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

NCT06873074 | Completed

• 1 other identifier: PekingUTH LXZ-AS
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ankylosing Spondylitis (AS); Spine Fracture

Keywords

Ankylosing Spondylitis; Cervical fracture and dislocation; anterior internal fixation and fusion; posterior internal fixation and fusion

Outcome Measures

Primary Outcomes (3)

• complications

  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

  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

  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 Outcomes (2)

• Operative time

  immediately after surgery

• Intraoperative blood loss:

  immediately after surgery

Study Arms (3)

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

Interventions

anterior long segment cervical fixation PROCEDURE

anterior group

posterior long segment cervical fixation PROCEDURE

posterior group

combined anterior and posterior fixation PROCEDURE

combined group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zhou Fang: lead
• Luohe Central Hospital: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing; Spinal Fractures; Joint Dislocations

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Orthopaedics

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 12, 2025
• Study Start: January 1, 2014
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)