A prospective randomised controlled trial on the use of BMP-7 (Bone Morphogenetic Protein-7) (OP-1®) and demineralised bone matrix (DBM) in tibial non-union.

niversity Hospital Ghent0 个研究点目标入组 30 人开始时间: 2007年9月12日最近更新: 2015年8月17日

适应症

试验速览

暂无简介。

•Diaphysary tibial non-unions will be included (9 months after first surgery)
•ASA 1 and ASA 2
•Gap length/bone contact detected (cms) (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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•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

发起方

niversity Hospital Ghent