A Prospective Randomized Controlled Trial on the Use of Bone Morphogenetic 7 (BMP-7) (OP-1®) and Demineralized Bone Matrix in Tibial Non-union

Ghent University Hospital (UZ)

Status and phase

Terminated

Phase 4

Conditions

Non-union Diaphysary Tibial Fractures

Treatments

Procedure: allograft together with DBM

Procedure: BMP-7 in adjunct to fresh frozen allograft

Study type

Interventional

Funder types

Other

Identifiers

NCT00551941

2007/341

Details and patient eligibility

About

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).

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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