Clinical trial NCT06873074: A Retrospective Cohort Study About Surgical Efficacy for Lower Cervical Fractures in Ankylosing Spondylitis
Official title: Comparison of the Efficacy of Anterior and Posterior Long-segment Cervical Fixation for the Treatment of Lower Cervical Fractures in Ankylosing Spondylitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis (AS)
Spine Fracture
Keywords: Ankylosing Spondylitis
Cervical fracture and dislocation
anterior internal fixation and fusion
posterior internal fixation and fusion
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Luohe Central Hospital
First posted: 2025-03-12
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: complications
timeFrame: 1, 3, 6, and 12 months after the surgery at the final follow-up
measure: Radiographic Union Rate Assessed by X-ray and CT Criteria
timeFrame: 1, 2, 3, 6, and 12 months after the surgery at the final follow-up
measure: Frankel Grade Improvement Rate and Neurological Recovery Index
timeFrame: 1, 3, 6, and 12 months after the surgery at the final follow-up
Secondary outcomes:
measure: Operative time
timeFrame: immediately after surgery
measure: Intraoperative blood loss:
timeFrame: immediately after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: