Spine InjuryNCT06019572
Spine Trauma in the Elderly
An observational study of Spine Injury and Trauma, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Our study aims at investigating short and long-term outcomes following surgery for subaxial spine injuries in the elderly (octogenarian) population. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spine Injury, Trauma, Surgery
- What is being tested?
- Spine decompression and fixation surgery
- Type of treatment
- Surgery or procedure
- How many people
- 108 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2023to 15 Jun 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- All patients surgically treated for subaxial spine injuries between 2006 and 2018
Who cannot join
- Missing records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Outcomes After Surgery for Subaxial Cervical Spine Injuries in Octogenarians, a Matched Controlled Analysis
Our study aims at investigating short and long-term outcomes following surgery for subaxial spine injuries in the elderly (octogenarian) population.
- Conditions
- Spine Injury, Trauma, Surgery
- Being tested
- Spine decompression and fixation surgery
- Medical subject headings
- Spinal Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine decompression and fixation surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Younger cohort (<80 years) | Not described Receives: Procedure: Spine decompression and fixation surgery | |
| octogenarians (≥80 years) | Not described Receives: Procedure: Spine decompression and fixation surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
medical or surgical complications
Measured: 30-day postoperative period
Mortality
death
Measured: End of the study period (or end of data collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Apr 2023
- Primary completion1 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine InjuryStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrian Elmi Terander, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019572
- Sponsor's protocol ID
- 4-1712/2021
- Status last verified
- Aug 2023
- First submitted
- 25 Aug 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes After Surgery for Subaxial Cervical Spine Injuries in Octogenarians, a Matched Controlled Analysis
- ClinicalTrials.gov ID
- NCT06019572
- Acronym / sponsor ID
- 4-1712/2021
- Conditions
- Spine Injury, Trauma, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 31 Aug 2023 (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.
Our study aims at investigating short and long-term outcomes following surgery for subaxial spine injuries in the elderly (octogenarian) population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Younger cohort (<80 years) | – | Procedure: Spine decompression and fixation surgery |
| octogenarians (≥80 years) | – | Procedure: Spine decompression and fixation surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- All patients surgically treated for subaxial spine injuries between 2006 and 2018
Key exclusion criteria (1 listed)
- Missing records
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 |
|---|---|---|
| Spine decompression and fixation surgerySurgery 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. | Procedure or surgery | Younger cohort (<80 years), octogenarians (≥80 years) |
Primary outcome
Postoperative complications
Time frame: 30-day postoperative period
medical or surgical complications
Mortality
Time frame: End of the study period (or end of data collection)
death
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 31 Aug 2023.
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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 Spine Injury and Trauma, run by Karolinska Institutet at 1 site in Sweden.
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 31 Aug 2023. 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 Sweden. 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?
Postoperative complications (time frame: 30-day postoperative period). The study lists 2 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 31 Aug 2023.