NCT02936245

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

6.2 years

First QC Date

October 12, 2016

Last Update Submit

October 14, 2016

Conditions

Cervical Spondylosis With Myelopathy

Outcome Measures

Primary Outcomes (1)

  • Japanese Orthopaedic Association scale

    Japanese Orthopaedic Association scale assessed for 3 years

    3 years

Secondary Outcomes (5)

  • Adverse Event

    6 months, 1, 2, 3,4 and 5 years

  • Visual Analogue Scale

    6 months, 1, 2, 3,4 and 5 years

  • the Medical Outcomes Study short form health survey-36

    6 months, 1, 2, 3,4 and 5 years

  • Neck Disability Index

    6 months, 1, 2, 3,4 and 5 years

  • Japanese Orthopaedic Association scale

    6 months, 1, 2, 4 and 5 years

Interventions

no specific interventionOTHER

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 10997531RESULT

  • 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.

    PMID: 8209553RESULT

  • Rowland LP. Surgical treatment of cervical spondylotic myelopathy: time for a controlled trial. Neurology. 1992 Jan;42(1):5-13. doi: 10.1212/wnl.42.1.5.

    PMID: 1734322RESULT

Related Links

Study Officials

  • Wang Yongjun, PhD

    Longhua Hospital, Shanghai Universiy of Traditional Chinese Medicine

    STUDY CHAIR

Central Study Contacts

Cui / Xue-jun, PhD

CONTACT

1891776301713917715524@139.com

Yao / Min, PhD

CONTACT

13764102508yaomin19871223@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 18, 2016

Study Start

October 1, 2013

Primary Completion

December 1, 2019

Study Completion

July 1, 2020

Last Updated

October 18, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

individual participant data (IPD) available

Locations

CN(1)