NCT06019572

Brief Summary

Our study aims at investigating short and long-term outcomes following surgery for subaxial spine injuries in the elderly (octogenarian) population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

August 25, 2023

Last Update Submit

August 25, 2023

Conditions

Spine InjuryTraumaSurgery

Outcome Measures

Primary Outcomes (2)

  • Postoperative complications

    medical or surgical complications

    30-day postoperative period

  • Mortality

    death

    End of the study period (or end of data collection)

Study Arms (2)

Younger cohort (<80 years)

Procedure: Spine decompression and fixation surgery

octogenarians (≥80 years)

Procedure: Spine decompression and fixation surgery

Interventions

Spine decompression and fixation surgeryPROCEDURE

Surgery is performed by either an anterior or posterior approach. Anterior approach is performed with either discectomy or corpectomy accompanied fusion, while the posterior approach consist in a bilateral laminectomy accompanied by fusion.

Younger cohort (<80 years)octogenarians (≥80 years)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study hospital is a publicly funded tertiary care center serving a region of approximately 2.3 million inhabitants and the region's only level 1 trauma center. Patients were identified through the surgical management software Orbit (Evry Healthcare Systems, Solna, Sweden).

You may qualify if:

  • All patients surgically treated for subaxial spine injuries between 2006 and 2018

You may not qualify if:

  • Missing records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Spinal InjuriesWounds and Injuries

Interventions

Laminectomy

Condition Hierarchy (Ancestors)

Back Injuries

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresTherapeuticsDecompression, SurgicalSurgical Procedures, OperativeNeurosurgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 25, 2023

First Posted

August 31, 2023

Study Start

April 1, 2023

Primary Completion

June 1, 2023

Study Completion

June 15, 2023

Last Updated

August 31, 2023

Record last verified: 2023-08

Locations

SE(1)