Clinical Safety and Efficacy of S53P4 Bioactive Glass Putty in Spinal Fusion Surgery
Launched by BONALIVE BIOMATERIALS LTD · Aug 11, 2021
Trial Information
Current as of May 30, 2025
Unknown status
Keywords
ClinConnect Summary
In the first stage of the investigation, the clinical safety and efficacy of BonAlive® putty are assessed in a retrospective case-series, and the observations are compared to the existing literature. Thereafter, a retrospective case-controlled study will be created to compare the use of a mixture of BonAlive® putty and AB to AB alone for clinical safety and efficacy. The cases will be matched up with the controls by gender, age, smoking behavior, the number of operated levels and the site of operated levels as far as possible. The chosen surgical technique will be the most commonly used.
Gender
Eligibility criteria
- Inclusion Criteria:
- • 1. Performed spine fusion operation
- • 2. BonAlive® putty used in the operation
- Exclusion Criteria:
- • 1. Age under 18
- • 2. Use of other synthetic bone graft substitute or expander materials than BonAlive® putty in the operation
- • 3. Less time than two years since the index operation and no CT-proof of intended bony fusion
About Bonalive Biomaterials Ltd
Bonalive Biomaterials Ltd. is a pioneering biotechnology company specializing in the development of innovative bone regeneration solutions. Focused on advancing the field of regenerative medicine, Bonalive's proprietary biomaterials are designed to enhance bone healing and regeneration in various orthopedic and dental applications. The company is committed to clinical excellence and adheres to the highest standards of research and development, aiming to improve patient outcomes through cutting-edge technology and collaboration with healthcare professionals. With a robust pipeline of products and ongoing clinical trials, Bonalive is dedicated to transforming the landscape of bone repair and regeneration.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Turku, , Finland
Patients applied
Trial Officials
Ilkka Saarenpää, MD, PhD
Principal Investigator
Turku University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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