Adjunctive Therapy to Treat Tibial Shaft Fractures (TSF)
15. mars 2012 oppdatert av: 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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
201
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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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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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, Frankrike, 21079
- France (14)
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Dunkerque, Frankrike, 59240
- France (16)
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Limoges Cedex, Frankrike, 87042
- France (15)
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Rouen cedex, Frankrike, 76031
- France (11)
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Rozzano, Italia, 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, Sveits, 5001
- Switzerland (02)
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Davos, Sveits, 7270
- Switzerland (03)
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Lausanne, Sveits, 1011
- Switzerland (01)
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Luzern, Sveits, 6000
- Switzerland (04)
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St. Gallen, Sveits, 9007
- Switzerland (05)
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Brno, Tsjekkisk Republikk, 662 50
- Czech Republic (51)
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Praha, Tsjekkisk Republikk, 150 06
- Czech Republic (52)
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Göttingen, Tyskland, 37075
- Germany (50)
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Kiel, Tyskland, 24105
- Germany (43)
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Leipzig, Tyskland, 04103
- Germany (40)
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Ludwigshafen, Tyskland, 67071
- Germany (41)
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München, Tyskland, 81377
- Germany (44)
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Ravensburg, Tyskland, 88212
- Germany (42)
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Rostock, Tyskland, 18057
- Germany (45)
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Budapest, Ungarn, 1125
- Fovarosi Onkormanyzat Szent janos Korhaza (81)
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Debrecen, Ungarn, 4031
- Hungary (54)
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Esztergom, Ungarn, 2500
- Vaszary Kolos Hospital Esztergom (78)
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Kaposvar, Ungarn, 7500
- Hungary (79)
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Nyiregyhaza, Ungarn, 4400
- Hungary (55)
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Pecs, Ungarn, 7632
- Hungary (53)
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: SoC
Velferdstandard
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internal fracture fixation: osteosynthesis plates or intra-medullary nails
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Aktiv komparator: SoC plus 0.133 mg/mL
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internal fracture fixation: osteosynthesis plates or intra-medullary nails
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Aktiv komparator: SoC plus 0.4 mg/mL
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internal fracture fixation: osteosynthesis plates or intra-medullary nails
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Aktiv komparator: SoC plus 1.0 mg/mL
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internal fracture fixation: osteosynthesis plates or intra-medullary nails
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
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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.
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2007
Primær fullføring (Faktiske)
1. mai 2011
Studiet fullført (Faktiske)
1. mai 2011
Datoer for studieregistrering
Først innsendt
20. september 2007
Først innsendt som oppfylte QC-kriteriene
20. september 2007
Først lagt ut (Anslag)
21. september 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
16. mars 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. mars 2012
Sist bekreftet
1. mars 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CS I-040202/01
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