A Prospective Randomized Controlled Trial on the Use of Bone Morphogenetic 7 (BMP-7) (OP-1®) and Demineralized Bone Matrix in Tibial Non-union
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 2 non-union of diaphysary tibial fractures will be treated with allograft together with DBM |
Procedure: allograft together with DBM
non-union of diaphysary tibial fractures treated with allograft together with DBM
|
| Experimental: 1 non-union of diaphysary tibial fractures will be treated with BMP-7 in adjunct to fresh frozen allograft |
Procedure: BMP-7 in adjunct to fresh frozen allograft
non-union of diaphysary tibial fractures treated with BMP-7 in adjunct to fresh frozen allograft
|
Outcome Measures
Primary Outcome Measures
- X-ray evaluation [After 9 months]
- Change in VAS and LEFS scores [After 9 months]
Secondary Outcome Measures
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AZ Sint Jan-Brugge | Brugge | Belgium | ||
| 2 | University Hospital Ghent | Ghent | Belgium | 9000 |
Sponsors and Collaborators
- University Hospital, Ghent
Investigators
- Principal Investigator: Rene Verdonk, MD, PhD, University Hospital, Ghent
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2007/341