Status:
COMPLETED
Safety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures Requiring Grafting
Lead Sponsor:
Kuros Biosurgery AG
Conditions:
Tibia Plateau Fractures
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
For certain tibial plateau fractures the bone is compressed due to the force acting on the tibia during the accident. The void provoked by the compression of the bone is filled with an appropriate fil...
Eligibility Criteria
Inclusion
- Radiological evidence of a tibial plateau fracture requiring grafting
- Females of child-bearing potential must be willing to undergo a pregnancy test (urine) prior to treatment start (at screening).
Exclusion
- Concomitant ipsilateral fractures of the limb other than the fracture of the tibial plateau.
- Active or past history of malignant tumor.
- Evidence of systemic or localized infection at time of surgery.
- Pregnant or lactating females.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT00409799
Start Date
November 1 2006
End Date
September 1 2011
Last Update
March 16 2012
Active Locations (45)
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1
Gold Coast Hospital (49)
Gold Coast, Queensland, Australia, 4215
2
Princess Alexandra Hospital (45)
Woollongabba, Queensland, Australia, 4102
3
Royal Adelaide Hospital (48)
Adelaide, South Australia, Australia, 5000
4
Hopital La Cavale Blanche (19)
Brest, France, 29200