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Recruiting NCT05767164

Correlation Between Parameters and Prognosis of Cervical Single Open-door Surgery

No phase Interventional Cervical Spinal Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cervical single open-door surgery.
Who it may be relevant to
Registry conditions: Cervical Spinal Stenosis. Basic parameters: 18 years — 86 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Correlation Between Parameters and Prognosis of Cervical Single Open-door Surgery: a Multicenter Retrospective Clinical Study

Overview

The aim of study was evaluated the relationship between the relevant evaluation indexes of cervical spine open-door surgery, prognosis and complication rate, and provided theoretical basis for personalized surgical program through multi-center retrospective clinical study

Interventions

  • Procedure cervical single open-door surgery
    The patients were operated by the cervical single open-door surgery, which were used with the Centerpiece titanium plate to internal fixation.

Primary outcome measures

  • lamina open angle [Time frame: 3 months after surgery]
  • JOA score change [Time frame: pre-operation,3 months after surgery, 1 year after surgery]
  • NDI score change [Time frame: pre-operation,3 months after surgery, 1 year after surgery]
  • VAS score change [Time frame: pre-operation,3 months after surgery]
Secondary outcome measures (4)
  • Maximum spinal cord compression change [Time frame: pre-operation,3 months after surgery, 1 year after surgery]
  • Compression ratio change [Time frame: pre-operation,3 months after surgery, 1 year after surgery]
  • transverse area change [Time frame: pre-operation,3 months after surgery, 1 year after surgery]
  • Sagittal Canal Diameter change [Time frame: pre-operation,3 months after surgery, 1 year after surgery]

Eligibility criteria

Inclusion criteria

  • Symptoms and signs of the patients were typical. MRI showed single or multiple central herniation of C3-C7 intervertebral discs or spinal stenosis at corresponding levels, which confirmed cervical myeloid cervical spondylosis or cervical spinal stenosis.
  • Conservative treatment for more than 3 months before surgery was ineffective.
  • The patients underwent cervical single open-door surgery.
  • Informed consent was obtained from the patient and his family, informed consent was signed, and a complete follow-up was completed after surgery

Exclusion criteria

  • Cervical spondylotic radiculopathy.
  • Cervical kyphosis or instability.
  • Cervical spondylosis caused by trauma, tumor, tuberculosis and metabolic diseases.
  • Revision surgery or combined anterior-posterior surgery is required.
  • The patients had severe neurological diseases affecting the evaluation of postoperative results.
  • Psychopath.
  • MRI or CT for contraindications.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Xijing Hospital — Xi'an

Publications

  • Hirabayashi K, Miyakawa J, Satomi K, Maruyama T, Wakano K. Operative results and postoperative progression of ossification among patients with ossification of cervical posterior longitudinal ligament. Spine (Phila Pa 1976). 1981 Jul-Aug;6(4):354-64. doi: 10.1097/00007632-198107000-00005. PMID 6792717
  • Karpova A, Arun R, Davis AM, Kulkarni AV, Massicotte EM, Mikulis DJ, Lubina ZI, Fehlings MG. Predictors of surgical outcome in cervical spondylotic myelopathy. Spine (Phila Pa 1976). 2013 Mar 1;38(5):392-400. doi: 10.1097/BRS.0b013e3182715bc3. PMID 23448898
  • Nouri A, Tetreault L, Zamorano JJ, Dalzell K, Davis AM, Mikulis D, Yee A, Fehlings MG. Role of magnetic resonance imaging in predicting surgical outcome in patients with cervical spondylotic myelopathy. Spine (Phila Pa 1976). 2015 Feb 1;40(3):171-8. doi: 10.1097/BRS.0000000000000678. PMID 25668335
  • Torg JS, Pavlov H, Genuario SE, Sennett B, Wisneski RJ, Robie BH, Jahre C. Neurapraxia of the cervical spinal cord with transient quadriplegia. J Bone Joint Surg Am. 1986 Dec;68(9):1354-70. PMID 3782207
  • Yeh KT, Lee RP, Chen IH, Yu TC, Liu KL, Peng CH, Wang JH, Wu WT. Laminoplasty instead of laminectomy as a decompression method in posterior instrumented fusion for degenerative cervical kyphosis with stenosis. J Orthop Surg Res. 2015 Sep 4;10:138. doi: 10.1186/s13018-015-0280-y. PMID 26338009
  • Pavlov H, Torg JS, Robie B, Jahre C. Cervical spinal stenosis: determination with vertebral body ratio method. Radiology. 1987 Sep;164(3):771-5. doi: 10.1148/radiology.164.3.3615879. PMID 3615879
  • Blackley HR, Plank LD, Robertson PA. Determining the sagittal dimensions of the canal of the cervical spine. The reliability of ratios of anatomical measurements. J Bone Joint Surg Br. 1999 Jan;81(1):110-2. doi: 10.1302/0301-620x.81b1.9001. PMID 10068016
  • Prasad SS, O'Malley M, Caplan M, Shackleford IM, Pydisetty RK. MRI measurements of the cervical spine and their correlation to Pavlov's ratio. Spine (Phila Pa 1976). 2003 Jun 15;28(12):1263-8. doi: 10.1097/01.BRS.0000065570.20888.AA. PMID 12811269

Identifiers

NCT: NCT05767164 · KY20222157-C-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