Cryoablation for Rib Fractures

Overseen By Bradely W Thomas, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Flail chest, Brain injury, Spinal cord, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: During hospital admission

80 Participants Needed

Trial Summary

What is the purpose of this trial?

To determine if patients with intraoperative cryoablation have better analgesia results compared to the control group of Surgical Stabilization of Rib Fractures (SSRF) without cryoablation

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Cryoablation for Rib Fractures?

Research shows that surgical stabilization of rib fractures (SSRF) can lead to faster recovery and fewer long-term complications compared to non-surgical methods. Additionally, combining SSRF with intercostal nerve cryoneurolysis (a technique to reduce pain by freezing nerves) may improve pain control. ^{1 2 3 4 5}

Is cryoablation for rib fractures safe for humans?

The research does not provide specific safety data on cryoablation for rib fractures, but it does mention that surgical stabilization of rib fractures (SSRF) is generally associated with improved outcomes and lower complication rates compared to non-surgical methods. ^{2 3 4 5 6}

How is the treatment for rib fractures using cryoablation different from other treatments?

The treatment for rib fractures using cryoablation is unique because it combines surgical stabilization of rib fractures (SSRF) with intercostal nerve cryoablation (IC), which provides targeted and long-lasting pain relief by freezing the nerves around the ribs. This approach is different from traditional methods as it aims to improve pain control and recovery by minimizing incision length and reducing postoperative pain. ^{2 3 4 5 7}

Research Team

Bradely W. Thomas, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for adults over 18 who have been admitted with multiple displaced rib fractures and are set to undergo surgical stabilization within 72 hours of injury. It's not for those under 18 or over 79, with severe brain injuries, spinal cord injuries, certain chest conditions like flail chest, major surgeries during this admission, inability to live independently before the injury, prisoners, pregnant women or if unable to perform VATS.

Inclusion Criteria

The patient is admitted to the trauma service

I am not receiving treatment for chronic pain.

I am older than 18 years.

Exclusion Criteria

The patient is incarcerated

I have had or am expected to have emergency brain surgery during this hospital stay.

I am younger than 18 or older than 80.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Surgical Stabilization of Rib Fractures with or without cryoablation

During hospital admission

In-hospital procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including quality of life assessments and opioid use

3 months

Monthly assessments

Long-term follow-up

Participants are monitored for additional thoracic procedures and readmissions

90 days

Treatment Details

Interventions

• Cryoablation of Intercostal Nerves
• Standard surgical treatment of patients with multiple rib fractures

Trial Overview The study is testing whether using cryoablation (a technique that freezes nerves) along with standard surgery for broken ribs can provide better pain relief than surgery alone. Participants will be randomly assigned to either receive cryoablation plus surgery or just the surgery.

Participant Groups

Group I: Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy plus CRYOABLATION Experimental Treatment 1 Intervention

Adding Cryoablation of levels 3-8, in addition to patients that undergo SSRF for multiple rib fractures.

Group II: Surgical Stabilization of Rib Fractures plus Multimodal Pain Therapy Active Control 1 Intervention

Standard surgical treatment of patients with multiple rib fractures plus Multimodal Pain Therapy

Standard surgical treatment of patients with multiple rib fractures is already approved in United States, European Union for the following indications:

Approved in United States as Surgical Stabilization of Rib Fractures for:

• Flail chest
• Unstable chest wall injury
• Severe thoracic injuries

Approved in European Union as Surgical Stabilization of Rib Fractures for:

• Flail chest
• Unstable chest wall injury
• Multiple rib fractures

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Findings from Research

Surgical stabilization of rib fractures (SSRF) in severely injured patients significantly reduces mortality rates (3.3% vs. 7.6% for non-surgical treatment), based on a study of 483 patients from a multi-center database.

However, SSRF is associated with longer ventilation times and extended stays in both the intensive care unit and overall hospital, indicating a trade-off between reduced mortality and increased resource use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of surgical stabilization of rib fractures in polytrauma: an analysis of the TraumaRegister DGU®. Becker, L., Schulz-Drost, S., Spering, C., et al.[2022]

In a study of 277 trauma patients, surgical stabilization of rib fractures (SSRF) did not show overall benefits for hospital course or complications, but it significantly helped patients with lower Glasgow Coma Scale (GCS) scores, indicating severe brain injury.

