Clinical trial NCT06736106: Which Markers of Musculoskeletal Health Can Explain Complications in Spinal Surgery?
Official title: ORTHOSPINE FITNESS: Which Markers of Musculoskeletal Health Can Explain Complications in Spinal Surgery?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spine Injuries and Disorders
Keywords: spine surgery
muscle strength
physical fragility
musculoskeletal system
degenerative pathologies
thoraco-lumbar spine
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera Universitaria Luigi Vanvitelli
First posted: 2024-12-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: The study proposed, financed through the "PNRR-MCNT2-2023-12378098" call, is a multicenter study on a large cohort of patients undergoing spinal surgery for degenerative pathologies of the thoraco-lumbar spine, which has as its general objective to establish a comprehensive preoperative screening of bone health and the musculoskeletal system, combining advanced imaging and modeling (HRpQCT images of bone microstructure at peripheral sites and related computational assessment of bone mechanical properties), assessment of physical fragility (including muscle strength and assessment of proprioception/fall risk), cellular and molecular analyzes of bone fitness and bone-muscle cross-talk, and assessment of nutritional status.

The results of the project will allow us to: (i) define a concept of "surgical suitability" to evaluate patients candidates for elective spinal surgery and possibly improve the surgical decision-making process (for example the choice of fixation and instrumentation); (ii) identify a minimum set of significant and independent markers to monitor in future interventional studies aimed at reducing the risk of adverse events in spinal surgery, (iii) allow patient-specific preoperative interventions (such as nutritional supplementation, physical pre-habilitation or administration of bone anabolic agents)

Eligibility criteria: 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.

Primary outcomes:
measure: radiological images
timeFrame: at baseline (day 0)
measure: biological samples
timeFrame: at baseline (day 0), after 6 months, after 12 months
measure: pain
timeFrame: at baseline (day 0), after 12 months
measure: Quality of life
timeFrame: at baseline (day 0), after 6 months, after 12 months
measure: nutritional informations
timeFrame: since day 1 to day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
city: Napoli
country: Italy
facility: Azienda ospedaliera universitaria Luigi Vanvitelli
Study officials:
References: