Prophylactic Foraminotomy for C5 Palsy
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a potential solution to prevent C5 palsy, a rare but serious complication that can occur after certain neck surgeries. C5 palsy often causes weakness in the shoulder and upper arm muscles, along with possible pain and sensory issues, significantly affecting quality of life. The study will test whether adding a procedure called "foraminotomy" during cervical decompression surgery (a type of neck surgery) can reduce the risk of this complication. Participants suitable for this trial are those scheduled for neck surgeries like laminoplasty or laminectomy at specific medical centers, without existing shoulder muscle weakness or prior neck surgeries. As an unphased trial, this study offers participants the chance to contribute to important research that could improve surgical outcomes for future patients.
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 prior data suggests that this technique is safe for cervical decompression surgery?
Research has shown that a surgical technique called prophylactic bilateral foraminotomy, used during neck spine surgery, might help prevent C5 palsy. C5 palsy can lead to weakness in the shoulder and upper arm muscles and sometimes causes sensory issues or pain.
One study of patients who underwent similar surgeries found that about 9.9% required another operation within an average of 2.4 years, providing insight into the long-term safety of these procedures. Another review found that this type of surgery is generally safe and effective for treating neck spine problems, often resulting in significant pain relief and improved function.
These findings are based on past studies and, while promising, do not guarantee results. It is important to discuss any concerns with a doctor when considering joining a trial.12345Why are researchers excited about this trial?
Researchers are excited about prophylactic bilateral cervical keyhole foraminotomy because it promises to reduce the risk of C5 palsy, a common complication after cervical decompression surgery. Unlike standard cervical decompression procedures, which don't address the potential nerve compression at the foramina, this technique proactively enlarges the foramina to prevent nerve pinching. By combining decompression with foraminotomy, there's hope to improve surgical outcomes and enhance patient recovery, offering a more comprehensive approach to preventing this specific type of nerve damage.
What evidence suggests that prophylactic foraminotomy is effective for reducing C5 palsy?
In this trial, participants will be divided into two groups to evaluate the effectiveness of prophylactic bilateral cervical keyhole foraminotomy in preventing C5 palsy. Research has shown that this surgical technique, used during neck surgery, might reduce the risk of C5 palsy, a condition that can cause muscle weakness and pain. One study found that this technique was less invasive and helped patients recover better after surgery. Another report showed that 85% of patients with nerve-related neck issues experienced symptom improvement after the procedure. These findings suggest that this technique could be a promising way to prevent C5 palsy. However, more research is needed to confirm its effectiveness for everyone undergoing neck surgery.12678
Who Is on the Research Team?
Thomas E Mroz, MD
Principal Investigator
The Cleveland Clinic
Are You a Good Fit for This Trial?
This trial is for Cleveland Clinic patients aged 18 or older with cervical myelopathy, scheduled for posterior cervical decompression at the C4-C5 level between 2016 and 2018. Excluded are those with preoperative deltoid muscle weakness, previous neck surgery, spinal cancer, trauma, or infection.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo cervical decompression surgery with or without prophylactic bilateral foraminotomy
Follow-up
Participants are monitored for C5 palsy and other complications post-surgery
What Are the Treatments Tested in This Trial?
Interventions
- Bilateral Cervical Keyhole Foraminotomy
- Cervical Decompression
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor
University of Southern California
Collaborator