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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Bone Neoplasm

Intervention / Treatment
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* Device: Bioactive glass
* Device: Beta-tricalcium phosphate (ChronOs)
* Procedure: Autograft
* Procedure: Allograft (frozen femoral head)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hand lesions<br>Stratum I: comparison of three interventions (autograft, bioactive glass and beta-tricalcium phosphate) | Device: Bioactive glass<br>* Surgical implantation<br>* Other names: Bonalive (Vivoxid Ltd, Turku, Finland);Device: Beta-tricalcium phosphate (ChronOs)<br>* Surgical implantation<br>* Other names: ChronOs (Synthes, Solothurn, Switzerland);Procedure: Autograft<br>* Surgical transplantation from iliac crest<br>|
| Long-bone lesions<br>Stratum II: comparison of three interventions (bioactive glass, beta-tricalcium phosphate, allograft) | Device: Bioactive glass<br>* Surgical implantation<br>* Other names: Bonalive (Vivoxid Ltd, Turku, Finland);Device: Beta-tricalcium phosphate (ChronOs)<br>* Surgical implantation<br>* Other names: ChronOs (Synthes, Solothurn, Switzerland);Procedure: Allograft (frozen femoral head)<br>* Surgical transplantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stratum I: Hand-grip strength test | Hand and finger grip strength measured by a standard device | 3 months | 
| Stratum II: Healing of cortical bone window based on CT scan evaluation | CT-evaluation of cortical defect healing | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomaterial incorporation assessed with radiographs | Radiographic evaluation of bioactive glass and bone graft incorporation | 3, 6, and 12 months | 
| Pain intensity (VAS) | Evaluation of postoperative pain | 3,6, and 12 months | 
| Stratum I: DASH-questionnaire | Evaluation of patient-related outcome | 3,6, and 12 months | 
| RAND-36 | Evaluation of patient-related outcome | 3,6, and 12 months | 
| Surgical wound healing | Clinical evaluation of surgical wound healing | 0-3 months | 
| Soft tissue complications | Clinical evaluation of soft tissue complications in the surgical area | 0-12 months | 
| Bone complications | Clinical and radiographic evaluation of complications of bone defect healing | 0-12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone tumors, Surgery, Bone graft substitutes, Bioactive glass, Bioceramics, Bone autograft, Bone allograft