Status:
COMPLETED
Use of the Bone Substitute SintLife® in Vertebral Arthrodesis Procedures. A Pilot Study.
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Spinal Fusion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This pilot study is to evaluate the potential effectiveness of bone substitute SintLife within the spinal surgery in spinal stabilization applications for degenerative diseases. In particular, the in...
Detailed Description
1. INTRODUCTION AND RATIONALE The vertebral arthrodesis is one of the surgical procedures most used for the treatment of deformities, trauma and degenerative diseases with instability of the spine (Ra...
Eligibility Criteria
Inclusion
- Patients who have provided consent to the processing of personal data;
- Patients over the age of 18;
- Patients who require posterolateral fusion of lumbosacral tract (L1- S1);
- Patients suffering from traumatic and degenerative diseases of the spine, such as lumbar stenosis, spondylolysis and spondylolisthesis, degenerative disc disease;
- Patients who agree to participate in the program of visits required by the Protocol.
Exclusion
- Patients affected by:
- systemic or localized infection
- inflammatory or autoimmune disease
- hypercalcemia
- coagulation disorders
- metabolic disorders
- insulin dependent diabetes
- alterations or complications of thyroid function
- allergy to calcium phosphate
- declared allergies to medications and / or medical device
- tumor diseases and / or infectious diseases of the spine
- active neoplasia
- Patients who abuse of alcohol or drugs
- Patients in the alleged pregnancy or confirmed
- Patients on medication that causes abnormal bone regeneration (eg chemotherapy)
- Already operated patients (revision surgery)
Key Trial Info
Start Date :
March 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03407560
Start Date
March 31 2017
End Date
March 31 2021
Last Update
May 11 2023
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136