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 Prospective Randomized Controlled Trial on the Use of Bone Morphogenetic 7 (BMP-7) (OP-1®) and Demineralized 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).
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