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

NCT05001893 | Unknown DMC

• 1 other identifier: 103-CL01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Fusion; Spinal Deformity

Keywords

S53P4; Bonalive; Bioactive glass putty; Spine fusion; Lumbar spine fusion

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• 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

• 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

Other Outcomes (1)

• • 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

Study Arms (1)

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

Interventions

S53P4 bioactive glass putty DEVICE

Bonalive putty/putty MIS paste is a synthetic, bioactive, osteoconductive, osteostimulative bone void filler for filling, reconstruction, and regeneration of bone defects.

Also known as: Bonalive® putty, Bonalive® putty MIS

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

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Performed spine fusion operation
• BonAlive® putty used in the operation

You may not qualify if:

• Age under 18
• Use of other synthetic bone graft substitute or expander materials than BonAlive® putty in the operation
• Less time than two years since the index operation and no CT-proof of intended bony fusion

Sponsors & Collaborators

• Bonalive Biomaterials Ltd: lead
• Turku University Hospital: collaborator

Study Sites (1)

Turku University Hospital Department of Neurosurgery

Turku, 207520, Finland

Location

Study Officials

• Ilkka Saarenpää, MD, PhD

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: August 12, 2021
• Study Start: May 3, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 12, 2021

Record last verified: 2021-07

Locations

FI (1)