoperative treatment after total knee arthroplasty: positive effects on pain and opioid consumption. Brouwers, HFG., de Vries, AJ., van Zuilen, M., et al.[2022]

Cryotherapy, particularly using continuous cold flow devices, is associated with better postoperative outcomes in patients undergoing knee surgeries, as evidenced by 5 out of 8 studies favoring its use over no cryotherapy.

Using cryotherapy may help reduce the need for pain medications like opioids, which can have serious side effects and risks of dependence, highlighting its potential as a safer pain management option after knee surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryotherapy Treatment After Unicompartmental and Total Knee Arthroplasty: A Review. Chughtai, M., Sodhi, N., Jawad, M., et al.[2018]

Dynamic cryo-compression (DC) therapy significantly reduced pain levels in patients after lumbar spinal surgery, with lower visual analogue scale (VAS) scores compared to a control group, indicating its efficacy in postoperative pain management.

Patients receiving DC therapy required less analgesic medication overall, suggesting that DC not only alleviates pain but may also decrease the need for additional painkillers during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryo-Compression Therapy After Elective Spinal Surgery for Pain Management: A Cross-Sectional Study With Historical Control. Nabıyev, VN., Ayhan, S., Adhıkarı, P., et al.[2020]

Continuous-flow cryotherapy units effectively reduce pain, inflammation, swelling, blood loss, and the need for narcotics after surgery, making them a beneficial postoperative treatment option.

While complications from cryotherapy are very rare (about 0.00225%), they can be serious, so it's important to monitor patients closely for signs of cold injury, especially those with known risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative cryotherapy: risks versus benefits of continuous-flow cryotherapy units. Wilke, B., Weiner, RD.[2005]

Dynamic intermittent compression cryotherapy combined with an intravenous nefopam-based pain management protocol significantly reduced postoperative pain after ACL reconstruction compared to static compression cryotherapy, with patients in the DCIVNPP group achieving acceptable pain levels sooner (Day 3) than those in the control group.

While both groups experienced similar side effects, the DCIVNPP group reported more dizziness and malaise, suggesting that the method of nefopam administration may influence side effect profiles, but overall, significant side effects diminished after Day 3.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic intermittent compression cryotherapy with intravenous nefopam results in faster pain recovery than static compression cryotherapy with oral nefopam: post-anterior cruciate ligament reconstruction. Moussa, MK., Lefevre, N., Valentin, E., et al.[2023]

The Game Ready© cryotherapy system significantly reduced postoperative pain at 24 and 48 hours after lumbar fusion surgery, leading to a 50% decrease in morphine consumption compared to the control group.

Patients using the cryotherapy system experienced less blood loss and were discharged earlier (3.9 days) than those who did not use it (5.1 days), indicating enhanced recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced recovery after lumbar fusion surgery: Benefits of using Game Ready©. De Bie, A., Siboni, R., Smati, MF., et al.[2022]

Cryotherapy, including methods like bagged ice and continuous cryotherapy devices, has been shown to reduce pain and analgesic consumption in about half of the studies reviewed, particularly after orthopedic surgeries, but its effectiveness in improving range of motion and reducing swelling is less clear.

Continuous cryotherapy devices appear to provide better outcomes in terms of pain reduction and recovery after knee arthroscopy compared to traditional ice methods, but more high-quality studies are needed to establish their superiority and safety as a standard treatment in orthopedic care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orthopaedic Application of Cryotherapy: A Comprehensive Review of the History, Basic Science, Methods, and Clinical Effectiveness. Kunkle, BF., Kothandaraman, V., Goodloe, JB., et al.[2023]

The Cryo/Cuff system, which combines cold therapy and hydrostatic pressure, was tested on 25 participants undergoing bilateral foot surgery and showed promising results in reducing postoperative pain and swelling.

Eighty percent of participants reported a decrease in pain and edema during follow-up visits, indicating that the Cryo/Cuff system is an effective tool for enhancing recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Cryo/Cuff for the control of postoperative pain and edema. Scheffler, NM., Sheitel, PL., Lipton, MN.[2009]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Cryocompression therapy after elective arthroplasty of the hip. [2017]

2. France pubmed.ncbi.nlm.nih.gov

Cryotherapy with dynamic intermittent compression for analgesia after anterior cruciate ligament reconstruction. Preliminary study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Compressive cryotherapy versus ice-a prospective, randomized study on postoperative pain in patients undergoing arthroscopic rotator cuff repair or subacromial decompression. [2016]

4. Germany pubmed.ncbi.nlm.nih.gov

The role of computer-assisted cryotherapy in the postoperative treatment after total knee arthroplasty: positive effects on pain and opioid consumption. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Cryotherapy Treatment After Unicompartmental and Total Knee Arthroplasty: A Review. [2018]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Cryo-Compression Therapy After Elective Spinal Surgery for Pain Management: A Cross-Sectional Study With Historical Control. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Postoperative cryotherapy: risks versus benefits of continuous-flow cryotherapy units. [2005]

8. Germany pubmed.ncbi.nlm.nih.gov

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]

9. France pubmed.ncbi.nlm.nih.gov

Enhanced recovery after lumbar fusion surgery: Benefits of using Game Ready©. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Orthopaedic Application of Cryotherapy: A Comprehensive Review of the History, Basic Science, Methods, and Clinical Effectiveness. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Use of Cryo/Cuff for the control of postoperative pain and edema. [2009]