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Procedure

Surgery Techniques for Cervical Spondylosis

N/A

Waitlist Available

Led By Zoher Ghogawala, MD

Research Sponsored by Lahey Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year and 2 year

Awards & highlights

Study Summary

This trial will help researchers understand whether ventral or dorsal surgery is better for patients with CSM.

Who is the study for?

This trial is for adults with cervical spondylotic myelopathy, which means they have spinal cord compression at multiple levels from C3 to C7 and symptoms like clumsy hands or walking problems. They shouldn't have had previous neck surgery or certain spine deformities, and must be healthy enough for anesthesia.Check my eligibility

What is being tested?

The study compares two types of neck surgery to see which is better for multi-level spinal cord injury: ventral (front) decompression with fusion versus dorsal (back) approaches including fusion and laminoplasty. It measures physical function outcomes and health resource use after one year.See study design

What are the potential side effects?

Potential side effects include typical surgical risks such as infection, bleeding, pain at the site of operation, nerve damage that could affect movement or sensation, complications from anesthesia, and possibly a longer recovery time.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year and 2 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year and 2 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year and 2 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measurement of Change in Short Form 36 (SF 36) Physical Component Score (PCS) From Baseline to 1 Year and 2 Year

Secondary outcome measures

Cumulative Health Resource Utilization Over 1 Year by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty

EuroQol-5D

Modified Japanese Orthopedic Association Score mJOA

+6 more

Other outcome measures

Short Form-36 (SF-36) Physical Component Summary (PCS) Score by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty

Trial Design

2Treatment groups

Active Control

Group I: DorsalActive Control2 Interventions

Dorsal Decompression with Fusion or Dorsal Laminoplasty

Group II: VentralActive Control1 Intervention

Ventral Decompression with Fusion

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Lahey ClinicLead Sponsor

72 Previous Clinical Trials

244,976 Total Patients Enrolled

Patient-Centered Outcomes Research InstituteOTHER

549 Previous Clinical Trials

29,996,279 Total Patients Enrolled

Zoher Ghogawala, MDPrincipal InvestigatorLahey Clinic, Inc.

5 Previous Clinical Trials

1,053 Total Patients Enrolled

Frequently Asked Questions

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

To whom is this clinical trial open for enrollment?

"Eligible patients for this spondylosis study must be aged between 45 and 80 years old. To meet the criteria, they must have CSM at 2 or more levels from C3 to C7 as well as present 2 or more of the following: clumsy hands, gait disturbance, hyperreflexia, up going toes, bladder dysfunction."

Answered by AI

Does the age limit for this clinical trial extend to those under seventy years old?

"The age range for this study is 45 to 80 years old."

Answered by AI

Are we still enrolling people for this experiment?

"The trial you are asking about is no longer enrolling patients, as noted on clinicaltrials.gov. The study was originally posted on 4/1/2014 and was last edited on 10/21/2022; however, there are 83 other trials that are currently recruiting."

Answered by AI

At how many hospitals is this experiment being carried out?

"This trial has 16 different centres where it is currently being conducted. Some notable locations are University Health Network-University of Toronto in Toronto, University of Utah Health Sciences in Salt Lake City, and Hospital for Special Surgery in New york."

Answered by AI

Recent research and studies

NeurosurgeryJournal

Comparative Effectiveness of Ventral Vs Dorsal Surgery for Cervical Spondylotic Myelopathy

Ghogawala, Zoher, Brook Martin, Edward C Benzel, James Dziura, Subu N Magge, Khalid M Abbed, Erica F Bisson, et al.. 2011. “Comparative Effectiveness of Ventral Vs Dorsal Surgery for Cervical Spondylotic Myelopathy”. Neurosurgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1227/neu.0b013e31820777cf.

SpineJournal

Ventral Versus Dorsal Decompression for Cervical Spondylotic Myelopathy: Surgeonsʼ Assessment of Eligibility for Randomization in a Proposed Randomized Controlled Trial

Ghogawala, Zoher, Jean-Valery Coumans, Edward C. Benzel, Lauren M. Stabile, and Fred G. Barker II. 2007. “Ventral Versus Dorsal Decompression for Cervical Spondylotic Myelopathy: Surgeonsʼ Assessment of Eligibility for Randomization in a Proposed Randomized Controlled Trial”. Spine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.brs.0000255068.94058.8a.

NeurosurgeryJournal

Cervical Spondylotic Myelopathy Surgical Trial

Ghogawala, Zoher, Edward C. Benzel, Robert F. Heary, K. Daniel Riew, Todd J. Albert, William E. Butler, Fred G. Barker, et al.. 2014. “Cervical Spondylotic Myelopathy Surgical Trial”. Neurosurgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1227/neu.0000000000000479.

SpineJournal