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A National, Prospective, Randomized, Multicenter, Controlled Head-to-Head Comparison of Bioactive Glass and Beeta-Tricalcium Phosphate as Bone Graft Substitute in Filling of Contained Bone Defects


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Bone Neoplasm

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Trial Information

A National, Prospective, Randomized, Multicenter, Controlled Head-to-Head Comparison of Bioactive Glass and Beeta-Tricalcium Phosphate as Bone Graft Substitute in Filling of Contained Bone Defects


This study is designed to perform a head-to-head comparison of two synthetic ceramic bone
graft substitutes, bioactive glass (BAG) and beeta-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 SOC controls.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Stratum I: Hand-grip strength test

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Hannu T Aro, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Turku University Central Hospital and University of Turku

Authority:

Finland: Finnish Medicines Agency

Study ID:

139/180/2008

NCT ID:

NCT00841152

Start Date:

March 2009

Completion Date:

December 2014

Related Keywords:

  • Bone Neoplasm
  • Bone tumors
  • Surgery
  • Bone graft substitutes
  • Bioactive glass
  • Bioceramics
  • Bone autograft
  • Bone allograft
  • Bone Neoplasms
  • Neoplasms

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