Patients with reduced GCS who underwent SSRF experienced shorter ICU stays and less time on respirators, suggesting that SSRF can improve outcomes in those with both rib fractures and moderate to severe brain injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical stabilization of serial rib fractures is advantageous in patients with relevant traumatic brain injury. Freitag, P., Bechmann, C., Eden, L., et al.[2022]

In a study of 203,450 patients with multiple rib fractures, those who underwent surgical stabilization of rib fractures (SSRF) had a higher rate of home discharge (62%) compared to those managed nonoperatively (58%).

Patients treated with SSRF also experienced lower rates of lung-related readmissions at both 3 months (3.1% vs. 4.0%) and 12 months (6.2% vs. 7.6%) compared to nonoperative management, indicating better long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of surgical versus nonsurgical treatment for multiple rib fractures: A US hospital matched cohort database analysis. Shiroff, AM., Wolf, S., Wu, A., et al.[2023]

A study involving 61 Dutch healthcare professionals identified 16 barriers and 2 facilitators to the use of surgical stabilization of rib fractures (SSRF) for multiple rib fractures, highlighting a lack of knowledge and experience as significant obstacles.

The findings suggest that improving clinical knowledge and providing high-level evidence on the effectiveness and cost-effectiveness of SSRF could enhance its acceptance and implementation among healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rib Fixation for Multiple Rib Fractures: Healthcare Professionals Perceived Barriers and Facilitators to Clinical Implementation. Spronk, I., Van Wijck, SFM., Van Lieshout, EMM., et al.[2023]

In a study of 112 patients undergoing surgical stabilization of rib fractures (SSRF), those who received the intrathoracic technique required significantly less opioid medication (21.25 MME) compared to those who had the extrathoracic technique (46.20 MME) at 7-day follow-up, indicating better pain control.

The study suggests that the intrathoracic SSRF technique may be more effective for managing postoperative pain, supporting its use over the extrathoracic approach in similar surgical cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrathoracic plates versus extrathoracic plates: a comparison of postoperative pain in surgical stabilization of rib fracture technique. Tichenor, M., Reparaz, LB., Watson, C., et al.[2023]

In a study of 122 patients who underwent surgical stabilization of rib fractures (SSRF), only 4.1% developed hardware infections, indicating that while infections are uncommon, they can lead to significant complications.

An aggressive multimodal management strategy for hardware infections, including wound debridement and hardware removal, resulted in successful bony union and favorable long-term outcomes for all patients, highlighting the importance of effective treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infected hardware after surgical stabilization of rib fractures: Outcomes and management experience. Thiels, CA., Aho, JM., Naik, ND., et al.[2018]

Intercostal nerve cryoablation (IC) during surgical stabilization of rib fractures (SSRF) was found to be safe and feasible, with no significant immediate or long-term complications reported among the 20 patients who underwent the procedure.

While the study did not show a significant reduction in pain scores or opioid use for the SSRF-IC group compared to the SSRF group, further research is needed to fully evaluate the analgesic efficacy of IC for rib fractures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intercostal nerve cryoablation during surgical stabilization of rib fractures. Choi, J., Min, JG., Jopling, JK., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effect of surgical stabilization of rib fractures in polytrauma: an analysis of the TraumaRegister DGU®. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Surgical stabilization of serial rib fractures is advantageous in patients with relevant traumatic brain injury. [2022]

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

Outcomes of surgical versus nonsurgical treatment for multiple rib fractures: A US hospital matched cohort database analysis. [2023]

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

Rib Fixation for Multiple Rib Fractures: Healthcare Professionals Perceived Barriers and Facilitators to Clinical Implementation. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Intrathoracic plates versus extrathoracic plates: a comparison of postoperative pain in surgical stabilization of rib fracture technique. [2023]

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

Infected hardware after surgical stabilization of rib fractures: Outcomes and management experience. [2018]

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

Intercostal nerve cryoablation during surgical stabilization of rib fractures. [2023]