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

Phase 4

Terminated

• Conditions: Non-union Diaphysary Tibial Fractures
• Interventions: Procedure: allograft together with DBM; Procedure: BMP-7 in adjunct to fresh frozen allograft

• Registration Number: NCT00551941
• Lead Sponsor: University Hospital, Ghent

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-30
• Study First Submitted QC: 2007-10-31
• Study First Posted: 2007-11-01
• Primary Completion: 2012-07-09
• Study Completion: 2012-07-09
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-07
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	allograft together with DBM	non-union of diaphysary tibial fractures will be treated with allograft together with DBM
1	BMP-7 in adjunct to fresh frozen allograft	non-union of diaphysary tibial fractures will be treated with BMP-7 in adjunct to fresh frozen allograft

Primary Outcome Measures

Name	Time	Method
Change in VAS and LEFS scores	After 9 months
X-ray evaluation	After 9 months

Secondary Outcome Measures

Name	Time	Method
Time of incapacity to work	Until ability to work
Change in SF-36	After 4 years
Total socio-economic cost estimation	After 4 years
Repeated surgery (minor and major)	After 4 years
(Surgical) complications	After 4 years
Ability to bear weight (% of body weight)	After 4 years

Trial Locations

Locations (2)

University Hospital Ghent; 🇧🇪 Ghent, Belgium

AZ Sint Jan-Brugge; 🇧🇪 Brugge, Belgium