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A Prospective, Randomized, Multi-Center, Pilot Study of Osigraft on distraction osteogenesis : OSIGRAFT VS STANDARD TREATMENT

A Prospective, Randomized, Multi-Center, Pilot Study of Osigraft on distraction osteogenesis : OSIGRAFT VS STANDARD TREATMENT

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-004284-36-IT
Enrollment
Unknown
Registered
2005-09-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Treatment in distraction osteogenesis on tibial diaphysis osteotomy site because of previous resection for non-union, infection, trauma, or for reasons not linked to resection (i.e. aesthetics)of at least 3 cm. MedDRA version: 6.1 Level: SOC Classification code 10028395

Interventions

Trade Name: OSIGRAFT*1 FL 1 G Product Name: NA Product Code: NA Pharmaceutical Form: Implant INN or Proposed INN: VARI Concentration unit: g gram(s) Concentration type: equal Concentration number: 1-

Sponsors

AOU CAREGGI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Italy

Outcome results

None listed

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