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

University Hospital, Ghent2 sites in 1 country2 target enrollmentOctober 2007

ConditionsNon-union Diaphysary Tibial Fractures

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Non-union Diaphysary Tibial Fractures
Sponsor: University Hospital, Ghent
Enrollment: 2
Locations: 2
Primary Endpoint: Change in VAS and LEFS scores
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

July 9, 2012

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Ghent

Responsible Party

Sponsor

Eligibility Criteria

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