Clinical trial NCT05001893: Clinical Safety and Efficacy of S53P4 Bioactive Glass Putty in Spinal Fusion Surgery
Official title: Clinical Safety and Efficacy of S53P4 Bioactive Glass Putty in Spinal Fusion Surgery: Post Market Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spine Fusion
Spinal Deformity
Keywords: S53P4
Bonalive
Bioactive glass putty
Spine fusion
Lumbar spine fusion
Lead sponsor: Bonalive Biomaterials Ltd
Sponsor class: INDUSTRY
Collaborators: name: Turku University Hospital
First posted: 2021-08-12
Enrollment: 500
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

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

Primary outcomes:
measure: To demonstrate the clinical efficacy of BonAlive® (S53P4 bioactive glass) putty in spine fusion operations when used alone and together with autologous bone.
timeFrame: 24 months
measure: Clinical outcomes are for pain VAS:
timeFrame: 24 months
measure: EQ-5D cost effectiviness questionnaires.
timeFrame: 24 months
measure: ODI: (Oswestry Low Back Pain Disability Questionnaire).
timeFrame: 24 months
measure: 15 D questionnaire The 15D is a generic, comprehensive (15-dimensional), self-administered instrument for measuring HRQoL among adults.
timeFrame: 24 months
Secondary outcomes:
measure: To demonstrate that the clinical efficacy of BonAlive® putty used together with autologous bone in spine fusion operations is not inferior to the clinical efficacy of autologous bone used alone.
timeFrame: 24 months
measure: To demonstrate that the clinical use of BonAlive® putty does not cause excess infections or other complications subsequent to spine fusion operations compared to the reported amounts in the literature without the use of BonAlive® putty.
timeFrame: 24 months
Other outcomes:
measure: • To demonstrate that the clinical use of BonAlive® putty does not cause excess infections or other complications subsequent to spine fusion operations compared to the reported amounts in the literature without the use of BonAlive® putty.
timeFrame: 24 months
Locations:
city: Turku
country: Finland
facility: Turku University Hospital Department of Neurosurgery
Study officials:
affiliation: Turku University Hospital
name: Ilkka Saarenpää, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: