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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Spinal Deformity; Spine Fusion
• Intervention / Treatment: Device: S53P4 bioactive glass putty

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland, 207520
    • Turku University Hospital Department of Neurosurgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
The use of a mixture of BonAlive® putty and autologous bone; 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.	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.; Other Names: Bonalive® putty, Bonalive® putty MIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To demonstrate the clinical efficacy of BonAlive® (S53P4 bioactive glass) putty in spine fusion operations when used alone and together with autologous bone.	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.	24 months
Clinical outcomes are for pain VAS:	Visual analogue scale 1-10.	24 months
EQ-5D cost effectiviness questionnaires.	Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation.	24 months
ODI: (Oswestry Low Back Pain Disability Questionnaire).	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.	24 months
15 D questionnaire The 15D is a generic, comprehensive (15-dimensional), self-administered instrument for measuring HRQoL among adults.	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).	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	24 months
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.	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.	24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
• 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.	Re-operations and infections in the area of surgery.	24 months

Collaborators and Investigators

• Sponsor: Bonalive Biomaterials Ltd
• Collaborators: Turku University Hospital
• Investigators: Principal Investigator: Ilkka Saarenpää, MD, PhD, Turku University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: August 11, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 11, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: S53P4; Bonalive; Bioactive glass putty; Spine fusion; Lumbar spine fusion
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 103-CL01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No