Ankylosing Spondylitis (AS)NCT06873074
A Retrospective Cohort Study About Surgical Efficacy for Lower Cervical Fractures in Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis (AS) and Spine Fracture, run by Zhou Fang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ankylosing Spondylitis (AS), Spine Fracture
- What is being tested?
- anterior long segment cervical fixation, posterior long segment cervical fixation and combined anterior and posterior fixation
- Type of treatment
- Surgery or procedure
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2014to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Systemic or local infection; Previous history of cervical vertebrae surgery; Postoperative loss of follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: 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.
Read the 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.
- Conditions
- Ankylosing Spondylitis (AS), Spine Fracture
- Being tested
- anterior long segment cervical fixation, posterior long segment cervical fixation, combined anterior and posterior fixation
- Keywords
- Ankylosing Spondylitis, Cervical fracture and dislocation, anterior internal fixation and fusion, posterior internal fixation and fusion
- Medical subject headings
- Spondylitis, Ankylosing, Spinal Fractures, Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anterior long segment cervical fixationProcedure or surgery
posterior long segment cervical fixationProcedure or surgery
combined anterior and posterior fixationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| anterior group | anterior long segment cervical fixation Receives: Procedure: anterior long segment cervical fixation | |
| posterior group | posterior long segment cervical fixation Receives: Procedure: posterior long segment cervical fixation | |
| combined group | combined anterior and posterior fixation Receives: Procedure: combined anterior and posterior fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1, 3, 6, and 12 months after the surgery at the final follow-up
Secondary outcomes (2)
Operative time
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.
Measured: immediately after surgery
Intraoperative blood loss:
Calculated using suction drainage volume combined with gauze weight measurement (1 g ≈ 1 mL). Reported as median (range) and mean ± SD.
Measured: immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start1 Jan 2014
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing Spondylitis (AS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhou Fang
- Sponsor type
- University, hospital or other
- Collaborators
- Luohe Central Hospital
- Responsible party
- Sponsor-investigator, Zhou Fang, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06873074
- Sponsor's protocol ID
- PekingUTH LXZ-AS
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Anterior and Posterior Long-segment Cervical Fixation for the Treatment of Lower Cervical Fractures in Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT06873074
- Acronym / sponsor ID
- PekingUTH LXZ-AS
- Conditions
- Ankylosing Spondylitis (AS), Spine Fracture
- Keywords
- Ankylosing Spondylitis, Cervical fracture and dislocation, anterior internal fixation and fusion, posterior internal fixation and fusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Zhou FangUniversity, hospital or other
- Collaborators
- Luohe Central Hospital
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| anterior group | – | Procedure: anterior long segment cervical fixationanterior long segment cervical fixation |
| posterior group | – | Procedure: posterior long segment cervical fixationposterior long segment cervical fixation |
| combined group | – | Procedure: combined anterior and posterior fixationcombined anterior and posterior fixation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Systemic or local infection; Previous history of cervical vertebrae surgery; Postoperative loss of follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anterior long segment cervical fixation | Procedure or surgery | anterior group |
| posterior long segment cervical fixation | Procedure or surgery | posterior group |
| combined anterior and posterior fixation | Procedure or surgery | combined group |
Primary outcome
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.
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.
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.
2 secondary outcomes
Operative time
Time frame: immediately after surgery
Intraoperative blood loss:
Time frame: immediately after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis (AS) and Spine Fracture, run by Zhou Fang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complications (time frame: 1, 3, 6, and 12 months after the surgery at the final follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.