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

Completed

• Conditions: Bone Neoplasm
• Interventions: Device: Bioactive glass; Device: Beta-tricalcium phosphate (ChronOs); Procedure: Allograft (frozen femoral head); Procedure: Autograft

• Registration Number: NCT00841152
• Lead Sponsor: Turku University Hospital

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.

Study Timeline

• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Study Start: 2009-03
• Primary Completion: 2014-02
• Study Completion: 2018-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-12
• Last Update Posted: 2021-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hand lesions	Bioactive glass	Stratum I: comparison of three interventions (autograft, bioactive glass and beta-tricalcium phosphate)
Hand lesions	Beta-tricalcium phosphate (ChronOs)	Stratum I: comparison of three interventions (autograft, bioactive glass and beta-tricalcium phosphate)
Long-bone lesions	Allograft (frozen femoral head)	Stratum II: comparison of three interventions (bioactive glass, beta-tricalcium phosphate, allograft)
Hand lesions	Autograft	Stratum I: comparison of three interventions (autograft, bioactive glass and beta-tricalcium phosphate)
Long-bone lesions	Bioactive glass	Stratum II: comparison of three interventions (bioactive glass, beta-tricalcium phosphate, allograft)
Long-bone lesions	Beta-tricalcium phosphate (ChronOs)	Stratum II: comparison of three interventions (bioactive glass, beta-tricalcium phosphate, allograft)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Oulu University Hospital; 🇫🇮 Oulu, Finland

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Turku University Central Hospital; 🇫🇮 Turku, Finland

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Tampere University Hsopital; 🇫🇮 Tampere, Finland