Comparison of Cervical Laminectomy to Laminoplasty

NCT01324622 | Terminated Results

• 1 other identifier: 2442
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Spinal Cord Diseases

Keywords

Spinal Cord Diseases; Myelopathy; Myeloradiculopathy; Laminectomy; Laminoplasty

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

Study Arms (2)

Laminectomy

ACTIVE COMPARATOR

Control

Procedure: laminectomy

Laminoplasty

ACTIVE COMPARATOR

Treatment group

Device: Laminoplasty

Interventions

Laminoplasty DEVICE

Utilizing the ARCH Fixation System (Study device)

Also known as: ARCH Fixation System

Laminoplasty

laminectomy PROCEDURE

standard procedure

Laminectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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

Sponsors & Collaborators

• Synthes USA HQ, Inc.: lead

Study Sites (4)

Tower Orthopaedics

Beverly Hills, California, 90211, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related 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. doi: 10.1016/s1529-9430(02)00566-1.

  PMID: 14589250 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Diseases

Interventions

Laminoplasty; Laminectomy

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Orthopedic Procedures; Therapeutics; Neurosurgical Procedures; Surgical Procedures, Operative; Decompression, Surgical

Limitations and Caveats

Slow enrollment and a low follow-up rate resulted in the early termination of the study and lead to a small numbers of subjects completing the study and limiting the data analysis.

Results Point of Contact

• Title: Allyson Morris
• Organization: DePuy Synthes

amorris5@its.jnj.com

610-719-5298

Study Officials

• Carl Lauryssen, MD

  Tower Orthopaedics

  PRINCIPAL INVESTIGATOR

• Daniel Riew, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 29, 2011
• Study Start: January 1, 2006
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 7, 2017
• Results First Posted: April 17, 2017

Record last verified: 2017-10

Locations

US (4)