Surgery Techniques for Cervical Spondylosis

Not currently recruiting at 16 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lahey Clinic

Disqualifiers: Kyphosis, OPLL, Previous surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: Surgery and immediate recovery

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best surgical method for treating multi-level cervical spondylotic myelopathy (CSM), a common cause of spinal cord issues. Researchers aim to determine whether surgery from the front (ventral) or back (dorsal) of the neck more effectively improves physical health and symptoms like clumsy hands or difficulty walking. The study also examines which surgery uses fewer healthcare resources and how neck alignment after surgery affects recovery. Individuals with CSM who have at least two symptoms, such as clumsy hands or gait disturbance, might be suitable candidates for this trial. As an unphased trial, it offers patients the chance to contribute to valuable research that could enhance surgical outcomes for CSM.

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 these surgical techniques are safe for treating cervical spondylotic myelopathy?

Research has shown that both types of surgeries for treating cervical spondylotic myelopathy (CSM) are generally safe. For surgeries performed from the back of the neck (dorsal decompression), studies indicate that patients often experience significant improvements in spine function and alignment. However, there is a 15% to 25% chance of complications, meaning some patients might encounter issues after surgery.

Surgeries performed from the front of the neck (ventral decompression with fusion) are also considered safe. Many patients report less pain and improved nerve function afterward. This method typically causes less damage and bleeding, leading to a quicker recovery.

While both surgeries carry risks, research suggests that most patients achieve successful outcomes with either option. Participants should discuss any concerns with their healthcare providers to determine which surgery might be best for their specific situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the surgical techniques being tested for cervical spondylosis because they offer potentially improved approaches to managing this condition. Unlike traditional treatments that often address symptoms through medications or less targeted surgeries, these techniques focus on precise surgical interventions to decompress and stabilize affected areas. The dorsal decompression with fusion and dorsal laminoplasty aim to relieve pressure on the spinal cord from the back, potentially offering better preservation of movement compared to traditional fusion techniques. Meanwhile, the ventral decompression with fusion targets the issue from the front, which might be more effective for certain anatomical challenges. Together, these innovative approaches could lead to more tailored, effective treatment options for patients suffering from cervical spondylosis.

What evidence suggests that this trial's surgical techniques could be effective for cervical spondylosis?

Research has shown that both front (ventral) and back (dorsal) surgeries can improve symptoms for people with cervical spondylotic myelopathy (CSM). In this trial, participants will be assigned to either the Ventral Decompression with Fusion arm or the Dorsal arm, which includes Dorsal Decompression with Fusion or Dorsal Laminoplasty. Studies have found that front surgery, which involves relieving pressure and stabilizing the spine from the front, significantly benefits patients, with up to 84.3% experiencing better outcomes. Back surgery, which relieves pressure from the back, also leads to similar improvements in physical health. Both types of surgery effectively reduce symptoms and enhance quality of life, with front surgery offering slightly better results for certain conditions. The choice between these surgeries often depends on the specific needs and conditions of the patient. ^{2 6 7 8 9}

Who Is on the Research Team?

Zoher Ghogawala, MD

Principal Investigator

Lahey Clinic, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have severe spinal cord compression in multiple levels from C3 to C7.

You have at least two of the following symptoms: difficulty using your hands, trouble walking, overactive reflexes, toes that point upward when your foot is stimulated, or problems controlling your bladder.

Exclusion Criteria

You have a serious health condition that requires ongoing medical attention.

You have had surgery on your neck before.

Your neck has a curve of more than 5 degrees when standing straight.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Pre-operative imaging and assessments including cervical MRI, CT, and x-rays

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo either ventral or dorsal surgical approach for decompression/fusion

Surgery and immediate recovery

1 visit (in-person)

Post-operative Follow-up

Functional outcomes assessed using SF-36, Oswestry NDI, and EuroQol-5D at 3 months, 6 months, and 1 year

1 year

3 visits (in-person)

Long-term Follow-up

Annual assessments of functional outcomes and health resource utilization up to 5 years

5 years

Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dorsal (Back) Decompression with Fusion
• Dorsal (back) Laminoplasty
• Ventral (Front) decompression with Fusion

Trial Overview 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.

How Is the Trial Designed?

Group I: Dorsal Active Control 2 Interventions

Dorsal Decompression with Fusion or Dorsal Laminoplasty

Group II: Ventral Active Control 1 Intervention

Ventral Decompression with Fusion

Who Is Running the Clinical Trial?

Lahey Clinic

Lead Sponsor

Trials

74

Recruited

245,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11676656/

Long-Term Outcomes of Modified Expansive Open-Door ... Studies have shown that laminoplasty can also exacerbate preexisting kyphosis and contribute to segmental instability [22,23].

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2777236

Effect of Ventral vs Dorsal Spinal Surgery on Patient ... One-year SF-36 PCS mean improvement was not significantly different between ventral surgery (5.9 points) and dorsal surgery (6.2 points) ( ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7944378/

Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported ... Among patients with cervical spondylotic myelopathy undergoing cervical spinal surgery, a ventral approach did not significantly improve patient ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0967586814006006

Outcomes after cervical laminectomy with instrumented ... Our study suggests that cervical laminoplasty has significantly lower complication rates, similar long-term reoperation rates and lower healthcare resource ...

5. thejns.org thejns.org/spine/view/journals/j-neurosurg-spine/38/6/article-p631.xml

Anterior cervical discectomy and fusion versus posterior ... ACDF and PD are similar regarding functional outcomes. ACDF is beneficial in terms of less bleeding, shorter LOS, and lower odds of SSI and C5 palsy.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5429255/

Clinical outcome and safety study of a newly developed ... Our data show a significant improvement in JOA scores (4.8 points) at final follow-up as well as a significant 35% decrease in NDI scores, ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875021008950

Original Article Anterior Cervical Discectomy and Fusion ... ACDF resulted in fewer complications and readmissions compared with laminoplasty but was associated with greater costs.

8. mdpi.com mdpi.com/1648-9144/60/12/2057

Long-Term Outcomes of Modified Expansive Open-Door ... Results: At nine years post-surgery, patients demonstrated significant improvements in decompression and cervical alignment. The mean C2–C7 angle increased, ...

9. jss.amegroups.org jss.amegroups.org/article/view/4813/html

Complications following posterior cervical decompression and ... Complications occur for all types of surgery, but the literature suggests that a posterior approach for cervical fusion has a 15% to 25% risk compared to less ...