PseudarthrosisNCT01756144
rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport
A study testing rhBMP-2 in people with Pseudarthrosis, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
When there is a bone defect, bone transport is used to bridge the defect. Frequently, the bone in the docking site (where the transported bone comes together) doesn't heal. The objective is to study the effectivity of rhBmp-2 (inductos) to stimulate bone healing, in order to find new techniques to treat non-union of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pseudarthrosis
- What is being tested?
- rhBMP-2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Apr 2016
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients treated with bone transport (Ilizarov technique) and have non-union of the docking site, which is characterized by absence of bridging callus after two months of compression in the docking site.
Who cannot join
- Allergy for inductos
- active growth,
- malignancy
- infection
- PAD
- pathological fracture
About this study
When there is a bone defect, bone transport is used to bridge the defect. Frequently, the bone in the docking site (where the transported bone comes together) doesn't heal.
The objective is to study the effectivity of rhBmp-2 (inductos) to stimulate bone healing, in order to find new techniques to treat non-union of long bones.
The method of the study is a randomized controlled trial, to compare rhBMP-2 and autologous bone grafting in stimulating bone healing in the docking site.
- Conditions
- Pseudarthrosis
- Being tested
- rhBMP-2
- Medical subject headings
- Pseudarthrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhBMP-2Device
| Study group | Role | What they receive |
|---|---|---|
| Autologous bone grafting | Active comparator | autologous bone of the iliac crest Receives: Device: rhBMP-2 |
| rhBMP-2 | Experimental | Inductos, recombinant human bone morphogenetic protein Receives: Device: rhBMP-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone healing in the docking site
Measured: up to 4 months
Secondary outcomes (3)
Infection
Measured: up to one year
Edema
Measured: up to one year
cancer
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2012 (estimated)
- Study startJul 2015
- Primary completionJan 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PseudarthrosisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jan Vanderstappen, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756144
- Sponsor's protocol ID
- 2012-005664-10
- Status last verified
- May 2015
- First submitted
- 12 Dec 2012
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport
- ClinicalTrials.gov ID
- NCT01756144
- Acronym / sponsor ID
- 2012-005664-10
- Conditions
- Pseudarthrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 25 Dec 2012 (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.
When there is a bone defect, bone transport is used to bridge the defect. Frequently, the bone in the docking site (where the transported bone comes together) doesn't heal.
The objective is to study the effectivity of rhBmp-2 (inductos) to stimulate bone healing, in order to find new techniques to treat non-union of long bones.
The method of the study is a randomized controlled trial, to compare rhBMP-2 and autologous bone grafting in stimulating bone healing in the docking site.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous bone grafting | Active comparator | Device: rhBMP-2autologous bone of the iliac crest |
| rhBMP-2 | Experimental | Device: rhBMP-2Inductos, recombinant human bone morphogenetic protein |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients treated with bone transport (Ilizarov technique) and have non-union of the docking site, which is characterized by absence of bridging callus after two months of compression in the docking site.
Key exclusion criteria (6 listed)
- Allergy for inductos
- active growth,
- malignancy
- infection
- PAD
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 |
|---|---|---|
| rhBMP-2 | Device | Autologous bone grafting, rhBMP-2 |
Primary outcome
Bone healing in the docking site
Time frame: up to 4 months
3 secondary outcomes
Infection
Time frame: up to one year
Edema
Time frame: up to one year
cancer
Time frame: up to one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
Related trials for Pseudarthrosis
Recruiting
Diagnostic Interest of Bone Tomoscintigraphy in the Search for Cervical Pseudarthrosis
Cervical Pseudarthrosis
Active, not recruiting
Lumbar Fusion With Porous Versus Non-Porous Cages
Spinal Fusion, Lumbar Fusion
Recruiting
SPECT/CT Bone Scan Quantification Surgery
Pseudoarthrosis of Bone
Active, not recruitingObservational study
Collecting Bone Graft During Spinal Decompression and Posterolateral Lumbar Fusion to Better Define Bone Making Cells
Pseudarthrosis After Fusion or Arthrodesis
RecruitingPhase 3
A Study to Assess How Effective and Safe NVD003 is for Treating Patients With Congenital Pseudarthrosis of the Tibia.
Congenital Pseudarthrosis of Tibia
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing rhBMP-2 in people with Pseudarthrosis, run by Universitaire Ziekenhuizen KU Leuven.
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 6 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: status not confirmed, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Bone healing in the docking site (time frame: up to 4 months). It is what the study was designed to measure, not a finding.
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 28 May 2015.