Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00285337
Status:
COMPLETED
Last Update Posted:
2017-11-01
First Post:
2006-02-01
Brief Title:
Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy
Sponsor:
AOSpine North America Research Network
Organization:
AOSpine North America Research Network
Study Overview
Official Title:
An Assessment of Surgical Techniques for Treating Cervical Spondylotic Myelopathy
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CSM
Brief Summary:
The primary purpose of this study is to compare anterior and posterior surgical approach in treatment of CSM in terms of surgical complications and neurological functional disease-specific and quality of life outcomes measures
Secondary aims are to quantify the amount of change pre and post-surgery concerning the same outcome measures to determine if there are differences in outcomes between posterior surgical techniques ie laminectomy with fusion or laminoplasty and examine the relationship between baseline MRI and baseline and follow-up neurological and functional outcomes
Secondary aims are to quantify the amount of change pre and post-surgery concerning the same outcome measures to determine if there are differences in outcomes between posterior surgical techniques ie laminectomy with fusion or laminoplasty and examine the relationship between baseline MRI and baseline and follow-up neurological and functional outcomes
Detailed Description:
Narrowing of the spinal canal by osteophytes ossification of the posterior longitudinal ligament or bulging of a large central disk can compress the cervical spinal cord and impinge the spinal nerve roots resulting in neck pain and various degrees of neurological symptoms and impairment2 In severe cases this can lead to stenosis of the cervical spine resulting in upper motor neuron symptoms in the lower extremity and lower motor neuron symptoms in the upper extremity When conservative measures such as traction cervical collar and postural exercises fail to prevent neurologic progression surgery may be indicated
A variety of surgical approaches and procedures are available and the optimal choice of treatment remains controversial Surgical procedures designed to decompress the spinal cord and in some cases stabilize the spine have been shown to be successful but there is a persistent percentage of patients who do not improve with surgical intervention3 Additionally the potential complications of surgery for CSM may depend on the various methods of surgical management Historically cervical laminectomy a posterior approach had been regarded as the standard surgical treatment of CSM However over the past 20 years it has been increasingly recognized that laminectomy without fusion is not appropriate for all patients and may result in instability and deformity Because of the instability caused by laminectomies alternate surgical approaches such as anterior approaches to the spine and laminoplasty have been developed and have gained increasing popularity over the years3 A range of factors must be considered when deciding which surgical technique to use Surgeons are often challenged with determining the most appropriate technique because there is limited information about whether there is a difference between surgical procedures in terms of clinical and radiographic outcomes in postoperative complication rates and in functional and quality of life outcomes Methods of treatment include conservative and surgical management Among surgically managed patients an anterior or posterior approach may be employed Among those managed posteriorly laminoplasty or laminectomy with fusion are common surgical techniques With several standards of care available for this population a better understanding of the corresponding positive and negative outcomes with respect to clinical and patient-centered outcomes is warranted
A variety of surgical approaches and procedures are available and the optimal choice of treatment remains controversial Surgical procedures designed to decompress the spinal cord and in some cases stabilize the spine have been shown to be successful but there is a persistent percentage of patients who do not improve with surgical intervention3 Additionally the potential complications of surgery for CSM may depend on the various methods of surgical management Historically cervical laminectomy a posterior approach had been regarded as the standard surgical treatment of CSM However over the past 20 years it has been increasingly recognized that laminectomy without fusion is not appropriate for all patients and may result in instability and deformity Because of the instability caused by laminectomies alternate surgical approaches such as anterior approaches to the spine and laminoplasty have been developed and have gained increasing popularity over the years3 A range of factors must be considered when deciding which surgical technique to use Surgeons are often challenged with determining the most appropriate technique because there is limited information about whether there is a difference between surgical procedures in terms of clinical and radiographic outcomes in postoperative complication rates and in functional and quality of life outcomes Methods of treatment include conservative and surgical management Among surgically managed patients an anterior or posterior approach may be employed Among those managed posteriorly laminoplasty or laminectomy with fusion are common surgical techniques With several standards of care available for this population a better understanding of the corresponding positive and negative outcomes with respect to clinical and patient-centered outcomes is warranted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None