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

Spinal Deformity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05001893
• Other study ID #: 103-CL01
• Status: Active, not recruiting
• Start date: May 3, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: Bonalive Biomaterials Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Spinal Deformity
• Spine Fusion

Intervention

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.

Locations

Country	Name	City	State
Finland	Turku University Hospital Department of Neurosurgery	Turku

Sponsors (2)

Lead Sponsor	Collaborator
Bonalive Biomaterials Ltd	Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	• 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
Primary	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
Primary	Clinical outcomes are for pain VAS:	Visual analogue scale 1-10.	24 months
Primary	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
Primary	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
Primary	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	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
Secondary	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