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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Spine Injuries and Disorders
• Intervention / Treatment: Other: screening

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)

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cristiana Griffoni, PhD; Phone Number: 130 0516366; Email: cristiana.griffoni@ior.it
• Study Contact Backup: Name: Giovanni Barbanti Brodano, MD; Phone Number: 051 6366971; Email: giovanni.barbantibrodano@ior.it

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Recruiting
    • Istituto Ortopedico Rizzoli
    • Contact: Cristiana Griffoni, PhD; Phone Number: +39-0516366971; Email: cgriffoni@hotmail.com
    • Principal Investigator: luigi aurelio nasto, md
  • Napoli, Italy, 20138
    • Recruiting
    • Azienda Ospedaliera Universitaria Luigi Vanvitelli
    • Contact: Luigi aurelio nasto, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients; patients with degenerative pathology of the thoraco-lumbar-sacral spine	Other: screening; Comprehensive screening of bone metabolic status and bone fragility in the largest cohort to date of patients with degenerative spinal diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiological images	constructed mechanical models from HR-pQCT data to quantify mechanical stiffness and bone strength at peripheral sites, which have already been shown to be effective predictors of fractures independent of DXA, and attempted their association with adverse events monitored during the follow-up	at baseline (day 0)
biological samples	The biopsies will be analyzed for analyzes at the level of secreted proteins (secretome) and gene expression. The bone harvest will be waste material obtained from the laminectomy, while the muscle harvest will be carried out in very small quantities from the posterior paravertebral muscles	at baseline (day 0), after 6 months, after 12 months
pain	Pre-operative baseline assessment of pain level will be performed by self-administering validated questionnaires with the visual analogue scale (0-10)	at baseline (day 0), after 12 months
Quality of life	the quality of life of the patients will be tracked by questionnairs	at baseline (day 0), after 6 months, after 12 months
nutritional informations	administration of a questionnaire to patients food frequency (Food Frequency Questionnaire - FFQ), which is an accurate measurement of nutrient intake within a 14-day period, using a diary food.	since day 1 to day 14

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Collaborators: Azienda Ospedaliera Universitaria Luigi Vanvitelli

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 12, 2024
• First Posted (Actual): December 16, 2024

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: muscle strength; spine surgery; musculoskeletal system; physical fragility; degenerative pathologies; thoraco-lumbar spine
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Diagnostic Services; Health Surveys; Surveys and Questionnaires; Public Health Practice; Mass Screening
• Other Study ID Numbers: OrthoSpine Fitness; PNRR-MCNT2-2023-12378098 (Other Grant/Funding Number: Ministero della Salute.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No