Which Markers of Musculoskeletal Health Can Explain Complications in Spinal Surgery?

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Spine Injuries and Disorders

Treatments: Other: screening

Study type: Interventional

Funder types: Other

Identifiers

NCT06736106

PNRR-MCNT2-2023-12378098 (Other Grant/Funding Number)

OrthoSpine Fitness

Details and patient eligibility

About

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.

Full 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)

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Patients

Experimental group

Description:

patients with degenerative pathology of the thoraco-lumbar-sacral spine

Treatment:

Other: screening