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NCT Number: NCT06873074

A Retrospective Cohort Study About Surgical Efficacy for 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.

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Key information

Conditions

Ankylosing Spondylitis (AS) Ankylosis Arthritis Axial Spondyloarthritis Back Injuries Bone Diseases Fractures, Bone Joint Diseases Joint Dislocations Musculoskeletal Diseases Spinal Diseases Spinal Fractures Spinal Injuries Spine Fracture Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

anterior long segment cervical fixation

Procedure

posterior long segment cervical fixation

Procedure

combined anterior and posterior fixation

Procedure

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Zhou Fang

Other

Collaborators

  • Luohe Central Hospital

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2024
Study completion
2024
First posted
Mar 12, 2025
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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