Bone TumorsPhase 4NCT01304121
Bioactive Glass Granules in Filling of Bone Defects
A Phase 4 study testing Bioactive glass (SP53P4) in people with Bone Tumors, run by Turku University Hospital at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Tumors
- What is being tested?
- Bioactive glass (SP53P4)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFinland
- Study dates
- Oct 2006to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- benign bone tumor or tumor-like condition
- age 18 years or more
- signed informed consent
Who cannot join
- a history of malignancy
- a medication affecting bone metabolism
- any device (such as pace maker) as contraindication for MRI imaging
- gravidity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioactive Glass Granules as Bone Graft Substitute in Filling Material of Bone Defects
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.
Read the 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.
- Conditions
- Bone Tumors
- Being tested
- Bioactive glass (SP53P4)
- Keywords
- Bone tumors, Bioactive glass, Autogenous bone grafting, Allogeneic bone grafting, PET imaging
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioactive glass (SP53P4)Device
Also called Abmin (trademark), Vioxid Ltd
Commercial resorbable bone graft substitute (Vioxid Ltd)
| Study group | Role | What they receive |
|---|---|---|
| Bioactive glass | Experimental | Resorbable bioactive glass granules Receives: Device: Bioactive glass (SP53P4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological healing
The healing of bone defects will be examined by plain X-rays and MRI
Measured: 52 weeks
Secondary outcomes (2)
Clinical recovery
The outcome of the surgical procedure (i.e. the subjective recovery of the patients) will be evaluated by means of Rand-36 scoring system
Measured: 52 weeks
PET imaging
PET imaging will be applied to measure blood flow and metabolic activity at the surgical site
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startOct 2006
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Bone TumorsStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Investigators
- Hannu T Aro, MD, PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304121
- Sponsor's protocol ID
- VSSHP#2701/2007
- Status last verified
- Jun 2011
- First submitted
- 21 Feb 2011
- Last updated
- 16 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Valimaki VV, Aro HT. Molecular basis for action of bioactive glasses as bone graft substitute. Scand J Surg. 2006;95(2):95-102. doi: 10.1177/145749690609500204.
PubMed 16821652Valimaki VV, Moritz N, Yrjans JJ, Vuorio E, Aro HT. Effect of zoledronic acid on incorporation of a bioceramic bone graft substitute. Bone. 2006 Mar;38(3):432-43. doi: 10.1016/j.bone.2005.09.016. Epub 2005 Dec 9.
PubMed 16338190Keranen P, Itala A, Koort J, Kohonen I, Dalstra M, Kommonen B, Aro HT. Bioactive glass granules as extender of autogenous bone grafting in cementless intercalary implant of the canine femur. Scand J Surg. 2007;96(3):243-51. doi: 10.1177/145749690709600310.
PubMed 17966751Zhao D, Moritz N, Vedel E, Hupa L, Aro HT. Mechanical verification of soft-tissue attachment on bioactive glasses and titanium implants. Acta Biomater. 2008 Jul;4(4):1118-22. doi: 10.1016/j.actbio.2008.02.012. Epub 2008 Mar 4.
PubMed 18356122Koort JK, Suokas E, Veiranto M, Makinen TJ, Jalava J, Tormala P, Aro HT. In vitro and in vivo testing of bioabsorbable antibiotic containing bone filler for osteomyelitis treatment. J Biomed Mater Res A. 2006 Sep 1;78(3):532-40. doi: 10.1002/jbm.a.30766.
PubMed 16736479Alm JJ, Frantzen JP, Moritz N, Lankinen P, Tukiainen M, Kellomaki M, Aro HT. In vivo testing of a biodegradable woven fabric made of bioactive glass fibers and PLGA80--a pilot study in the rabbit. J Biomed Mater Res B Appl Biomater. 2010 May;93(2):573-80. doi: 10.1002/jbm.b.31618.
