Surgery Techniques for Cervical Spondylosis

Recruiting at 15 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

269 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Dorsal Decompression with Fusion, Dorsal Laminoplasty, and Ventral decompression with Fusion for Cervical Spondylosis?

Research shows that both dorsal and ventral decompression techniques, including laminoplasty and anterior discectomy, are effective for treating cervical spondylosis, with many patients experiencing improvement. However, the choice of technique should be tailored to the patient's specific condition to achieve the best outcomes. ^{1 2 3 4 5}

Is surgery for cervical spondylosis generally safe?

Surgery for cervical spondylosis, including both ventral (front) and dorsal (back) decompression and fusion techniques, is generally considered safe, but it does have some risks. Complication rates for ventral fusion range from 11% to 13.6%, while dorsal fusion has slightly higher rates, from 16.4% to 19%. Minimally invasive techniques aim to reduce these risks and postoperative pain. ^{1 2 4 6 7}

How does the treatment 'Dorsal Decompression with Fusion, Dorsal Laminoplasty, Ventral Decompression with Fusion' differ from other treatments for cervical spondylosis?

This treatment is unique because it combines both dorsal (back) and ventral (front) surgical approaches to relieve pressure on the spinal cord and nerves, potentially reducing complications like postoperative kyphosis (forward bending of the spine) and improving neurological function. The use of minimally invasive techniques in dorsal procedures aims to minimize disruption to the neck's supporting structures, which may lead to less pain and fewer deformities after surgery. ^{1 2 8 9 10}

What is the purpose of this trial?

The purpose of the study is to determine the optimal surgical approach (ventral vs dorsal) for patients with multi-level cervical spondylotic myelopathy (CSM). There are no established guidelines for the management of patients with CSM, which represents the most common cause of spinal cord injury and dysfunction in the US and in the world. This study aims to test the hypothesis that ventral surgery is associated with superior Short Form-36 physical component Score (SF-36 PCS) outcome at one year follow-up compared to dorsal approaches and that both ventral and dorsal surgery improve symptoms of spinal cord dysfunction measured using the modified Japanese Orthopedic Association Score (mJOA). A secondary hypothesis is that health resource utilization for ventral surgery, dorsal fusion, and laminoplasty surgery are different. A third hypothesis is that cervical sagittal balance post-operatively is a significant predictor of SF-36 PCS outcome.

Research Team

Zoher Ghogawala, MD

Principal Investigator

Lahey Clinic, Inc.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. Egypt pubmed.ncbi.nlm.nih.gov

Operative techniques for cervical radiculopathy and myelopathy. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Minimally invasive surgery for the management of cervical spondylosis. [2007]

3. China pubmed.ncbi.nlm.nih.gov

[Case-control study of anterior cervical decompression plus sublevel fusion and posterior cervical laminoDIastv for the treatment of multilevel cervical spondylotic myelopathy]. [2016]

4. Germany pubmed.ncbi.nlm.nih.gov

Cervical spondylotic myelopathy: posterior decompression and pedicle screw fixation. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Cervical spondylosis: a review of 230 cases. [2016]

6. Austria pubmed.ncbi.nlm.nih.gov

Minimally invasive disc preserving surgery in cervical radiculopathies: the posterior microscopic and endoscopic approach. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Ventral fusion versus dorsal fusion: determining the optimal treatment for cervical spondylotic myelopathy. [2022]

8. Japan pubmed.ncbi.nlm.nih.gov

[Posterior Surgical Techniques for Cervical Spine]. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Cervical spondylotic myelopathy: surgical decision making. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Multilevel cervical spondylosis. Laminoplasty versus anterior decompression. [2019]