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NCT Number: NCT06736106

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.

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Key information

Conditions

Spine Injuries and Disorders Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico Rizzoli, Bologna, Italy

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Screening

Other

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

Primary outcomes

  1. radiological images

    Time frame: 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

  2. biological samples

    Time frame: 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

  3. pain

    Time frame: 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)

  4. Quality of life

    Time frame: at baseline (day 0), after 6 months, after 12 months

    the quality of life of the patients will be tracked by questionnairs

  5. nutritional informations

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Barbanti Brodano, MD

CONTACT

[email protected]

6366971 ext. 051

cristiana griffoni, phd

CONTACT

[email protected]

0516366 ext. 130

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Collaborators

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2024
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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