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

Turku University Hospital120 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Bone Neoplasm

Interventions

Bioactive glassDEVICE

Surgical implantation

Beta-tricalcium phosphate (ChronOs)DEVICE

Surgical implantation

AutograftPROCEDURE

Surgical transplantation from iliac crest

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Helsinki University Hospital

Helsinki, Finland

Kuopio University Hospital

Kuopio, Finland

Oulu University Hospital

Oulu, Finland

Tampere University Hsopital

Tampere, Finland

Turku University Central Hospital

Outcomes

Primary Outcomes

Stratum I: Hand-grip strength test

Hand and finger grip strength measured by a standard device

Time frame: 3 months

Stratum II: Healing of cortical bone window based on CT scan evaluation

CT-evaluation of cortical defect healing

Time frame: 6 months

Secondary Outcomes

Biomaterial incorporation assessed with radiographs

Radiographic evaluation of bioactive glass and bone graft incorporation

Time frame: 3, 6, and 12 months

Pain intensity (VAS)

Evaluation of postoperative pain

Time frame: 3,6, and 12 months

Stratum I: DASH-questionnaire

Evaluation of patient-related outcome

Time frame: 3,6, and 12 months

RAND-36

Evaluation of patient-related outcome

Time frame: 3,6, and 12 months

Surgical wound healing

Clinical evaluation of surgical wound healing

Time frame: 0-3 months

Soft tissue complications

Clinical evaluation of soft tissue complications in the surgical area

Time frame: 0-12 months

Bone complications

Clinical and radiographic evaluation of complications of bone defect healing

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.