- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00533793
Adjunctive Therapy to Treat Tibial Shaft Fractures (TSF)
March 15, 2012 updated by: Kuros Biosurgery AG
A Phase II Randomized, Controlled, Open-labeled (Dose-blinded) Dose Finding Study of the Safety and Efficacy of I-040202 in the Treatment of Patients With Acute Open Tibial Shaft Fractures
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
201
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Plovdiv, Bulgaria, 4002
- MHAT ''Sveti Georgi'', Orthopaedic and Traumatology clinic (85)
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Sofia, Bulgaria, 1606
- MHATEM ''N.I.Pirogov'' Second clinic of Orthopaedic and Traumatology (84)
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Brno, Czech Republic, 662 50
- Czech Republic (51)
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Praha, Czech Republic, 150 06
- Czech Republic (52)
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Kuopio, Finland, 70211
- Finland (71)
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Oulu, Finland, 90220
- Finland (72)
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Turku, Finland, 20520
- Finland (70)
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Dijon Cedex, France, 21079
- France (14)
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Dunkerque, France, 59240
- France (16)
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Limoges Cedex, France, 87042
- France (15)
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Rouen cedex, France, 76031
- France (11)
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Göttingen, Germany, 37075
- Germany (50)
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Kiel, Germany, 24105
- Germany (43)
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Leipzig, Germany, 04103
- Germany (40)
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Ludwigshafen, Germany, 67071
- Germany (41)
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München, Germany, 81377
- Germany (44)
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Ravensburg, Germany, 88212
- Germany (42)
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Rostock, Germany, 18057
- Germany (45)
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Budapest, Hungary, 1125
- Fovarosi Onkormanyzat Szent janos Korhaza (81)
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Debrecen, Hungary, 4031
- Hungary (54)
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Esztergom, Hungary, 2500
- Vaszary Kolos Hospital Esztergom (78)
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Kaposvar, Hungary, 7500
- Hungary (79)
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Nyiregyhaza, Hungary, 4400
- Hungary (55)
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Pecs, Hungary, 7632
- Hungary (53)
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Rozzano, Italy, 20089
- Italy (21)
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Bucharest, Romania, 014461
- Romania (59)
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Bucharest, Romania, 041915
- Romania (58)
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Bucharest, Romania, 050098
- Spitalul Universitar de Urgenta Bucuresti (87)
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Cluj Napoca, Romania, 400132
- Romania (57)
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Constanta, Romania, 900591
- Spitalul Clinic Judetean Constanta (88)
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Oradea, Romania, 410032
- Romania (73)
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Sibiu, Romania, 550245
- Romania (74)
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Timisoara, Romania, 300736
- Romania (56)
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Belgrade, Serbia, 11000
- Serbia (60)
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Belgrade, Serbia, 11000
- Serbia (76)
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Belgrade, Serbia, 11080
- Serbia (61)
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Kragujevac, Serbia, 34000
- Serbia (62)
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Novi Sad, Serbia, 21000
- Serbia (75)
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Banska Bysterica, Slovakia, 975 17
- Slovak Republic (65)
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Bratislava 2, Slovakia, 833 05
- Slovak Republic (64)
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Trnava, Slovakia, 917 75
- Slovak Republic (77)
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Zilina, Slovakia, 012 07
- Slovak Republic (63)
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Izola, Slovenia, 6310
- Slovenia (67)
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Novo mesto, Slovenia, 8000
- Slovenia (66)
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Aarau, Switzerland, 5001
- Switzerland (02)
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Davos, Switzerland, 7270
- Switzerland (03)
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Lausanne, Switzerland, 1011
- Switzerland (01)
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Luzern, Switzerland, 6000
- Switzerland (04)
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St. Gallen, Switzerland, 9007
- Switzerland (05)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Eligible patients must meet all of the following inclusion criteria:
- 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
- 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
- male and female patients >= 18 years
- body mass index (BMI) 16-33 (minimum body weight 50 kg, maximum 140 kg)
- females of child-bearing potential must be willing to undergo a pregnancy test (urine) prior to treatment start (at screening)
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
- willingness and ability to understand, participate and comply with the study requirements
- 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 exclusion criteria:
- IIIc open fracture according to the Gustilo-Anderson classification
- tibial defects requiring bone-grafting (e.g. large segmental defects)
- duration from trauma to surgery longer than 14 days
- concomitant acute bone injuries and/or major skin or other significant injuries that in the opinion of the investigator would interfere with the tibial shaft fracture healing process
- concomitant ipsilateral tibial fractures other than in the diaphyseal region
- evidence of immune suppression
- suspected or known hypersensitivity to the study medication or components of it
- evidence of hypercalcemia
- hyperparathyroidism
- on treatment and/or planned treatment with products containing PTH (e.g. Forteo)
- pregnant or lactating females
- participation in another clinical trial within the last 3 months
- active or past history of malignant tumor
- history or evidence for any hereditary or acquired chronic metabolic bone disease other than primary osteoporosis.
- history or evidence for any clinically relevant organ failure or any other relevant medical condition that, in the opinion of the investigator, will relevantly interfere with the assessment of study outcome or will impose hazard to the patient if study therapy will be initiated
- known history of allergy to anaesthetics
- evidence of moderate or severe renal failure (serum creatinine > 3.0 times ULN, NCI CTC grades 3 and 4)
- known history of allergic thrombocytopenia (type II) induced by heparin
- inexplicable elevations of alkaline phosphatase or alkaline phosphatase > 5.0 times ULN, NCI CTC grades 3 and 4
- prior external beam or implant radiation therapy to the skeleton
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: SoC
Standard of Care
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internal fracture fixation: osteosynthesis plates or intra-medullary nails
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Active Comparator: SoC plus 0.133 mg/mL
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internal fracture fixation: osteosynthesis plates or intra-medullary nails
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Active Comparator: SoC plus 0.4 mg/mL
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internal fracture fixation: osteosynthesis plates or intra-medullary nails
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Active Comparator: SoC plus 1.0 mg/mL
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internal fracture fixation: osteosynthesis plates or intra-medullary nails
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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)
Time Frame: short term follow-up: 6 months; long term follow-up: additional 6 months (total duration of 1 year)
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short term follow-up: 6 months; long term follow-up: additional 6 months (total duration of 1 year)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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.
Time Frame: short term follow-up: 6 months; long term follow-up: additional 6 months (1 year)
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short term follow-up: 6 months; long term follow-up: additional 6 months (1 year)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
May 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
September 20, 2007
First Submitted That Met QC Criteria
September 20, 2007
First Posted (Estimate)
September 21, 2007
Study Record Updates
Last Update Posted (Estimate)
March 16, 2012
Last Update Submitted That Met QC Criteria
March 15, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS I-040202/01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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