Predictors of Outcome and Natural History in Patients Wit... | NCT02936245

Studies
Predictors of Outcome and Natural History in Patients With Cervical Spondylotic Myelopathy

NCT02936245

Sponsor

Shanghai University of Traditional Chinese Medicine

Status

Unknown status

Last Update Posted

Oct 18, 2016Estimated

Enrollment

350Estimated

Phase

Not provided

Conditions

Cervical Spondylosis With Myelopathy

Interventions

no specific intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Dec 2019Estimated

Completion Date

Jul 2020Estimated

First Submitted Date

Oct 12, 2016

First Submission Date that Met QC Criteria

Oct 14, 2016

First Posted Date

Oct 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2016

Last Update Posted Date

Oct 18, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cervical spondylotic myelopathy (CSM) is the most frequent cause of myelopathy in those over the age of 50. They claim that surgical treatment of myelopathy, especially of the mild and moderate forms, has not shown better results than conservative treatment in the long term, and criteria for the indication and the timing of the operation have not been established. In order to get some more reliable data, a long-term follow up observational study will be started to confirm the effects of long term for conservative treatment.

Detailed Description

Cervical spondylotic myelopathy (CSM) is the most frequent cause of myelopathy in those over the age of 50 [1]. It is believed to have a generally progressive course over a period of years, with sudden acceleration especially following a slight head and neck injury, leading to significant disability [2, 3]. The treatment of CSM remains a problem, particularly in the mild and moderate forms without rapid progression.

Excellent outcomes for surgery have been presented in many studies. All of the studies, however, are retrospective, and many lack a clear design, standard criteria, control groups, and sufficient follow-up, so it is difficult to compare [4, 5, 6]. Furthermore, several studies and critical reviews are not so optimistic. They claim that surgical treatment of myelopathy, especially of the mild and moderate forms, has not shown better results than conservative treatment in the long term, and criteria for the indication and the timing of the operation have not been established [7, 8, 9]. Twenty-five percent of patients with laminoplasty suffer from severe neck and shoulder pain for more than 3 months [10], with significant morbidity from the iliac crest donor site etc. Surgery to decompress and stabilize the spine is often advocated for severe or progressive symptoms, with mixed results. About two-thirds of patients improve with surgery, whereas surgery is not successful in 15% to 30% of cases [11].

In order to get some more reliable data, a long-term follow up observational study will be started to confirm the effects of long term for conservative treatment.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

350Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no specific intervention	Other	We will not assign specific intervention in this research. We will record their baseline characteristics, received treatment, and assess the outcomes to analysis the predictors of outcome and natural history in patients with cervical spondylotic myelopathy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Japanese Orthopaedic Association scale	Japanese Orthopaedic Association scale assessed for 3 years	3 years

Secondary Outcomes

Measure	Description	Time Frame
Adverse Event	Adverse Event recorded 6 months, 1, 2, 3,4 and 5 years	6 months, 1, 2, 3,4 and 5 years
Visual Analogue Scale	Visual Analogue Scale assessed for 6 months, 1, 2, 3,4 and 5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical signs and symptoms of cervical cord dysfunction
Magnetic resonance imaging (MRI) criteria for cervical multisegmental cord compression and/or myelopathy due to spondylosis (including soft disc herniations) with or without developmentally narrow spinal canal
Age under 75 years
Patient's consent to conservative treatment It has been suggested that magnetic resonance imaging

Exclusion Criteria:

Spinal cord compression, without clinical symptoms
Previous surgery on the cervical spine
Uncertainty about the presence of significant additional diseases (such as Motor neurone disease, progressive polyarthritis)
Cervical cord dysfunction due to tumors, trauma, soft disc herniation or previous surgery
Serious that require a surgical procedure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with cervical spondylosis myelopathy caused by spondylosis (including soft disc herniations) with or without developmentally narrow spinal canal

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cui / Xue-jun, PhD	Contact	18917763017	64385700	13917715524@139.com
Yao / Min, PhD	Contact	13764102508		yaomin19871223@126.com

Overall Officials

Name	Affiliation	Role
Wang Yongjun, PhD	Longhua Hospital, Shanghai Universiy of Traditional Chinese Medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Longhua Hospital, Shanghai University of Traditional Chinese Medicine	Recruiting	Shanghai	Shanghai Municipality	200032	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10997531	Result	Young WF. Cervical spondylotic myelopathy: a common cause of spinal cord dysfunction in older persons. Am Fam Physician. 2000 Sep 1;62(5):1064-70, 1073.
8209553	Result	Law MD Jr, Bernhardt M, White AA 3rd. Cervical spondylotic myelopathy: a review of surgical indications and decision making. Yale J Biol Med. 1993 May-Jun;66(3):165-77.