Spinal Cord DiseasesNCT01324622
Comparison of Cervical Laminectomy to Laminoplasty
A study testing Laminoplasty and laminectomy in people with Spinal Cord Diseases, run by Synthes USA HQ, Inc. at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Diseases
- What is being tested?
- Laminoplasty and laminectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jan 2006to 1 Nov 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Tower Orthopaedics
Beverly Hills, California, 90211
Research Medical Center
Kansas City, Missouri, 64132
Yale University School of Medicine
New Haven, Connecticut, 06520
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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
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.
Read the 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)
- Conditions
- Spinal Cord Diseases
- Being tested
- Laminoplasty, laminectomy
- Keywords
- Spinal Cord Diseases, Myelopathy, Myeloradiculopathy, Laminectomy, Laminoplasty
- Medical subject headings
- Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaminoplastyDevice
Also called ARCH Fixation System
Utilizing the ARCH Fixation System (Study device)
laminectomyProcedure or surgery
standard procedure
| Study group | Role | What they receive |
|---|---|---|
| Laminectomy | Active comparator | Control Receives: Procedure: laminectomy |
| Laminoplasty | Active comparator | Treatment group Receives: Device: Laminoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Sagittal Angle Success
Success defined as ≤ +15º (kyphosis) as indicated by a neutral lateral radiograph
Measured: 12 months
Incidence of Surgical Interventions
Success defined as a lack of revision, removal or addition of supplemental fixation.
Measured: up to 24 months
Secondary outcomes (9)
Pain Scores on the Visual Analog Scale
Measured: Up to 24 months
Functional Improvement Using the Neck Disability Index (NDI)
Measured: up to 24 months
Quality of Life Improvement Using the SF-12 Scale
Measured: up to 24 months
Motor Deficit
Measured: up to 24 months
Reflex Evaluation
Measured: up to 24 months
Sensory Deficit
Measured: up to 24 months
Range of Motion
Measured: up to 24 months
Sagittal Canal Diameter
Measured: up to 24 months
Extent of Spinal Canal/Cord Decompression
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study start1 Jan 2006
- Primary completion1 Nov 2010
- Study completion1 Nov 2010
Why it stopped: terminated due to failure to meet enrolment goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synthes USA HQ, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carl Lauryssen, MD, Principal investigator, Tower OrthopaedicsDaniel Riew, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01324622
- Sponsor's protocol ID
- 2442
- Status last verified
- Oct 2017
- First submitted
- 23 Mar 2011
- Last updated
- 7 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 14589250
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01324622
- Acronym / sponsor ID
- 2442
- Conditions
- Spinal Cord Diseases
- Keywords
- Spinal Cord Diseases, Myelopathy, Myeloradiculopathy, Laminectomy, Laminoplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated due to failure to meet enrolment goals
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Synthes USA HQ, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 1 Nov 2010 (actual)
- Study completion
- 1 Nov 2010 (actual)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Posted 17 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laminectomy | Active comparator | Procedure: laminectomyControl |
| Laminoplasty | Active comparator | Device: LaminoplastyTreatment group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaminoplastyAlso: ARCH Fixation SystemUtilizing the ARCH Fixation System (Study device) | Device | Laminoplasty |
| laminectomystandard procedure | Procedure or surgery | Laminectomy |
Primary outcome
Imrovement in Modified Japanese Orthopaedic Assessment (mJOA) Recovery Rate
Time frame: 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
Time frame: 12 months
Success defined as ≤ +15º (kyphosis) as indicated by a neutral lateral radiograph
Incidence of Surgical Interventions
Time frame: up to 24 months
Success defined as a lack of revision, removal or addition of supplemental fixation.
9 secondary outcomes
Pain Scores on the Visual Analog Scale
Time frame: Up to 24 months
Functional Improvement Using the Neck Disability Index (NDI)
Time frame: up to 24 months
Quality of Life Improvement Using the SF-12 Scale
Time frame: up to 24 months
Motor Deficit
Time frame: up to 24 months
Reflex Evaluation
Time frame: up to 24 months
Sensory Deficit
Time frame: up to 24 months
Range of Motion
Time frame: up to 24 months
Sagittal Canal Diameter
Time frame: up to 24 months
Extent of Spinal Canal/Cord Decompression
Time frame: up to 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14589250Edwards 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carl Lauryssen, MD principal investigator
Tower Orthopaedics
Daniel Riew, MD principal investigator
Washington University School of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laminoplasty and laminectomy in people with Spinal Cord Diseases, run by Synthes USA HQ, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imrovement in Modified Japanese Orthopaedic Assessment (mJOA) Recovery Rate (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01324622, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.