Spine Trauma in the Elderly

Sponsor

Karolinska Institutet (Other)

Overall Status

Completed

CT.gov ID

NCT06019572

Collaborator

(none)

108

Enrollment

Location

2.5

Actual Duration (Months)

43.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Spine Injury Trauma Surgery	Procedure: Spine decompression and fixation surgery

Study Design

Study Type:

Observational

Actual Enrollment :

108 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Long-term Outcomes After Surgery for Subaxial Cervical Spine Injuries in Octogenarians, a Matched Controlled Analysis

Actual Study Start Date :

Apr 1, 2023

Actual Primary Completion Date :

Jun 1, 2023

Actual Study Completion Date :

Jun 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Younger cohort (<80 years)	Procedure: Spine decompression and fixation surgery 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.
octogenarians (≥80 years)	Procedure: Spine decompression and fixation surgery 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.

Arm

Intervention/Treatment

Younger cohort (<80 years)

Procedure: Spine decompression and fixation surgery

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.

octogenarians (≥80 years)

Procedure: Spine decompression and fixation surgery

Outcome Measures

Primary Outcome Measures

Postoperative complications [30-day postoperative period]
medical or surgical complications
Mortality [End of the study period (or end of data collection)]
death

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Missing records

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska University Hospital	Stockholm		Sweden

Sponsors and Collaborators

Karolinska Institutet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Adrian Elmi Terander, Associate Professor, Karolinska Institutet

ClinicalTrials.gov Identifier:

NCT06019572

Other Study ID Numbers:

4-1712/2021

First Posted:

Aug 31, 2023

Last Update Posted:

Aug 31, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Spinal Injuries

Study Results

No Results Posted as of Aug 31, 2023