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

March 12, 2021 updated by: Turku University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Hospital
      • Kuopio, Finland, 70211
        • Kuopio University Hospital
      • Oulu, Finland, 90220
        • Oulu University Hospital
      • Tampere, Finland, 33521
        • Tampere University Hsopital
      • Turku, Finland, 20520
        • Turku University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patients with primary or recurrent benign bone tumor or tumor-like condition that requires operative treatment by means of tumor evacuation and defect filling.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Investigators

  • Principal Investigator: Hannu T Aro, MD, PhD, Turku University Central Hospital and University of Turku

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2009

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

February 10, 2009

First Submitted That Met QC Criteria

February 10, 2009

First Posted (Estimate)

February 11, 2009

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 12, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 139/180/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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