Symptom Prevalence and Severity in Lumbar Spine Surgery With and Without Dura Rupture
Do Lumbar Spine Surgery Patients With Dura Rupture Differ in Symptom Prevalence and Severity From Other Lumbar Spine Surgery Patients in the Early Postoperative Phase
1 other identifier
observational
175
1 country
1
Brief Summary
The primary purpose of this study is to assess whether lumbar spine surgery patients with dura rupture differ in symptom prevalence and severity from other lumbar spine surgery patients in the early postoperative phase. This is in order to develop a symptom-specific mobilization algorithm (DURAMOB) that can be used to assess whether patients with dura rupture safe can be mobilized earlier after lumbar back surgery to prevent bed rest complications
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2021
CompletedFirst Submitted
Initial submission to the registry
March 9, 2021
CompletedFirst Posted
Study publicly available on registry
March 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMay 11, 2022
May 1, 2022
1.8 years
March 9, 2021
May 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Dura rupture symptom severity
To asses whether symptoms or compound of symptoms differ in patients with or without dura rupture in stand up up position 6 and 24 hours after lumbar surgery
9 month
Eligibility Criteria
Patients undergoing lumbar surgery with and without peroperative accidential dural lesion
You may qualify if:
- Lumbar surgery patients age \>18 years
You may not qualify if:
- Trauma surgery Cancer surgery lumbar fusion surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshospitalet, Glostrup
Glostrup Municipality, 2600, Denmark
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- RN, Cand Scient San stud
Study Record Dates
First Submitted
March 9, 2021
First Posted
March 11, 2021
Study Start
March 1, 2021
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
May 11, 2022
Record last verified: 2022-05