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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01324622

Enrollment

Registered

2011-03-29

Start date

2006-01-01

Completion date

2010-11-01

Last updated

2017-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Diseases

Keywords

Spinal Cord Diseases, Myelopathy, Myeloradiculopathy, Laminectomy, Laminoplasty

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.

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)

Interventions

DEVICELaminoplasty

Utilizing the ARCH Fixation System (Study device)

PROCEDURElaminectomy

standard procedure

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Imrovement in Modified Japanese Orthopaedic Assessment (mJOA) Recovery Rate	12 months	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
Sagittal Angle Success	12 months	Success defined as ≤ +15º (kyphosis) as indicated by a neutral lateral radiograph
Incidence of Surgical Interventions	up to 24 months	Success defined as a lack of revision, removal or addition of supplemental fixation.

Secondary

Measure	Time frame
Motor Deficit	up to 24 months
Reflex Evaluation	up to 24 months
Sensory Deficit	up to 24 months
Pain Scores on the Visual Analog Scale	Up to 24 months
Sagittal Canal Diameter	up to 24 months
Extent of Spinal Canal/Cord Decompression	up to 24 months
Range of Motion	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

Countries

United States

Participant flow

Participants by arm

Arm	Count
Laminectomy Active Comparator: Laminectomy Control, Standard Procedure	13
Laminoplasty Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers	11
Total	24

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	1	0
Overall Study	Lack of Efficacy	1	0
Overall Study	Lost to Follow-up	7	7

Baseline characteristics

Characteristic	Laminectomy	Laminoplasty	Total
Age, Continuous	57 years STANDARD_DEVIATION 10	59 years STANDARD_DEVIATION 12	58 years STANDARD_DEVIATION 11
BMI	29 kg/m2 STANDARD_DEVIATION 7	30 kg/m2 STANDARD_DEVIATION 4	30 kg/m2 STANDARD_DEVIATION 6
Region of Enrollment United States	13 participants	11 participants	24 participants
Sex: Female, Male Female	8 Participants	3 Participants	11 Participants
Sex: Female, Male Male	5 Participants	8 Participants	13 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	3 / 13	1 / 11
serious Total, serious adverse events	0 / 13	1 / 11

Outcome results

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

Time frame: 12 months

Population: Number of participants with 12-month follow-up data.

Arm	Measure	Value (NUMBER)
Laminectomy	Imrovement in Modified Japanese Orthopaedic Assessment (mJOA) Recovery Rate	10 participants with mJOA Recovery Rate ≥0
Laminoplasty	Imrovement in Modified Japanese Orthopaedic Assessment (mJOA) Recovery Rate	10 participants with mJOA Recovery Rate ≥0

Primary

Incidence of Surgical Interventions

Success defined as a lack of revision, removal or addition of supplemental fixation.

Time frame: up to 24 months

Arm	Measure	Value (NUMBER)
Laminectomy	Incidence of Surgical Interventions	10 participants w/o surgical intervention
Laminoplasty	Incidence of Surgical Interventions	13 participants w/o surgical intervention

Primary

Sagittal Angle Success

Success defined as ≤ +15º (kyphosis) as indicated by a neutral lateral radiograph

Time frame: 12 months

Population: Number of participants with radiographic data available at 12 month visit

Arm	Measure	Value (NUMBER)
Laminectomy	Sagittal Angle Success	8 participants with ≤15° sagittal angle
Laminoplasty	Sagittal Angle Success	5 participants with ≤15° sagittal angle

Secondary