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

NCT ID: NCT00551941

Last Updated: 2021-07-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2012-07-09

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).

Conditions

Non-union Diaphysary Tibial Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

2

non-union of diaphysary tibial fractures will be treated with allograft together with DBM

Group Type: ACTIVE_COMPARATOR

allograft together with DBM

Intervention Type: PROCEDURE

non-union of diaphysary tibial fractures treated with allograft together with DBM

1

non-union of diaphysary tibial fractures will be treated with BMP-7 in adjunct to fresh frozen allograft

Group Type: EXPERIMENTAL

BMP-7 in adjunct to fresh frozen allograft

Intervention Type: PROCEDURE

non-union of diaphysary tibial fractures treated with BMP-7 in adjunct to fresh frozen allograft

Interventions

BMP-7 in adjunct to fresh frozen allograft

non-union of diaphysary tibial fractures treated with BMP-7 in adjunct to fresh frozen allograft

Intervention Type: PROCEDURE

allograft together with DBM

non-union of diaphysary tibial fractures treated with allograft together with DBM

Intervention Type: PROCEDURE

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rene Verdonk, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

AZ Sint Jan-Brugge

Bruges, , Belgium

University Hospital Ghent

Ghent, , Belgium

Countries

Belgium

Other Identifiers

2007/341

Identifier Type: -

Identifier Source: org_study_id