Bone Neoplasm
Conditions
Keywords
Bone tumors, Surgery, Bone graft substitutes, Bioactive glass, Bioceramics, Bone autograft, Bone allograft
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.
Interventions
PROCEDUREAutograft
Surgical transplantation from iliac crest
DEVICEBioactive glass
Surgical implantation
DEVICEBeta-tricalcium phosphate (ChronOs)
Surgical implantation
PROCEDUREAllograft (frozen femoral head)
Surgical transplantation
Sponsors
Turku University Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stratum I: Hand-grip strength test | 3 months | Hand and finger grip strength measured by a standard device |
| Stratum II: Healing of cortical bone window based on CT scan evaluation | 6 months | CT-evaluation of cortical defect healing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stratum I: DASH-questionnaire | 3,6, and 12 months | Evaluation of patient-related outcome |
| RAND-36 | 3,6, and 12 months | Evaluation of patient-related outcome |
| Biomaterial incorporation assessed with radiographs | 3, 6, and 12 months | Radiographic evaluation of bioactive glass and bone graft incorporation |
| Soft tissue complications | 0-12 months | Clinical evaluation of soft tissue complications in the surgical area |
| Bone complications | 0-12 months | Clinical and radiographic evaluation of complications of bone defect healing |
| Surgical wound healing | 0-3 months | Clinical evaluation of surgical wound healing |
| Pain intensity (VAS) | 3,6, and 12 months | Evaluation of postoperative pain |
Countries
Finland
Outcome results
None listed