Comparison of Cervical Laminectomy to Laminoplasty

Spinal Cord Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01324622
• Other study ID #: 2442
• Status: Terminated
• Phase: N/A
• First received: March 23, 2011
• Last updated: November 3, 2017
• Start date: January 1, 2006
• Est. completion date: November 1, 2010

Study information

• Verified date: October 2017
• Source: Synthes USA HQ, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: November 1, 2010
• Est. primary completion date: November 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Diseases

Intervention

Device:
• Laminoplasty
Utilizing the ARCH Fixation System (Study device)

Procedure:
• laminectomy
standard procedure

Locations

Country	Name	City	State
United States	Tower Orthopaedics	Beverly Hills	California
United States	Research Medical Center	Kansas City	Missouri
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Synthes USA HQ, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Sagittal Angle Success	Success defined as = +15º (kyphosis) as indicated by a neutral lateral radiograph	12 months
Primary	Incidence of Surgical Interventions	Success defined as a lack of revision, removal or addition of supplemental fixation.	up to 24 months
Secondary	Pain Scores on the Visual Analog Scale		Up to 24 months
Secondary	Functional Improvement Using the Neck Disability Index (NDI)		up to 24 months
Secondary	Quality of Life Improvement Using the SF-12 Scale		up to 24 months
Secondary	Motor Deficit		up to 24 months
Secondary	Reflex Evaluation		up to 24 months
Secondary	Sensory Deficit		up to 24 months
Secondary	Range of Motion		up to 24 months
Secondary	Sagittal Canal Diameter		up to 24 months
Secondary	Extent of Spinal Canal/Cord Decompression		up to 24 months