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

Bonalive Biomaterials

Status: Unknown

Conditions: Spine Fusion; Spinal Deformity

Treatments: Device: S53P4 bioactive glass putty

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05001893

103-CL01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

The use of a mixture of BonAlive® putty and autologous bone

Description:

A retrospective case-controlled study will be created to compare the use of a mixture of BonAlive® putty and autologous bone to autologous bone alone for clinical safety and efficacy.

Treatment:

Device: S53P4 bioactive glass putty