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

• Conditions: Spine Fusion; Spinal Deformity
• Interventions: Device: S53P4 bioactive glass putty

• Registration Number: NCT05001893
• Lead Sponsor: Bonalive Biomaterials Ltd

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.

Study Timeline

• Study Start: 2021-05-03
• Study First Submitted: 2021-05-04
• Status Verified: 2021-07
• Study First Submitted QC: 2021-08-11
• Last Update Submitted: 2021-08-11
• Study First Posted: 2021-08-12
• Last Update Posted: 2021-08-12
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Not specified
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The use of a mixture of BonAlive® putty and autologous bone	S53P4 bioactive glass putty	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.

Primary Outcome Measures

Name	Time	Method
15 D questionnaire The 15D is a generic, comprehensive (15-dimensional), self-administered instrument for measuring HRQoL among adults.	24 months	Health index on a 0-1 scale has been used successfully in several pharmacoeconomic evaluations. The maximum score is 1 (no problems on any dimension) and the minimum score is 0 (being dead).
To demonstrate the clinical efficacy of BonAlive® (S53P4 bioactive glass) putty in spine fusion operations when used alone and together with autologous bone.	24 months	Radiologic endpoints are based on a neuroradiologist evaluatyion possible complications (breakage and/or loosening of the instrumentation) and bony fusion on a modified Bridwell grading criteria I-IV for PLF.
Clinical outcomes are for pain VAS:	24 months	Visual analogue scale 1-10.
EQ-5D cost effectiviness questionnaires.	24 months	Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation.
ODI: (Oswestry Low Back Pain Disability Questionnaire).	24 months	ODI is validated to use in patients with low back pain.The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.

Secondary Outcome Measures

Name	Time	Method
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.	24 months	Radiologic endpoints are based on a neuroradiologist evaluation possible complications; 1. breakage and/or loosening of the instrumentation 2. bony fusion on a modified Bridwell grading criteria for PLF.
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.	24 months	Odom´s scale; 1 Excellent: No symptoms related to cervicaldisease.Able to perform daily activities without limitations. 2 Good: Moderate symptoms related tocervical disease.Able to perform daily activities without significant limitations. 3 Satisfactory: Slight improvement in symptomsrelated to cervical disease.Significant limitations in daily activities. 4 Poor: No improvement in, or aggravation of,symptoms related to cervical disease.Not able to perform daily activities.

Trial Locations

Locations (1)

Turku University Hospital Department of Neurosurgery; 🇫🇮 Turku, Finland