Tibia Plateau Fractures
Conditions
Keywords
Bone graft substitute, Promotion of bone healing
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 filling material and the fracture is fixated. I 0401 is a new bone graft substitute that has shown capacities to promote bone-healing. This study will test the safety and efficacy of I 0401 in the treatment of patients with tibial plateau fractures requiring grafting.
Interventions
DRUGI-0401 (a new bone graft substitute)
1 time application
Sponsors
Kuros Biosurgery AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic Images | All Follow-Up Visits |
Secondary
| Measure | Time frame |
|---|---|
| Clinical assessments of the fracture site | All Follow-Up Visits |
| Blood parameters | All Follow-Up Visits |
| Vital signs | At several Follow-Up visits |
| Questionnaires of Life | All Follow-Up Visits |
| Pharmacoeconomic evaluation | All Follow-Up Visits |
Countries
Australia, France, Germany, Hungary, Italy, Poland, Spain, Switzerland, United Kingdom
Outcome results
None listed