Actively Recruiting
ORTHOSPINE FITNESS: Which Markers of Musculoskeletal Health Can Explain Complications in Spinal Surgery?
Led by Istituto Ortopedico Rizzoli · Updated on 2025-12-26
200
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Istituto Ortopedico Rizzoli
Lead Sponsor
A
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating markers of musculoskeletal health to understand complications in spinal surgery for patients with degenerative diseases of the thoraco-lumbo-sacral spine. This multicenter study, funded by the European Union and the Ministry of Health, aims to address the significant problem of surgical complications, which occur in 7 to 20% of cases and impact both patients and healthcare systems. The goal is to improve surgical decisions and reduce adverse events by identifying important health markers. The study involves comprehensive preoperative screening combining advanced imaging techniques, including HRpQCT scans to assess bone microstructure and computational analysis of bone strength. It also evaluates physical fragility by measuring muscle strength and balance, along with cellular and molecular tests of bone and muscle interaction, and nutritional assessments. These evaluations will help define surgical suitability and guide patient-specific interventions such as nutritional support or physical preparation before surgery. Participants will undergo assessments including radiological imaging, collection of biological samples at baseline, six months, and twelve months, and evaluations of pain, quality of life, and nutritional status over two weeks from the start. The study tracks these measures to understand their relationship with post-surgical complications. Participation lasts at least 12 months, with follow-up visits to monitor outcomes and support surgical decision-making.
CONDITIONS
Brief Title
Which Markers of Musculoskeletal Health Can Explain Complications in Spinal Surgery?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63 18 years
- Diagnosis of degenerative pathology of the spinal column of the thoraco-lumbo-sacral tract
- Candidates for surgical treatment for the above pathology during the study period
- Willingness to participate and sign informed consent
You will not qualify if you...
- Presence of tumors or infections in the spinal column
- Degenerative pathology of the spine without surgical indication
- Degenerative pathology of the spinal column at the cervical level
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo comprehensive preoperative screening of bone health and musculoskeletal status, including imaging, biological samples, and assessments of physical fragility and nutritional status.
1 baseline visit (in-person)
Duration - 12 months
Participants are monitored through biological samples, pain assessment, and quality of life evaluations over 12 months following the baseline assessment.
Visits at baseline, 6 months, and 12 months with nutritional information collected during the first 14 days
Trial Site Locations
Total: 2 locations
1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Actively Recruiting
2
Azienda ospedaliera universitaria Luigi Vanvitelli
Naples, Italy, 20138
Actively Recruiting
Research Team
G
Giovanni Barbanti Brodano, MD
C
cristiana griffoni, phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Frequently Asked Questions
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