Comparison of Cervical Laminectomy to Laminoplasty

Comparison of Cervical Laminectomy to Cervical Laminoplasty* in Patients With Cervical Myelopathy or Myeloradiculopathy Due to Multiple Level Cervical Spinal Canal Stenosis * ARCH™ Fixation System by SYNTHES

The objective of this study is to compare the clinical and radiographic outcomes of multi-level laminectomy to multi-level laminoplasty in the treatment of patients with cervical myelopathy or myeloradiculopathy. The hypothesis for the study is that the laminoplasty group is not inferior to the laminectomy group.

Study Overview

• Status: Terminated
• Conditions: Spinal Cord Diseases
• Intervention / Treatment: Procedure: laminectomy; Device: Laminoplasty

Detailed Description

Historically, cervical laminectomy has been proven to be effective in the treatment of symptomatic patients with cervical myelopathy. This standard procedure is employed to accomplish posterior decompression of the cervical spinal cord in patients with multi-level cervical spinal stenosis who have normal or near normal cervical spinal curvature and alignment without associated instability. Laminoplasty was developed in Japan as an alternative to the laminectomy procedure with the intent to reduce post-operative morbidity after dorsal cervical spinal cord decompression, neck pain and to maintain the relative stability of the cervical spine after multi-level decompression.

The goal of both the laminoplasty and laminectomy procedures is to provide spinal cord decompression by enlargement of the spinal canal. A potential benefit of laminoplasty compared to laminectomy is to preserve stability and range of motion of the cervical spine without complete disruption/removal of the posterior laminae, spinous processes and interspinous ligamentous structures. Various authors have described different laminoplasty techniques; all preserve the lamina and expand the size of the spinal canal by fixing the freed or partially freed lamina in a more posterior position.

The primary study hypothesis is that, patients treated with laminoplasty with ARCH fixation (Treatment Group) have clinical and radiographic outcomes as assessed by valid outcomes measures, is not inferior to patients treated with laminectomy (Control Group)

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Tower Orthopaedics
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University School Of Medicine
  • Missouri
    • Kansas City, Missouri, United States, 64132
      • Research Medical Center
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: All must be met for inclusion in the study.

• The patient must be at least 18 years of age and have no evidence of developmental anomaly of the cranial cervical junction and/or cervical spine
• The patient has the diagnosis of cervical myelopathy
• The myelopathy or myeloradiculopathy requires a posterior cervical decompression of the spinal canal involving two or more contiguous intervertebral levels including and between C3 and C7
• The patient signs the study informed consent form.

Exclusion Criteria:

• Primary symptoms and signs of cervical radiculopathy (only) without myelopathy.
• Presence of primary focal anterior compression of the cervical spinal cord.
• Ossification of the ligamentum flavum.
• Previous surgery of the cervical spine.
• Tumor, infection, or trauma of the cervical spine or cord.
• Segmental instability - Pregnant or interested in becoming pregnant during the study follow-up period.
• Known sensitivity to device materials.
• Currently being treated or intends to be treated postoperatively with other devices for the same disorder (e.g., electrical stimulation devices, pain control devices, etc.).
• Currently a participant in any other study related to the treatment of cervical spinal disorders.
• Prisoner
• Mentally incompetent, or unable to comply with the follow up regime

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laminectomy; Control	Procedure: laminectomy; standard procedure
Active Comparator: Laminoplasty; Treatment group	Device: Laminoplasty; Utilizing the ARCH Fixation System (Study device); Other Names: ARCH Fixation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Imrovement in Modified Japanese Orthopaedic Assessment (mJOA) Recovery Rate	Number of participants who have mJOA Recovery Rate ≥0%. mJOA Recovery Rate is defined as: mJOA Recovery Rate = ((PostOp Score-PreOp Score)/(17 - Pre-Op Score))*100	12 months
Sagittal Angle Success	Success defined as ≤ +15º (kyphosis) as indicated by a neutral lateral radiograph	12 months
Incidence of Surgical Interventions	Success defined as a lack of revision, removal or addition of supplemental fixation.	up to 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain Scores on the Visual Analog Scale	Up to 24 months
Functional Improvement Using the Neck Disability Index (NDI)	up to 24 months
Quality of Life Improvement Using the SF-12 Scale	up to 24 months
Motor Deficit	up to 24 months
Reflex Evaluation	up to 24 months
Sensory Deficit	up to 24 months
Range of Motion	up to 24 months
Sagittal Canal Diameter	up to 24 months
Extent of Spinal Canal/Cord Decompression	up to 24 months

Collaborators and Investigators

• Sponsor: Synthes USA HQ, Inc.
• Investigators: Principal Investigator: Carl Lauryssen, MD, Tower Orthopaedics; Principal Investigator: Daniel Riew, MD, Washington University School of Medicine

Publications and helpful links

General Publications

• Edwards CC 2nd, Riew KD, Anderson PA, Hilibrand AS, Vaccaro AF. Cervical myelopathy. current diagnostic and treatment strategies. Spine J. 2003 Jan-Feb;3(1):68-81. doi: 10.1016/s1529-9430(02)00566-1.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2006
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: March 23, 2011
• First Submitted That Met QC Criteria: March 28, 2011
• First Posted (Estimate): March 29, 2011

Study Record Updates

• Last Update Posted (Actual): December 7, 2017
• Last Update Submitted That Met QC Criteria: November 3, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Myelopathy; Laminectomy; Spinal Cord Diseases; Laminoplasty; Myeloradiculopathy
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases
• Other Study ID Numbers: 2442