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

Turku University Hospital (TYKS)

Status

Completed

Conditions

Bone Neoplasm

Treatments

Device: Bioactive glass

Procedure: Autograft

Procedure: Allograft (frozen femoral head)

Device: Beta-tricalcium phosphate (ChronOs)

Study type

Observational

Funder types

Other

Identifiers

NCT00841152

139/180/2008

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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