Cervical Spondylotic Myelopathy - Cost Observational Surgical Trial

NCT05994404 | Completed DMC

• 2 other identifiers: LCID: 2023CE-1304-6173
• Study Type: observational
• Target: 269
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of the study is to determine the cost-effectiveness of different surgical strategies to treat cervical spondylotic myelopathy. The study will use data generated from the CSM-S Trial (NCT02076113).

1. 1.To determine if laminoplasty is more cost-effective compared to dorsal fusion or ventral fusion surgery.
2. 2.To determine the relative cost-effectiveness between anterior cervical discectomy and fusion (ACDF), posterior instrumented cervical fusion (PCF), and cervical laminoplasty.

Conditions

Cervical Spondylosis With Myelopathy

Keywords

cost-effectiveness; cervical spondylotic myelopathy; health resource utilization; spinal fusion; laminoplasty

Outcome Measures

Primary Outcomes (1)

• Total Health Costs - Societal Perspective

  Index hospitalization costs+one-year all cause costs+loss of productivity costs

  5 years

Secondary Outcomes (3)

• Index Hospitalization Costs

  30 days

• 1-Year all-cause health costs

  1 year

• Loss of productivity costs

  5 years

Study Arms (3)

Anterior Cervical Discectomy and Fusion

Ventral decompression and fusion was performed using multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft was used at each disc space and all compressive osteophytes were removed using the operating microscope. Plate fixation was done with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.

Procedure: ACDF

Posterior Instrumented Cervical Fusion

Dorsal decompression and instrumented fusion was performed using midline cervical laminoectom with the application of lateral mass screws and rods for rigid fixation. Local bone was used along with allograft to promote a lateral mass fusion.

Procedure: Posterior Cervical Fusion

Laminoplasty

Laminoplasty was performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) were used with titanium plates and screws to expand the spinal canal diameter.

Procedure: Cervical Laminoplasty

Interventions

ACDF PROCEDURE

Anterior Cervical Discectomy and Fusion

Posterior Cervical Fusion PROCEDURE

Posterior Instrumented Cervical Fusion

Cervical Laminoplasty PROCEDURE

Laminoplasty

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population consists of patients with multi-level cervical spondylotic myelopathy without kyphosis and who satisfied clinical equipoise criteria (ventral vs. dorsal approach) as judged by a panel of at least 15 spine experts.

You may qualify if:

• Patients with Cervical Myelopathy (\> or equal to 2 levels of spinal cord compression from C3 to C7) with 2 or more of the following symptoms/ signs: clumsy hands, gait disturbance, hyperreflexia, upgoing toes, bladder dysfunction.

You may not qualify if:

• C2-C7 kyphosis\>5 degrees (measured in standing extension radiograph)
• segmental kyphotic deformity (defined by greater than 3 osteophytes extending dorsal to a C2-C7 dorsal-caudal line measured on cervical spine CT)
• structurally significant ossification of the posterior longitudinal ligament (OPLL - measured on cervical spine CT)
• previous cervical spine surgery, or significant active health-related co-morbidity (Anesthesia Class IV or higher)

Sponsors & Collaborators

• Lahey Clinic: lead
• Mayo Clinic: collaborator

Study Sites (2)

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01803, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Related Publications (1)

• Ghogawala Z, Terrin N, Dunbar MR, Breeze JL, Freund KM, Kanter AS, Mummaneni PV, Bisson EF, Barker FG 2nd, Schwartz JS, Harrop JS, Magge SN, Heary RF, Fehlings MG, Albert TJ, Arnold PM, Riew KD, Steinmetz MP, Wang MC, Whitmore RG, Heller JG, Benzel EC. Effect of Ventral vs Dorsal Spinal Surgery on Patient-Reported Physical Functioning in Patients With Cervical Spondylotic Myelopathy: A Randomized Clinical Trial. JAMA. 2021 Mar 9;325(10):942-951. doi: 10.1001/jama.2021.1233.

  PMID: 33687463 RESULT

Study Officials

• Zoher Ghogawala, MD

  Lahey Hospital & Medical Center

  STUDY DIRECTOR

• Robert G. Whitmore, MD

  Lahey Hospital & Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 16, 2023
• Study Start: April 1, 2014
• Primary Completion: March 30, 2018
• Study Completion: April 1, 2019
• Last Updated: August 16, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within 6 months of primary publication of the data and for 5 years thereafter
• Access Criteria: Researchers with a clear and valid research protocol will be able to gain access to the data.

Locations

US (2)