Depressed Lateral Condyle FractureNCT00935870
Bioactive Glass as Bone Graft Substitute in Operative Treatment of Bone - a 10 Years Follow-up Study
An observational study of Depressed Lateral Condyle Fracture and Benign Bone Tumour Cavity, run by Vivoxid Ltd at 1 site in Finland.
Trial summary
The main aim is to evaluate the long-term safety and bone healing in the operated area and to compare bioactive glass granules with autogenous bone as a filler material. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Depressed Lateral Condyle Fracture, Benign Bone Tumour Cavity, Spinal Fusion
- What is being tested?
- Bioactive glass and/or autogenous bone
- Type of treatment
- Medical device
- How many people
- 63 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2008to Feb 2009
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects who participated to previous clinical investigations with bioactive glass about 10 years ago.
Who may be able to join
- Written informed consent obtained; Participation of previous clinical investigation with bioactive glass
Who cannot join
- The subject is unlikely to adhere to study procedures
- Concurrent disease or condition that in the opinion of the investigator is contraindicating participation
- Simultaneous participation in another medical device or investigational drug trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioactive Glass (S53P4) as Bone Graft Substitute in Operative Treatment of Depressed Lateral Condyle Fractures, Benign Bone Tumour Cavities and in Spinal Fusion - a 10 Years Follow-up and Bone Density Study.
The main aim is to evaluate the long-term safety and bone healing in the operated area and to compare bioactive glass granules with autogenous bone as a filler material.
- Being tested
- Bioactive glass and/or autogenous bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioactive glass and/or autogenous boneDevice
No intervention in the current study (10-year follow-up study)
| Study group | Role | What they receive |
|---|---|---|
| A | DEPRESSED LATERAL CONDYLE FRACTURE Receives: Device: Bioactive glass and/or autogenous bone | |
| B | BENIGN BONE TUMOR Receives: Device: Bioactive glass and/or autogenous bone | |
| C | SPINAL FUSION Receives: Device: Bioactive glass and/or autogenous bone |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressed Lateral Condyle FractureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivoxid Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Nina Lindfors, MD, Principal investigator, Turku University Hospital/Helsinki University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935870
- Sponsor's protocol ID
- 1005-3
- Status last verified
- Jul 2009
- First submitted
- 7 Jul 2009
- Last updated
- 9 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioactive Glass (S53P4) as Bone Graft Substitute in Operative Treatment of Depressed Lateral Condyle Fractures, Benign Bone Tumour Cavities and in Spinal Fusion - a 10 Years Follow-up and Bone Density Study.
- ClinicalTrials.gov ID
- NCT00935870
- Acronym / sponsor ID
- 1005-3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Vivoxid LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 9 Jul 2009 (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.
The main aim is to evaluate the long-term safety and bone healing in the operated area and to compare bioactive glass granules with autogenous bone as a filler material.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | – | Device: Bioactive glass and/or autogenous boneDEPRESSED LATERAL CONDYLE FRACTURE |
| B | – | Device: Bioactive glass and/or autogenous boneBENIGN BONE TUMOR |
| C | – | Device: Bioactive glass and/or autogenous boneSPINAL FUSION |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who participated to previous clinical investigations with bioactive glass about 10 years ago.
Key inclusion criteria (1 listed)
- Written informed consent obtained; Participation of previous clinical investigation with bioactive glass
Key exclusion criteria (3 listed)
- The subject is unlikely to adhere to study procedures
- Concurrent disease or condition that in the opinion of the investigator is contraindicating participation
- Simultaneous participation in another medical device or investigational drug trial
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 and/or autogenous boneNo intervention in the current study (10-year follow-up study) | Device | A, B, C |
Primary outcome
Not reported in the source record.
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 9 Jul 2009.
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.
Nina Lindfors, MD principal investigator
Turku University Hospital/Helsinki University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressed Lateral Condyle Fracture and Benign Bone Tumour Cavity, run by Vivoxid Ltd 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 1 inclusion and 3 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 9 Jul 2009. 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.
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.
Where can I read the original study information?
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 9 Jul 2009.