Non-union Diaphysary Tibial Fractures
Conditions
Brief 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 allograft together with DBM (demineralised bone matrix).
Interventions
PROCEDUREBMP-7 in adjunct to fresh frozen allograft
non-union of diaphysary tibial fractures treated with BMP-7 in adjunct to fresh frozen allograft
PROCEDUREallograft together with DBM
non-union of diaphysary tibial fractures treated with allograft together with DBM
Sponsors
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| X-ray evaluation | After 9 months |
| Change in VAS and LEFS scores | After 9 months |
Secondary
| Measure | Time frame |
|---|---|
| Total socio-economic cost estimation | After 4 years |
| Repeated surgery (minor and major) | After 4 years |
| Time of incapacity to work | Until ability to work |
| Ability to bear weight (% of body weight) | After 4 years |
| (Surgical) complications | After 4 years |
| Change in SF-36 | After 4 years |
Countries
Belgium
Outcome results
None listed