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Procedure

Prophylactic Foraminotomy for C5 Palsy

N/A
Recruiting
Led By Thomas E Mroz, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cleveland Clinic patients who have been diagnosed with cervical myelopathy, without radiculopathy, and will undergo posterior cervical decompression involving the C4-C5 interspace between 2016 and 2018. This includes patients undergoing cervical laminoplasty and cervical laminectomy and fusion.
Be older than 18 years old
Must not have
Any patient younger than 18 years of age will not be included on the basis of skeletal immaturity.
Any patients who have undergone previous cervical spine surgery, or who have any spinal malignancy, trauma or infection will be excluded in order to eliminate the confounding effect of multiple surgical interventions.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperative, 2 weeks postoperative and 3 months postoperative
Awards & highlights

Summary

This trial will study whether prophylactic foraminotomy, a surgical procedure involving the removal of bone to enlarge the space around the nerve root, can help reduce the incidence of C5P.

Who is the study for?
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.
What is being tested?
The study tests if a preventive procedure called bilateral foraminotomy can reduce the risk of C5 palsy after cervical decompression surgery. It's a randomized trial across multiple centers where some patients will receive this additional intervention during their surgery.
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include discomfort at the surgical site, nerve damage symptoms like numbness or weakness in arms/hands, and general surgical complications such as infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am diagnosed with cervical myelopathy and will have surgery involving the C4-C5 area.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am 18 years old or older.
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I have not had cervical spine surgery or any spinal cancer, trauma, or infection.
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I do not have severe weakness in my shoulder muscle.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preoperative, 2 weeks postoperative and 3 months postoperative
This trial's timeline: 3 weeks for screening, Varies for treatment, and preoperative, 2 weeks postoperative and 3 months postoperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
C5 Palsy
Secondary study objectives
Back
Blood loss
Emergency department visit
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Foraminotomy GroupExperimental Treatment2 Interventions
Prophylactic bilateral cervical keyhole foraminotomy will be done in addition to their decompression surgery
Group II: Control GroupActive Control1 Intervention
Cervical decompression will be done without prophylactic bilateral foraminotomy

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,045 Previous Clinical Trials
1,370,195 Total Patients Enrolled
University of Southern CaliforniaOTHER
936 Previous Clinical Trials
1,613,001 Total Patients Enrolled
Thomas E Mroz, MDPrincipal InvestigatorThe Cleveland Clinic

Media Library

Cervical Decompression (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03023696 — N/A
Cervical Radiculopathy Research Study Groups: Foraminotomy Group, Control Group
Cervical Radiculopathy Clinical Trial 2023: Cervical Decompression Highlights & Side Effects. Trial Name: NCT03023696 — N/A
Cervical Decompression (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03023696 — N/A
~9 spots leftby Dec 2024
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