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

NCT05001893 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2021-08-12

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Turku University Hospital

    collaborator OTHER_GOV

  • Bonalive Biomaterials Ltd

    lead INDUSTRY

Principal Investigators

  • Ilkka Saarenpää, MD, PhD · Turku University Hospital

Eligibility

Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05001893 on ClinicalTrials.gov