| Eligibility |
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
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