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NCT06019572 Clinical Trial

Spine Trauma in the Elderly

Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06019572
Other study ID # 4-1712/2021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date June 15, 2023

Study information
Verified date August 2023
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 108
Est. completion date June 15, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All patients surgically treated for subaxial spine injuries between 2006 and 2018 Exclusion Criteria: - Missing records

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Sweden Karolinska University Hospital Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative complications medical or surgical complications 30-day postoperative period
Primary Mortality death End of the study period (or end of data collection)
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