Non-union Diaphysary Tibial FracturesPhase 4NCT00551941
A Prospective Randomized Controlled Trial on the Use of Bone Morphogenetic 7 (BMP-7) (OP-1®) and Demineralized Bone Matrix in Tibial Non-union
A Phase 4 study testing BMP-7 in adjunct to fresh frozen allograft and allograft together with DBM in people with Non-union Diaphysary Tibial Fractures, run by University Hospital, Ghent at 2 sites in Belgium.
Trial summary
The researchers propose a prospective, randomised partially-blinded study to investigate the clinical and radiological outcome, effect on quality of life and socio-economic impact of non-union of diaphysary tibial fractures treated with BMP-7 in adjunct to fresh frozen allograft, in comparison to treatment with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-union Diaphysary Tibial Fractures
- What is being tested?
- BMP-7 in adjunct to fresh frozen allograft and allograft together with DBM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesBelgium
- Study dates
- Oct 2007to 9 Jul 2012
- 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
- Diaphysary tibial non-unions will be included (9 months after first surgery)
- Major surgery includes exchange nailing, bone grafting, internal fixation, amputation and soft-tissue coverage procedures, such as delayed primary closure and free flaps
- Surgery is classified as minor for removal of external fixator pins for local infection and removal of a static locking screw from intramedullary nails, a procedure known as dynamization
- ASA 1 and ASA 2
- Gap length/bone contact detected (1-5 cm): largest cortical gap in any radiographic incidence
- Subject or legal guardian is willing and able to understand, sign and date the study specific Patient Informed Consent, which has been approved by the Institutional Review Board
- Agrees to participate in post-operative evaluations and required rehabilitation regimen
Who cannot join
- Patients with known hypersensitivity to the active substance or collagen
- Gap more than 5 cm
- Immature skeleton
- Known auto-immune disease, including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome and dermatomyositis/polymyositis
- Active infection on unhealed site or active systemic infection
- Non-healing resulting from pathological fractures, tumours or metabolic bone diseases
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- Presence of tumour in vicinity of non-union
- Patients receiving chemotherapy, radiotherapy or immunosuppressant treatment or excessive steroids
- Patients with severely compromised soft tissue coverage or vascularisation at the non-union site, sufficient to impair bone healing
- Patients with congenital non-union
- Pregnancy and lactation
- Non-union of multiple bones interfering with walking
- Patients with neuromuscular diseases or conditions interfering normal weight bearing
- Patients who, judged by the surgeon, are candidates for just internal fixation alone
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Prospective Randomised Controlled Trial on the Use of BMP-7 (OP-1®) and Demineralised Bone Matrix in Tibial Non-union
The researchers propose a prospective, randomised partially-blinded study to investigate the clinical and radiological outcome, effect on quality of life and socio-economic impact of non-union of diaphysary tibial fractures treated with BMP-7 in adjunct to fresh frozen allograft, in comparison to treatment with allograft together with DBM (demineralised bone matrix).
