A prospective randomised controlled trial on the use of BMP-7 (Bone Morphogenetic Protein-7) (OP-1®) and demineralised bone matrix (DBM) in tibial non-union.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006727-39-BE

Enrollment

Registered

2007-09-12

Start date

2007-10-18

Completion date

Unknown

Last updated

2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-union of the diaphysis of the tibia

Interventions

Trade Name: Osigraft Product Name: OP-1 Pharmaceutical Form: Powder for implantation suspension INN or Proposed INN: eptotermin alfa CAS Number: 129805-33-0 Concentration unit: mg milligram(s) Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Diaphysary tibial non-unions will be included (9 months after first surgery) • ASA 1 and ASA 2 • Gap length/bone contact detected (cms) (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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the clinical and radiological outcome of tibial diaphysary non-unions in patients surgically treated with adjunct use of BMP-7 compared to the adjunct use of demineralized bone matrix (DBM). ;Secondary Objective: To investigate the effect of surgical treatment of non-union of tibial fractures with BMP-7 or DBM on quality of life and to investigate the socio-economic implications. ;Primary end point(s): X-ray evaluation at 9 months Change in VAS and LEFS scores at 9 months	—

Measure

Time frame

Main Objective: To investigate the clinical and radiological outcome of tibial diaphysary non-unions in patients surgically treated with adjunct use of BMP-7 compared to the adjunct use of demineralized bone matrix (DBM). ;Secondary Objective: To investigate the effect of surgical treatment of non-union of tibial fractures with BMP-7 or DBM on quality of life and to investigate the socio-economic implications. ;Primary end point(s): X-ray evaluation at 9 months Change in VAS and LEFS scores at 9 months

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026