Clinical trial NCT00551941: A Prospective Randomized Controlled Trial on the Use of Bone Morphogenetic 7 (BMP-7) (OP-1®) and Demineralized Bone Matrix in Tibial Non-union
Official title: A Prospective Randomised Controlled Trial on the Use of BMP-7 (OP-1®) and Demineralised Bone Matrix in Tibial Non-union
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Non-union Diaphysary Tibial Fractures
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2007-11-01
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: X-ray evaluation
timeFrame: After 9 months
measure: Change in VAS and LEFS scores
timeFrame: After 9 months
Secondary outcomes:
measure: Time of incapacity to work
timeFrame: Until ability to work
measure: Change in SF-36
timeFrame: After 4 years
measure: Total socio-economic cost estimation
timeFrame: After 4 years
measure: Repeated surgery (minor and major)
timeFrame: After 4 years
measure: (Surgical) complications
timeFrame: After 4 years
measure: Ability to bear weight (% of body weight)
timeFrame: After 4 years
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: AZ Sint Jan-Brugge
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Rene Verdonk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: