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

Completed

• Conditions: Ankylosing Spondylitis (AS); Spine Fracture

• Registration Number: NCT06873074
• Lead Sponsor: Zhou Fang

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.

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 Timeline

• Study Start: 2014-01-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-03
• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-07
• Last Update Submitted: 2025-03-07
• Study First Posted: 2025-03-12
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
complications	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.
Radiographic Union Rate Assessed by X-ray and CT Criteria	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.
Frankel Grade Improvement Rate and Neurological Recovery Index	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.

Secondary Outcome Measures

Name	Time	Method
Operative time	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.
Intraoperative blood loss:	immediately after surgery	Calculated using suction drainage volume combined with gauze weight measurement (1 g ≈ 1 mL). Reported as median (range) and mean ± SD.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China