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

NCT05767164 | Recruiting DMC

• 1 other identifier: KY20222157-C-1
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cervical Spinal Stenosis

Keywords

Cervical single open-door surgery; Cervical Spinal Stenosis; Open angle

Outcome Measures

Primary Outcomes (4)

• lamina open angle

  The Angle of opening of the cervical unilateral lamina while cervical single open-door surgery

  3 months after surgery

• JOA score change

  Japanese Orthopedic Association (JOA) score is used to assess the function of spinal cord which is in the form of questionnaires. Postoperative improvement rate = ((postoperative score - preoperative score)/ (17- preoperative score)) X100%. Improvement rate can also correspond to the commonly used efficacy criteria: cure when the improvement rate is 100%, effective when the improvement rate is greater than 60%, effective when 25-60%, and ineffective when less than 25%.

  pre-operation,3 months after surgery, 1 year after surgery

• NDI score change

  Neck Disability Index (NDI) score is used to assess the disorder of spinal cord which is in the form of questionnaires. Postoperative improvement rate = (total score)/ (numbers of programme X5) X100%. Improvement rate can also correspond to the commonly used efficacy criteria: the improvement rate when 60%-80% means extremely severe dysfunction, when 40%-60% means severe dysfunction, when 20-40% means moderate dysfunction, and when less than 20% means mild dysfunction.

  pre-operation,3 months after surgery, 1 year after surgery

• VAS score change

  A Visual Analogue Scale (VAS) is used to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. Using a ruler, the score is determined by measuring the distance (mm) on the 10cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.

  pre-operation,3 months after surgery

Secondary Outcomes (4)

• Maximum spinal cord compression change

  pre-operation,3 months after surgery, 1 year after surgery

• Compression ratio change

  pre-operation,3 months after surgery, 1 year after surgery

• transverse area change

  pre-operation,3 months after surgery, 1 year after surgery

• Sagittal Canal Diameter change

  pre-operation,3 months after surgery, 1 year after surgery

Study Arms (4)

Preoperative

NO INTERVENTION

postoperative (3 months)

EXPERIMENTAL

Procedure: cervical single open-door surgery

postoperative (6 months)

EXPERIMENTAL

Procedure: cervical single open-door surgery

postoperative (1 year)

EXPERIMENTAL

Procedure: cervical single open-door surgery

Interventions

cervical single open-door surgery PROCEDURE

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

postoperative (1 year); postoperative (3 months); postoperative (6 months)

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead
• Xi'an Honghui Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Tang-Du Hospital: collaborator

Study Sites (1)

Xijing Hospital

Xi'an, Shannxi Province, 710034, China

RECRUITING

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Central Study Contacts

Yanyan Jia

CONTACT

+862984771794; xiyyllwyh@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2023
• First Posted: March 14, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)