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

NCT ID: NCT05767164

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Spinal Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Preoperative

Group Type NO_INTERVENTION

No interventions assigned to this group

postoperative (3 months)

Group Type EXPERIMENTAL

cervical single open-door surgery

Intervention Type PROCEDURE

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

postoperative (6 months)

Group Type EXPERIMENTAL

cervical single open-door surgery

Intervention Type 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)

Group Type EXPERIMENTAL

cervical single open-door surgery

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xi'an Honghui Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Tang-Du Hospital

OTHER

Sponsor Role collaborator

Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Xijing Hospital

Xi'an, Shannxi Province, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yanyan Jia

Role: CONTACT

+862984771794

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Wei Qi, Doctor

Role: primary

15902984776

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 6792717 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23448898 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25668335 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3782207 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26338009 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3615879 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10068016 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12811269 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KY20222157-C-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Upper Cross Syndrome and Neck Proprioception
NCT06801613 NOT_YET_RECRUITING
Cervical Spine Health of Surgeons
NCT01932307 WITHDRAWN NA
Impact of Tai Chi in Cervical Myelopathy
NCT06876012 NOT_YET_RECRUITING NA
ERAS on Cervical Surgery
NCT04955496 COMPLETED