NCT00841152

Comparison of Bioactive Glass and Beta-Tricalcium Phosphate as Bone Graft Substitute

A National, Prospective, Randomized, Multicenter, Controlled Head-to-Head Comparison of Bioactive Glass and Beta-Tricalcium Phosphate as Bone Graft Substitute in Filling of Contained Bone Defects

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Turku University Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to perform a head-to-head comparison of two synthetic ceramic bone graft substitutes, bioactive glass (BAG) and beta-tricalcium phosphate (TCP), in filling of contained bone defects following surgical evacuation of benign bone tumor or tumor-like conditions. Based on the investigators' previous preclinical research and an ongoing single-center randomized clinical trial on bioactive glass filling, the investigators expect BAG filling to be more efficient compared to TCP in promotion of defect healing and functional recovery after surgery.

Detailed description

This study is designed to perform a head-to-head comparison of two synthetic ceramic bone graft substitutes, bioactive glass (BAG) and beta-tricalcium phosphate (TCP), in filling of contained bone defects following surgical evacuation of benign bone tumor or tumor-like conditions. Small metacarpal and phalangeal enchondromas (Stratum I) and large long-bone lesions (Stratum II) will be evaluated separately. Aside with the head-to-head comparison of the two synthetic bone graft substitutes, autologous bone graft (Stratum I) and allogeneic bone graft (Stratum II) will be used as the standard of care controls.

Conditions

• Bone Neoplasm

Interventions

Type	Name	Description
DEVICE	Bioactive glass	Surgical implantation
DEVICE	Beta-tricalcium phosphate (ChronOs)	Surgical implantation
PROCEDURE	Autograft	Surgical transplantation from iliac crest
PROCEDURE	Allograft (frozen femoral head)	Surgical transplantation

Timeline

• Start date: 2009-03-01
• Primary completion: 2014-02-01
• Completion: 2018-12-01
• First posted: 2009-02-11
• Last updated: 2021-03-16

Locations

5 sites across 1 country: Finland