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.

• Conditions: non-union of the diaphysis of the tibia

• Registration Number: EUCTR2006-006727-39-BE
• Lead Sponsor: niversity Hospital Ghent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-12
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the clinical and radiological outcome of tibial diaphysary non-unions in patients surgically treated with adjunct use of BMP-7 compared to the adjunct use of demineralized bone matrix (DBM).<br>;Secondary Objective: To investigate the effect of surgical treatment of non-union of tibial fractures with BMP-7 or DBM on quality of life and to investigate the socio-economic implications.<br>;Primary end point(s): X-ray evaluation at 9 months<br>Change in VAS and LEFS scores at 9 months