Trauma
Conditions
Keywords
bone, tibial shaft fracture
Brief summary
A phase 2, prospective, randomized, controlled, open-label (dose-blinded), parallel group, international multi-center study. The study will consist of four treatment groups - one control group (SoC) and three I-040202 groups receiving SoC plus 0.133 mg/mL, 0.4 mg/mL or 1.0 mg/mL I-040202.
Interventions
PROCEDUREopen fracture reduction
internal fracture fixation: osteosynthesis plates or intra-medullary nails
Sponsors
Baxter BioScience
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
Eligible patients must meet all of the following inclusion criteria: 1. patients with an acute open fracture of the tibial shaft secondary to trauma assessed by medical examination and current radiographs indicated for open fracture reduction and internal fixation using osteosynthesis plates or intra-medullary nails 2. soft tissue management (if medically warranted, eg. debridement, irrigation, application of antibiotics) performed according to local hospital practice no later than 24h after the trauma 3. male and female patients \>= 18 years 4. body mass index (BMI) 16-33 (minimum body weight 50 kg, maximum 140 kg) 5. females of child-bearing potential must be willing to undergo a pregnancy test (urine) prior to treatment start (at screening) 6. females of child-bearing potential randomized in the intervention group must agree to have acceptable contraception for at least 3 months after receiving the study medication. Acceptable contraceptive measures are: * Hormonal types of birth control with a failure rate of less than 1% per year (such as implants, injections, combined oral contraceptives, patches or other methods) or copper IUDs or other IUDs with a failure rate of less than 1% per year, AND * An additional barrier type of birth control measure (such as condoms, diaphragms, cervical caps, etc.) Sterilized women and abstinent women of child-bearing potential will not be required to take contraceptive measures 7. willingness and ability to understand, participate and comply with the study requirements 8. patient be able to give consent personally and sign the Informed Consent Form.
Exclusion criteria
Patients will be not eligible if they meet one of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Criteria:weight bearing,red.pain,walking without aid;lack of need for surg. interv. fracture site;Radiogr. crit.:Cortical bridging,disintegration/disappearance fracture lines,absence of signs for complications(infection,malunion) | short term follow-up: 6 months; long term follow-up: additional 6 months (total duration of 1 year) |
Secondary
| Measure | Time frame |
|---|---|
| Prop. patients healed 3,9,12 mths after T0; prop. time, extent radiogr. union for 2,3,4,5,6,9,12 mths after T0; Eval.:6 and 12 mths; prop./invasiven. sec. interv. due to persistent non-union within 6,12 mths after T0. | short term follow-up: 6 months; long term follow-up: additional 6 months (1 year) |
Countries
Bulgaria, Czechia, Finland, France, Germany, Hungary, Italy, Romania, Serbia, Slovakia, Slovenia, Switzerland
Outcome results
None listed