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

NCT ID: NCT06736106

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-08-31

Brief Summary

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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

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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)

Conditions

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Spine Injuries and Disorders

Keywords

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spine surgery muscle strength physical fragility musculoskeletal system degenerative pathologies thoraco-lumbar spine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients

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

Group Type EXPERIMENTAL

screening

Intervention Type OTHER

Comprehensive screening of bone metabolic status and bone fragility in the largest cohort to date of patients with degenerative spinal diseases

Interventions

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screening

Comprehensive screening of bone metabolic status and bone fragility in the largest cohort to date of patients with degenerative spinal diseases

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera Universitaria Luigi Vanvitelli

UNKNOWN

Sponsor Role collaborator

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status RECRUITING

Azienda ospedaliera universitaria Luigi Vanvitelli

Napoli, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giovanni Barbanti Brodano, MD

Role: CONTACT

Phone: 6366971

Email: [email protected]

cristiana griffoni, phd

Role: CONTACT

Phone: 0516366

Email: [email protected]

Facility Contacts

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Cristiana Griffoni, PhD

Role: primary

Luigi aurelio nasto, MD

Role: primary

Other Identifiers

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PNRR-MCNT2-2023-12378098

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

OrthoSpine Fitness

Identifier Type: -

Identifier Source: org_study_id