A Retrospective Cohort Study About Surgical Efficacy for Lower Cervical Fractures in Ankylosing Spondylitis

March 7, 2025 updated by: Zhou Fang

Comparison of the Efficacy of Anterior and Posterior Long-segment Cervical Fixation for the Treatment of Lower Cervical Fractures in Ankylosing Spondylitis

The purpose of this retrospective cohort study was to observe and compare the efficacy of anterior cervical long segment fixation, posterior long segment fixation, and combined anterior and posterior fixation for the treatment of cervical vertebral fracture-dislocations in the lower cervical spine in ankylosing spondylitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was a retrospective cohort study. Patients operated for fracture-dislocation of the lower cervical vertebrae in ankylosing spondylitis in our hospital from 01/2014 to 01/2024 were retrospectively included as study subjects. Prior to the start of the study, an application will be made for approval through the hospital ethical committee, and the Declaration of Helsinki will be observed during the course of the study. The patients were divided into an anterior group (anterior long-segment cervical fixation), a posterior group (posterior long-segment cervical fixation), and a combined group (combined anterior and posterior fixation) according to the surgical access. The operation time, bleeding, complication occurrence, fracture healing and changes in neurological function of the three groups were compared. In this study, Frankel grading before and after surgery was used as the primary observation index, and operation time, intraoperative bleeding, occurrence of complications, and cervical fracture healing were used as the secondary observation index. SPSS 26.0 (IBM, New York, NY, USA) was applied for statistical analysis in this study.

Study Type

Observational

Enrollment (Actual)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A multicenter-center retrospective cohort analysis of patients with ankylosing spondylitis (AS)-associated lower cervical fractures (C3-C7) treated between 2014 and 2023.

Description

Inclusion criteria:

Meet the diagnostic criteria for ankylosing spondylitis, imaging showed that cervical ankylosing and fracture dislocation of the lower cervical vertebrae (cervical 3~7); Age 18~80 years old; undergo anterior, posterior or combined access internal fixation surgery and the fixation segment is ≥4 segments.

Exclusion criteria:

Systemic or local infection; Previous history of cervical vertebrae surgery; Postoperative loss of follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
anterior group
anterior long segment cervical fixation
Procedure: anterior long segment cervical fixation
posterior group
posterior long segment cervical fixation
Procedure: posterior long segment cervical fixation
combined group
combined anterior and posterior fixation
Procedure: combined anterior and posterior fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications
Time Frame: 1, 3, 6, and 12 months after the surgery at the final follow-up

Categorized by the Clavien-Dindo classification system. Documented events include:

Intraoperative: Dural tear, vertebral artery injury, nerve root injury.

Postoperative (within 30 days): Surgical site infection, implant failure (screw loosening/breakage), cerebrospinal fluid leakage, dysphagia (anterior approach group), adjacent segment degeneration.
1, 3, 6, and 12 months after the surgery at the final follow-up
Radiographic Union Rate Assessed by X-ray and CT Criteria
Time Frame: 1, 2, 3, 6, and 12 months after the surgery at the final follow-up

X-ray union: Fracture line blurring with callus formation ≥50% of fracture area on anteroposterior/lateral views.

CT union: Complete fracture line disappearance with continuous callus bridging on thin-slice (≤1 mm) CT reconstructions.
1, 2, 3, 6, and 12 months after the surgery at the final follow-up
Frankel Grade Improvement Rate and Neurological Recovery Index
Time Frame: 1, 3, 6, and 12 months after the surgery at the final follow-up

Assessment tool: Frankel Spinal Cord Injury Scale (A: complete paralysis; B: sensory preservation only; C: non-functional motor preservation; D: functional motor preservation; E: normal function).

Improvement rate: Defined as ≥1-grade improvement from baseline, reported as frequency (percentage).

Recovery index: Calculated by assigning numerical values (A=1 to E=5), with differences between preoperative and final grades expressed as mean ± SD.

Severe injury recovery: Proportion of patients with preoperative Frankel B/C grades achieving D/E grades postoperatively.
1, 3, 6, and 12 months after the surgery at the final follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: immediately after surgery
Defined as the duration from skin incision to wound closure (minutes). Data will be presented as mean ± standard deviation (SD) and compared among anterior, posterior, and combined approach groups.
immediately after surgery
Intraoperative blood loss:
Time Frame: immediately after surgery
Calculated using suction drainage volume combined with gauze weight measurement (1 g ≈ 1 mL). Reported as median (range) and mean ± SD.
immediately after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhou Fang

Collaborators

Luohe Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PekingUTH LXZ-AS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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