Bioactive Glass Granules in Filling of Bone Defects

This study has been completed.
Sponsor:
Information provided by:
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01304121
First received: February 21, 2011
Last updated: June 15, 2011
Last verified: June 2011
  Purpose

This is a randomized clinical trial that will be carried out to examine the use of bioactive glass granules (S53P4) as bone graft substitute in filling small and large bone defects as compared with autogenous and allogeneic bone grafting, respectively.


Condition Intervention Phase
Bone Tumors
Device: Bioactive glass (SP53P4)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Bioactive Glass Granules as Bone Graft Substitute in Filling Material of Bone Defects

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • Radiological healing [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    The healing of bone defects will be examined by plain X-rays and MRI


Secondary Outcome Measures:
  • Clinical recovery [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    The outcome of the surgical procedure (i.e. the subjective recovery of the patients) will be evaluated by means of Rand-36 scoring system

  • PET imaging [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    PET imaging will be applied to measure blood flow and metabolic activity at the surgical site


Enrollment: 48
Study Start Date: October 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bioactive glass
Resorbable bioactive glass granules
Device: Bioactive glass (SP53P4)
Commercial resorbable bone graft substitute (Vioxid Ltd)
Other Name: Abmin (trademark), Vioxid Ltd

Detailed Description:

This a single center randomized trial. The hypothesis of the study is that the selected synthetic bone graft (bioactive glass granules, S53P4, Vivoxid Ltd, Turku, Finland) is as good as traditional autogenous or allogeneic bone grating in filling of non-traumatic bone defects. A total of 48 patients (stratified into two groups) will be included. The underlying bone disease will include common bening and semi-malign bone tumors (such as enchondroma and giant cell tumors) as well as tumor-like conditions (such as fibrous dysplasia, fibrous cortical defect, solitary bone cysts, aneurysmatic bone cyst).

Group I (n=24) will include patients with small benign bone lesions amenable to evacuation and autogenous bone grafting as standard of care. The patients will be randomized to autogenous bone grafting or bioactive glass granule filling. The follow-up examinations up to 52 weeks will include plain X-rays at 4, 26, and 52 weeks as well as MRI ad 4 and 52 weeks.

Group II (n=24) will include patients with a large bone defect. As the selection criteria, large defects have been defined to be defects which need allogeneic bone grafting. The patients will be randomized to allogeneic bone grafting or bioactive glass granule filling. The patients will be followed up to 52 weeks. The follow-up examinations will include X-rays at 4, 26 and 52 weeks as well as PET/CT imaging and MRI at 4 weeks and 52 weeks.

  Eligibility

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

Inclusion Criteria:

  • benign bone tumor or tumor-like condition
  • age 18 years or more
  • signed informed consent

Exclusion Criteria:

  • a history of malignancy
  • a medication affecting bone metabolism
  • any device (such as pace maker) as contraindication for MRI imaging
  • gravidity
  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: NCT01304121

Locations
Finland
Turku University Hospital
Turku, Finland, 20520
Sponsors and Collaborators
Turku University Hospital
Investigators
Principal Investigator: Hannu T Aro, MD, PhD Turku University Hospital
  More Information

Additional Information:
Publications:

Responsible Party: Hannu T Aro, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01304121     History of Changes
Other Study ID Numbers: VSSHP#2701/2007
Study First Received: February 21, 2011
Last Updated: June 15, 2011
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Turku University Hospital:
Bone tumors
Bioactive glass
Autogenous bone grafting
Allogeneic bone grafting
PET imaging

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

ClinicalTrials.gov processed this record on August 01, 2014