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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Turku University Hospital
Sponsor:
Information provided by (Responsible Party):
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT00841152
First received: February 10, 2009
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Bone Neoplasm
Device: Bioactive glass
Device: Beta-tricalcium phosphate (ChronOs)
Procedure: Autograft
Procedure: Allograft (frozen femoral head)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • Stratum I: Hand-grip strength test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Stratum II: Healing of cortical bone window based on CT scan evaluation [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biomaterial incorporation assessed with radiographs [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
  • Pain intensity (VAS) [ Time Frame: 3,6, and 12 months ] [ Designated as safety issue: Yes ]
  • Stratum I: DASH-questionnaire [ Time Frame: 3,6, and 12 months ] [ Designated as safety issue: No ]
  • RAND-36 [ Time Frame: 3,6, and 12 months ] [ Designated as safety issue: No ]
  • Surgical wound healing [ Time Frame: 0-3 months ] [ Designated as safety issue: Yes ]
  • Soft tissue complications [ Time Frame: 0-12 months ] [ Designated as safety issue: Yes ]
  • Bone complications [ Time Frame: 0-12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: March 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Hand lesions
Stratum I: comparison of three interventions (autograft, bioactive glass and beta-tricalcium phosphate)
Device: Bioactive glass
Surgical implantation
Other Name: Bonalive (Vivoxid Ltd, Turku, Finland)
Device: Beta-tricalcium phosphate (ChronOs)
Surgical implantation
Other Name: 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 Name: Bonalive (Vivoxid Ltd, Turku, Finland)
Device: Beta-tricalcium phosphate (ChronOs)
Surgical implantation
Other Name: ChronOs (Synthes, Solothurn, Switzerland)
Procedure: Allograft (frozen femoral head)
Surgical transplantation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841152

Contacts
Contact: Hannu T Aro, MD,PhD +358-40-3537644 hannu.aro@utu.fi
Contact: Satu J Timlin, RN +358-50-4381824 satu.timlin@utu.fi

Locations
Finland
Helsinki University Hospital Recruiting
Helsinki, Finland, 00029
Contact: Aarne Kivioja, MD,PhD         
Principal Investigator: Aarne Kivioja, MD,PhD         
Kuopio University Hospital Recruiting
Kuopio, Finland, 70211
Contact: Heikki Kröger, MD,PhD         
Principal Investigator: Heikki Kröger, MD,PhD         
Oulu University Hospital Recruiting
Oulu, Finland, 90220
Contact: Juhana Leppilahti, MD,PhD         
Principal Investigator: Juhana Leppilahti, MD,PhD         
Tampere University Hsopital Recruiting
Tampere, Finland, 33521
Contact: Minna Laitinen, MD,PhD         
Principal Investigator: Minna Laitinen, MD,PhD         
Turku University Central Hospital Recruiting
Turku, Finland, 20520
Contact: Hannu T Aro, MD,PhD         
Principal Investigator: Hannu T Aro, MD,PhD         
Sponsors and Collaborators
Turku University Hospital
Investigators
Principal Investigator: Hannu T Aro, MD, PhD Turku University Central Hospital and University of Turku
  More Information

Additional Information:
Publications:

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT00841152     History of Changes
Other Study ID Numbers: 139/180/2008
Study First Received: February 10, 2009
Last Updated: February 14, 2014
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Turku University Hospital:
Bone tumors
Surgery
Bone graft substitutes
Bioactive glass
Bioceramics
Bone autograft
Bone allograft

Additional relevant MeSH terms:
Bone Neoplasms
Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Methamphetamine
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014