PubMed 20229522Keranen P, Koort J, Itala A, Ylanen H, Dalstra M, Hupa M, Kommonen B, Aro HT. Bioceramic inlays do not improve mechanical incorporation of grit-blasted titanium stems in the proximal sheep femur. J Biomed Mater Res A. 2010 Mar 15;92(4):1578-86. doi: 10.1002/jbm.a.32494.
PubMed 19437438
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioactive Glass Granules as Bone Graft Substitute in Filling Material of Bone Defects
- ClinicalTrials.gov ID
- NCT01304121
- Acronym / sponsor ID
- VSSHP#2701/2007
- Conditions
- Bone Tumors
- Keywords
- Bone tumors, Bioactive glass, Autogenous bone grafting, Allogeneic bone grafting, PET imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Oct 2006
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 25 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bioactive glass | Experimental | Device: Bioactive glass (SP53P4)Resorbable bioactive glass granules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- benign bone tumor or tumor-like condition
- age 18 years or more
- signed informed consent
Key exclusion criteria (4 listed)
- a history of malignancy
- a medication affecting bone metabolism
- any device (such as pace maker) as contraindication for MRI imaging
- gravidity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioactive glass (SP53P4)Also: Abmin (trademark), Vioxid LtdCommercial resorbable bone graft substitute (Vioxid Ltd) | Device | Bioactive glass |
Primary outcome
Radiological healing
Time frame: 52 weeks
The healing of bone defects will be examined by plain X-rays and MRI
2 secondary outcomes
Clinical recovery
Time frame: 52 weeks
PET imaging
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
- Background: PubMed 16821652Valimaki VV, Aro HT. Molecular basis for action of bioactive glasses as bone graft substitute. Scand J Surg. 2006;95(2):95-102. doi: 10.1177/145749690609500204.
- Background: PubMed 16338190Valimaki VV, Moritz N, Yrjans JJ, Vuorio E, Aro HT. Effect of zoledronic acid on incorporation of a bioceramic bone graft substitute. Bone. 2006 Mar;38(3):432-43. doi: 10.1016/j.bone.2005.09.016. Epub 2005 Dec 9.
- Background: PubMed 17966751Keranen P, Itala A, Koort J, Kohonen I, Dalstra M, Kommonen B, Aro HT. Bioactive glass granules as extender of autogenous bone grafting in cementless intercalary implant of the canine femur. Scand J Surg. 2007;96(3):243-51. doi: 10.1177/145749690709600310.
- Background: PubMed 18356122Zhao D, Moritz N, Vedel E, Hupa L, Aro HT. Mechanical verification of soft-tissue attachment on bioactive glasses and titanium implants. Acta Biomater. 2008 Jul;4(4):1118-22. doi: 10.1016/j.actbio.2008.02.012. Epub 2008 Mar 4.
- Background: PubMed 16736479Koort JK, Suokas E, Veiranto M, Makinen TJ, Jalava J, Tormala P, Aro HT. In vitro and in vivo testing of bioabsorbable antibiotic containing bone filler for osteomyelitis treatment. J Biomed Mater Res A. 2006 Sep 1;78(3):532-40. doi: 10.1002/jbm.a.30766.
- Background: PubMed 20229522Alm JJ, Frantzen JP, Moritz N, Lankinen P, Tukiainen M, Kellomaki M, Aro HT. In vivo testing of a biodegradable woven fabric made of bioactive glass fibers and PLGA80--a pilot study in the rabbit. J Biomed Mater Res B Appl Biomater. 2010 May;93(2):573-80. doi: 10.1002/jbm.b.31618.
- Background: PubMed 19437438Keranen P, Koort J, Itala A, Ylanen H, Dalstra M, Hupa M, Kommonen B, Aro HT. Bioceramic inlays do not improve mechanical incorporation of grit-blasted titanium stems in the proximal sheep femur. J Biomed Mater Res A. 2010 Mar 15;92(4):1578-86. doi: 10.1002/jbm.a.32494.
- Homepage of the clinical research unitLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannu T Aro, MD, PhD principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bioactive glass (SP53P4) in people with Bone Tumors, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological healing (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01304121, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2011.