Comparison of Cervical Laminectomy to Laminoplasty

Stopped early · Not applicable

Conditions studied: Spinal Cord Diseases

In brief

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.

Key facts

Study ID

NCT01324622

Run by

Synthes USA HQ, Inc.

People needed

24

Starts

2006-01-01

Expected to finish

2010-11-01

Last updated by the study team

2017-12-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• Tower Orthopaedics — Beverly Hills, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Research Medical Center — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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