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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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Measurement of Change in Short Form 36 (SF 36) Physical Component Score (PCS) From Baseline to 1 Year and 2 Year
Secondary study objectives
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 study objectives
Short Form-36 (SF-36) Physical Component Summary (PCS) Score by Actual Treatment Groups - Ventral Fusion, Dorsal Fusion, and Dorsal Laminoplasty

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Lahey ClinicLead Sponsor
72 Previous Clinical Trials
244,789 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
574 Previous Clinical Trials
27,078,690 Total Patients Enrolled
Zoher Ghogawala, MDPrincipal InvestigatorLahey Clinic, Inc.
5 Previous Clinical Trials
1,053 Total Patients Enrolled
~23 spots leftby Nov 2025
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