NCT07847320

Brief Summary

Retrospective observational

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

Same day

First QC Date

September 23, 2026

Last Update Submit

September 23, 2026

Conditions

Keywords

B3 fracturesspine fractures

Outcome Measures

Primary Outcomes (1)

  • Complications

    Clavien-Dindo classification for complications

    12 months

Secondary Outcomes (1)

  • Hardware related complications

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with ankylozing spondylitis and B3 spine fractures

You may qualify if:

  • Patients were eligible if they were aged 18 years or older
  • Had a documented diagnosis of ankylosing spondylitis
  • Had an imaging-confirmed AO Spine B3 fracture,
  • Underwent posterior instrumented stabilization.

You may not qualify if:

  • Patients managed non-operatively
  • Patients with spondylodiscitis, primary or metastatic neoplasia, or congenital spinal anomalies were excluded.
  • Patients with insufficient data for the predefined variables or without follow-up to the primary endpoint were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Kohler FC, Schenk P, Bechstedt-Schimske M, Ullrich BW, Klauke F, Hofmann GO, Mendel T. Open versus minimally invasive fixation of thoracic and lumbar spine fractures in patients with ankylosing spinal diseases. Eur J Trauma Emerg Surg. 2022 Jun;48(3):2297-2307. doi: 10.1007/s00068-021-01756-3. Epub 2021 Aug 6.

    PMID: 34357408BACKGROUND
  • Westerveld LA, van Bemmel JC, Dhert WJ, Oner FC, Verlaan JJ. Clinical outcome after traumatic spinal fractures in patients with ankylosing spinal disorders compared with control patients. Spine J. 2014 May 1;14(5):729-40. doi: 10.1016/j.spinee.2013.06.038. Epub 2013 Aug 27.

    PMID: 23992936BACKGROUND

MeSH Terms

Conditions

Spinal FracturesOsteoporosisSpondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Spinal InjuriesBack InjuriesWounds and InjuriesFractures, BoneBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesAxial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesAnkylosisJoint DiseasesArthritis

Central Study Contacts

Edgar Santos, PD. Dr. med

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2026

First Posted

September 29, 2026

Study Start

September 20, 2026

Primary Completion

September 20, 2026

Study Completion

September 20, 2026

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share