Study of Individualized, Precise and Standardized Cervical Open-door Surgery for Cervical Spinal Stenosis

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2025-12-31

Brief Summary

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To evaluate the safety and effectiveness of individualized, precise and standardized open-door posterior cervical surgery through a single-center, exploratory clinical study, so as to provide a more reliable basis for the treatment of cervical spinal stenosis.

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Detailed Description

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Conditions

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Cervical Spinal Stenosis Cervical Spinal Cord Injury Individuation Standardization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Centerpiece titanium plate

All surgical operations were performed by the same group of senior spine surgeons. The range of open door decompression involved C3 \~ C7. For convenient operation and more accurate statistics, the right side of the door axis and the left side of the door seam were selected for all operations. Centerpiece titanium plates were used for intraoperative fixation.

Group Type ACTIVE_COMPARATOR

Centerpiece titanium plate

Intervention Type PROCEDURE

All indexes were collected from the patients with Centerpiece titanium plate for internal fixation.

3D printed arch titanium plate

Before surgery, according to the imaging results, according to the effective imaging indicators screened in the early stage and the calculated door opening Angle formula, the door opening Angle of the patient's posterior cervical vertebra and the size of the fitted arch titanium plate were designed by mimics 10.0 software, and the titanium plate was printed using 3D printing technology. During the operation, the developed laminae opener was used to accurately control the door opening Angle and appropriate size titanium plate was installed for internal fixation. The standardized laminae door opening guide was used to complete the preparation of the door shaft side and door opening side of the lamina

Group Type EXPERIMENTAL

Centerpiece titanium plate

Intervention Type PROCEDURE

All indexes were collected from the patients with Centerpiece titanium plate for internal fixation.

Interventions

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Centerpiece titanium plate

All indexes were collected from the patients with Centerpiece titanium plate for internal fixation.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* The age of 28-85 years old; Through systematic clinical and imaging examination, patients diagnosed with C3-7 multilevel cervical spondylitis myelopathy or cervical spinal stenosis who need to undergo posterior cervical open-door surgery.
* No contraindications in preoperative routine tests and examinations.
* Informed consent of patients.

Exclusion Criteria

* Cervical radiculopathy
* Cervical kyphosis or instability
* Cervical spondylosis caused by trauma, tumor, tuberculosis and metabolic diseases
* Revision surgery or combined anterior-posterior surgery is required
* Serious neurological diseases affect the postoperative effect evaluation
* Mental illness cannot cooperate with follow-up
* Contraindications for MRI examination
* Patients themselves or their families do not agree to participate in the study
* Other situations that are not suitable for study participation.

Minimum Eligible Age

28 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No