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Clinical Safety and Efficacy of S53P4 Bioactive Glass Putty in Spinal Fusion Surgery
A retrospective, single-tertiary centre observational study. The study population consists mainly of patients with instrumented posterolateral spine fusion operated at the Department of Neurosurgery or at the Department of Orthopaedics and Traumatology in the Turku University Hospital. Also, patients with non-instrumented posterolateral spine fusion, interbody spine fusion, and a combination of posterolateral and interbody spine fusion are included. The approximate number of the above-mentioned operations with BonAlive® putty is 400 - 500 between September 2013 and April 2021. In the operations, the BonAlive® putty was used either alone, together with autologous bone (AB) chips, with milled allogenous bone chips, with demineralized bone matrix (DBM), with other synthetic bone grafts, or with a combination of the above-mentioned.
Details
| Lead sponsor | Bonalive Biomaterials Ltd |
|---|---|
| Status | UNKNOWN |
| Enrolment | 500 |
| Start date | Mon May 03 2021 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Sat Dec 31 2022 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Spine Fusion
- Spinal Deformity
Interventions
- S53P4 bioactive glass putty
Countries
Finland