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

NCT06736106 | Recruiting

• 2 other identifiers: OrthoSpine FitnessPNRR-MCNT2-2023-12378098
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Spine Injuries and Disorders

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Patients

EXPERIMENTAL

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

Other: screening

Interventions

screening OTHER

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

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead
• Azienda Ospedaliera Universitaria Luigi Vanvitelli: collaborator

Study Sites (2)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Azienda ospedaliera universitaria Luigi Vanvitelli

Naples, 20138, Italy

RECRUITING

MeSH Terms

Conditions

Disease

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Central Study Contacts

Giovanni Barbanti Brodano, MD

CONTACT

6366971; giovanni.barbantibrodano@ior.it

cristiana griffoni, phd

CONTACT

0516366; cristiana.griffoni@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 16, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

IT (2)