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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperative, 2 weeks postoperative and 3 months postoperative
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am diagnosed with cervical myelopathy and will have surgery involving the C4-C5 area.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
C5 Palsy
Secondary outcome measures
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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
1,029 Previous Clinical Trials
1,364,598 Total Patients Enrolled
University of Southern CaliforniaOTHER
906 Previous Clinical Trials
1,595,808 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What site did they apply to?
Cleveland Clinic Foundation
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I am losing the use of my right hand and will no longer be able to use either hand.
PatientReceived no prior treatments
Recent research and studies
The Spine JournalJournal
Predicting C5 Palsy via the Use of Preoperative Anatomic Measurements
Lubelski, Daniel, Adeeb Derakhshan, Amy S. Nowacki, Jeffrey C. Wang, Michael P. Steinmetz, Edward C. Benzel, and Thomas E. Mroz. 2014. “Predicting C5 Palsy via the Use of Preoperative Anatomic Measurements”. The Spine Journal. Elsevier BV. doi:10.1016/j.spinee.2013.10.038.
The Spine JournalJournal
Prophylaxis of C5 Palsy After Cervical Expansive Laminoplasty by Bilateral Partial Foraminotomy
Komagata, Masashi, Makoto Nishiyama, Kenji Endo, Hitoshi Ikegami, Satoshi Tanaka, and Atsuhiro Imakiire. 2004. “Prophylaxis of C5 Palsy After Cervical Expansive Laminoplasty by Bilateral Partial Foraminotomy”. The Spine Journal. Elsevier BV. doi:10.1016/j.spinee.2004.03.022.
SpineJournal
Preventing C5 Palsy After Laminoplasty
Sasai, Kunihiko, Takanori Saito, Shigeo Akagi, Isashi Kato, Hiroyuki Ohnari, and Hirokazu Iida. 2003. “Preventing C5 Palsy After Laminoplasty”. Spine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.brs.0000083237.94535.46.
Surgical Neurology InternationalJournal
C5 Nerve Root Palsies Following Cervical Spine Surgery: A Review
Epstein, NancyE, and Renee Hollingsworth. 2015. “C5 Nerve Root Palsies Following Cervical Spine Surgery: A Review”. Surgical Neurology International. Scientific Scholar. doi:10.4103/2152-7806.156556.
All > Cervical Spondylotic Myelopathy
~33 spots leftby Dec 2024
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