NCT05001893

Clinical Safety and Efficacy of S53P4 Bioactive Glass Putty in Spinal Fusion Surgery

Clinical Safety and Efficacy of S53P4 Bioactive Glass Putty in Spinal Fusion Surgery: Post Market Clinical Follow-up Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Bonalive Biomaterials Ltd · Industry
• Sex: —
• Age: —
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• Spine Fusion
• Spinal Deformity

Interventions

Type	Name	Description
DEVICE	S53P4 bioactive glass putty	Bonalive putty/putty MIS paste is a synthetic, bioactive, osteoconductive, osteostimulative bone void filler for filling, reconstruction, and regeneration of bone defects.

Timeline

• Start date: 2021-05-03
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-08-12
• Last updated: 2021-08-12

Locations

1 site across 1 country: Finland