- Conditions
- Non-union Diaphysary Tibial Fractures
- Being tested
- BMP-7 in adjunct to fresh frozen allograft, allograft together with DBM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMP-7 in adjunct to fresh frozen allograftProcedure or surgery
non-union of diaphysary tibial fractures treated with BMP-7 in adjunct to fresh frozen allograft
allograft together with DBMProcedure or surgery
non-union of diaphysary tibial fractures treated with allograft together with DBM
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | non-union of diaphysary tibial fractures will be treated with allograft together with DBM Receives: Procedure: allograft together with DBM |
| 1 | Experimental | non-union of diaphysary tibial fractures will be treated with BMP-7 in adjunct to fresh frozen allograft Receives: Procedure: BMP-7 in adjunct to fresh frozen allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
X-ray evaluation
Measured: After 9 months
Change in VAS and LEFS scores
Measured: After 9 months
Secondary outcomes (6)
Time of incapacity to work
Measured: Until ability to work
Change in SF-36
Measured: After 4 years
Total socio-economic cost estimation
Measured: After 4 years
Repeated surgery (minor and major)
Measured: After 4 years
(Surgical) complications
Measured: After 4 years
Ability to bear weight (% of body weight)
Measured: After 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2007 (estimated)
- Study startOct 2007
- Primary completion9 Jul 2012
- Study completion9 Jul 2012
Why it stopped: Recruitment problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-union Diaphysary Tibial FracturesStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rene Verdonk, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551941
- Sponsor's protocol ID
- 2007/341
- Status last verified
- Jul 2021
- First submitted
- 30 Oct 2007
- Last updated
- 8 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Controlled Trial on the Use of BMP-7 (OP-1®) and Demineralised Bone Matrix in Tibial Non-union
- ClinicalTrials.gov ID
- NCT00551941
- Acronym / sponsor ID
- 2007/341
- Conditions
- Non-union Diaphysary Tibial Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment problems
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Oct 2007 (actual)
- Primary completion
- 9 Jul 2012 (actual)
- Study completion
- 9 Jul 2012 (actual)
- First posted
- 1 Nov 2007 (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 researchers propose a prospective, randomised partially-blinded study to investigate the clinical and radiological outcome, effect on quality of life and socio-economic impact of non-union of diaphysary tibial fractures treated with BMP-7 in adjunct to fresh frozen allograft, in comparison to treatment with allograft together with DBM (demineralised bone matrix).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Procedure: allograft together with DBMnon-union of diaphysary tibial fractures will be treated with allograft together with DBM |
| 1 | Experimental | Procedure: BMP-7 in adjunct to fresh frozen allograftnon-union of diaphysary tibial fractures will be treated with BMP-7 in adjunct to fresh frozen allograft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diaphysary tibial non-unions will be included (9 months after first surgery)
- Major surgery includes exchange nailing, bone grafting, internal fixation, amputation and soft-tissue coverage procedures, such as delayed primary closure and free flaps
- Surgery is classified as minor for removal of external fixator pins for local infection and removal of a static locking screw from intramedullary nails, a procedure known as dynamization
- ASA 1 and ASA 2
- Gap length/bone contact detected (1-5 cm): largest cortical gap in any radiographic incidence
Key exclusion criteria (14 listed)
- Patients with known hypersensitivity to the active substance or collagen
- Gap more than 5 cm
- Immature skeleton
- Known auto-immune disease, including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome and dermatomyositis/polymyositis
- Active infection on unhealed site or active systemic infection
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 |
|---|---|---|
| BMP-7 in adjunct to fresh frozen allograftnon-union of diaphysary tibial fractures treated with BMP-7 in adjunct to fresh frozen allograft | Procedure or surgery | 1 |
| allograft together with DBMnon-union of diaphysary tibial fractures treated with allograft together with DBM | Procedure or surgery | 2 |
Primary outcome
X-ray evaluation
Time frame: After 9 months
Change in VAS and LEFS scores
Time frame: After 9 months
6 secondary outcomes
Time of incapacity to work
Time frame: Until ability to work
Change in SF-36
Time frame: After 4 years
Total socio-economic cost estimation
Time frame: After 4 years
Repeated surgery (minor and major)
Time frame: After 4 years
(Surgical) complications
Time frame: After 4 years
Ability to bear weight (% of body weight)
Time frame: After 4 years
Results and safety
The study was stopped early (reason given: Recruitment problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
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.
Rene Verdonk, MD, PhD principal investigator
University Hospital, Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BMP-7 in adjunct to fresh frozen allograft and allograft together with DBM in people with Non-union Diaphysary Tibial Fractures, run by University Hospital, Ghent at 2 sites in Belgium.
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 7 inclusion and 14 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: stopped early, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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 was stopped early (reason given: Recruitment problems). 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?
X-ray evaluation (time frame: After 9 months). The study lists 2 primary outcomes in all. 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 8 Jul 2021.