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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Bone Neoplasm
- Sponsor
- Turku University Hospital
- Enrollment
- 120
- Locations
- 5
- Primary Endpoint
- Stratum II: Healing of cortical bone window based on CT scan evaluation
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with primary or recurrent benign bone tumor or tumor-like condition that requires operative treatment by means of tumor evacuation and defect filling
- •Pathological fractures of patients in Stratum I are treated by means of conservative treatment for three months before tumor surgery
Exclusion Criteria
- •History of acute or chronic local infection
- •History of malignancy (excluding carcinoma basocellular) within past 5 years
- •A history of local radiotherapy
- •A known metabolic skeletal disease (such as osteoporosis, Paget's disease or osteomalacia)
- •Medication affecting bone turnover (oral bisphosphonates, PTH, sodium fluoride, strontium ranelate, calcitonin, testosterone, systemic cortico- or anabolic steroids)
- •Any plans to use phenol or other chemical/thermal method of local tumor control
- •Pregnancy
- •Any other condition that in the judgment of the investigator, would prohibit the subject from participating in the study or may hinder the collection of data and interpretation of the results
Outcomes
Primary Outcomes
Stratum II: Healing of cortical bone window based on CT scan evaluation
Time Frame: 6 months
CT-evaluation of cortical defect healing
Stratum I: Hand-grip strength test
Time Frame: 3 months
Hand and finger grip strength measured by a standard device
Secondary Outcomes
- Pain intensity (VAS)(3,6, and 12 months)
- Bone complications(0-12 months)
- Biomaterial incorporation assessed with radiographs(3, 6, and 12 months)
- RAND-36(3,6, and 12 months)
- Soft tissue complications(0-12 months)
- Stratum I: DASH-questionnaire(3,6, and 12 months)
- Surgical wound healing(0-3 months)