Identifying Health Markers to Reduce Complications in Spine Surgery
ORTHOSPINE FITNESS: Which Markers of Musculoskeletal Health Can Explain Complications in Spinal Surgery?
NA · Istituto Ortopedico Rizzoli · NCT06736106
This study is trying to find out if certain health markers can help predict and reduce complications for people having spine surgery for degenerative conditions.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli (other) |
| Locations | 2 sites (Bologna and 1 other locations) |
| Trial ID | NCT06736106 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate various markers of musculoskeletal health to understand their role in complications arising from spinal surgery for degenerative conditions. It involves a multicenter approach, utilizing advanced imaging techniques and assessments of physical fragility, muscle strength, and nutritional status in patients undergoing thoraco-lumbar spine surgery. The goal is to establish a comprehensive preoperative screening process that can enhance surgical decision-making and potentially reduce adverse outcomes. By identifying significant health markers, the study seeks to facilitate tailored preoperative interventions for better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with degenerative spinal conditions requiring surgical intervention.
Not a fit: Patients with tumors, infections in the spinal column, or those without surgical indications for their degenerative spine conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing spinal surgery.
How similar studies have performed: While the approach of using comprehensive musculoskeletal health markers is innovative, similar studies have shown promise in improving surgical outcomes in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bologna and 1 other locations
- Istituto Ortopedico Rizzoli — Bologna, Italy (RECRUITING)
- Azienda ospedaliera universitaria Luigi Vanvitelli — Naples, Italy (RECRUITING)
Study contacts
- Study coordinator: Giovanni Barbanti Brodano, MD
- Email: giovanni.barbantibrodano@ior.it
- Phone: 6366971
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Spine Injuries and Disorders, spine surgery, muscle strength, physical fragility, musculoskeletal system, degenerative pathologies, thoraco-lumbar spine