---
title: Correlation Between Parameters and Prognosis of Cervical Single Open-door Surgery
nct_id: NCT05767164
overall_status: RECRUITING
phase: NA
sponsor: Xijing Hospital
study_type: INTERVENTIONAL
primary_condition: Cervical Spinal Stenosis
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05767164.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05767164"
ct_last_update_post_date: 2025-04-09
last_seen_at: "2026-05-12T07:23:10.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Correlation Between Parameters and Prognosis of Cervical Single Open-door Surgery

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

**NCT ID:** [NCT05767164](https://clinicaltrials.gov/study/NCT05767164)

## Key Facts

- **Status:** RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 500
- **Lead Sponsor:** Xijing Hospital
- **Collaborators:** Xi'an Honghui Hospital, First Affiliated Hospital Xi'an Jiaotong University, Tang-Du Hospital
- **Conditions:** Cervical Spinal Stenosis
- **Start Date:** 2023-01-01
- **Completion Date:** 2025-12-31
- **CT.gov Last Update:** 2025-04-09

## 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

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 86 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Preoperative** (NO_INTERVENTION)
- **postoperative (3 months)** (EXPERIMENTAL)
- **postoperative (6 months)** (EXPERIMENTAL)
- **postoperative (1 year)** (EXPERIMENTAL)

## 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.

## Primary Outcomes

- **lamina open angle** _(time frame: 3 months after surgery)_ — The Angle of opening of the cervical unilateral lamina while cervical single open-door surgery
- **JOA score change** _(time frame: pre-operation,3 months after surgery, 1 year after surgery)_ — 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%.
- **NDI score change** _(time frame: pre-operation,3 months after surgery, 1 year after surgery)_ — 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.
- **VAS score change** _(time frame: pre-operation,3 months after surgery)_ — 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.

## Secondary Outcomes

- **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)_

## Locations (1)

- Xijing Hospital, Xi'an, Shannxi Province, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.xijing hospital|xi'an|shannxi province|china` — added _(2026-05-12)_

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