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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituto Ortopedico Rizzoli

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • screening

    Other intervention

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: PatientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
at baseline (day 0)
2

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

Time frame
at baseline (day 0), after 6 months, after 12 months
3

pain

Pre-operative baseline assessment of pain level will be performed by self-administering validated questionnaires with the visual analogue scale (0-10)

Time frame
at baseline (day 0), after 12 months
4

Quality of life

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Ortopedico Rizzoli

Lead sponsor

Azienda Ospedaliera Universitaria Luigi Vanvitelli

Collaborator