Which Markers of Musculoskeletal Health Can Explain Complications in Spinal Surgery? (NCT06736106) | Clinical Trial Compass
RecruitingNot Applicable
Which Markers of Musculoskeletal Health Can Explain Complications in Spinal Surgery?
Italy200 participantsStarted 2024-09-01
Plain-language summary
The present study is related to the project "ORTHOSPINE FITNESS: WHICH MARKERS OF MUSCULOSKELETAL HEALTH CAN EXPLAIN COMPLICATIONS IN SPINE SURGERY?", winner of the Ministry of Health Call, financed by the European Union, "M6/C2\_CALL 2023", Project Code " PNRR- MCNT2-2023-12378098", Call section "Non-chronic chronic diseases transmissible diseases (MCnT2) with a high impact on health systems".
Complications of spinal surgery still represent a significant and unsolved problem. Their incidence is between 7 and 20%, with a high percentage of mechanical complications observed in patients operated on for degenerative pathologies. Readmissions, re-operations and subsequent rehabilitation treatments have a heavy impact on patients and the entire healthcare system.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \>= 18 years;
* diagnosis of degenerative pathology of the spinal column of the thoraco-lumbo-sacral tract;
* patients candidates for surgical treatment for the aforementioned pathology during the study period;
* willingness to participate in the study and sign the specific informed consent
Exclusion Criteria:
* presence of tumors or infections in the spinal column;
* presence of degenerative pathology of the spine without surgical indication;
* presence of degenerative pathology of the spinal column at the cervical level.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
radiological images
Timeframe: at baseline (day 0)
2
biological samples
Timeframe: at baseline (day 0), after 6 months, after 12 months
3
pain
Timeframe: at baseline (day 0), after 12 months
4
Quality of life
Timeframe: at baseline (day 0), after 6 months, after 12 months