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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: 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

Brief 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 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. 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.
Sponsor: Turku University Hospital

Current Primary Outcome:

  • Stratum I: Hand-grip strength test [ Time Frame: 3 months ]
  • Stratum II: Healing of cortical bone window based on CT scan evaluation [ Time Frame: 6 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Biomaterial incorporation assessed with radiographs [ Time Frame: 3, 6, and 12 months ]
  • Pain intensity (VAS) [ Time Frame: 3,6, and 12 months ]
  • Stratum I: DASH-questionnaire [ Time Frame: 3,6, and 12 months ]
  • RAND-36 [ Time Frame: 3,6, and 12 months ]
  • Surgical wound healing [ Time Frame: 0-3 months ]
  • Soft tissue complications [ Time Frame: 0-12 months ]
  • Bone complications [ Time Frame: 0-12 months ]


Original Secondary Outcome:

  • Biomaterial incorporation assessed with radiographs [ Time Frame: 3, 6, and 12 months ]
  • Pain intensity (VAS) [ Time Frame: 3,6, and 12 months ]
  • Stratum I: DASH-questionnaire [ Time Frame: 3,6, and 12 months ]
  • SF-36 [ Time Frame: 3,6, and 12 months ]
  • Surgical wound healing [ Time Frame: 0-3 months ]
  • Soft tissue complications [ Time Frame: 0-12 months ]
  • Bone complications [ Time Frame: 0-12 months ]


Information By: Turku University Hospital

Dates:
Date Received: February 10, 2009
Date Started: March 2009
Date Completion: December 2018
Last Updated: February 10, 2017
Last Verified: February 2017