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Clinical Trials in Italy / NCT06736106
Recruiting Not applicable

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

NCT06736106 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Ortopedico Rizzoli
Phase
Not applicable
Started
2024-09-01
Last updated
2025-12-26

Condition(s) studied

Spine Injuries and Disorders

Investigational drug(s) / intervention(s)

screening

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • radiological images — at baseline (day 0)
    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
  • biological samples — at baseline (day 0), after 6 months, after 12 months
    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
  • pain — at baseline (day 0), after 12 months
    Pre-operative baseline assessment of pain level will be performed by self-administering validated questionnaires with the visual analogue scale (0-10)
  • Quality of life — at baseline (day 0), after 6 months, after 12 months
    the quality of life of the patients will be tracked by questionnairs
  • nutritional informations — since day 1 to day 14
    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.

Trial sites (2)

FacilityCityRegionStatus
Istituto Ortopedico Rizzoli Bologna Italy Recruiting
Azienda ospedaliera universitaria Luigi Vanvitelli Naples Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06736106 on ClinicalTrials.gov ↗ ← All trials in Italy