Safety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures Requiring Grafting
NCT ID: NCT00409799
Last Updated: 2012-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
208 participants
INTERVENTIONAL
2006-11-30
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Experimental - high dose
I-0401 (a new bone graft substitute)
1 time application
2
Experimental - low dose
I-0401 (a new bone graft substitute)
1 time application
3
Autograft
I-0401 (a new bone graft substitute)
1 time application
Interventions
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I-0401 (a new bone graft substitute)
1 time application
Eligibility Criteria
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Inclusion Criteria
* Females of child-bearing potential must be willing to undergo a pregnancy test (urine) prior to treatment start (at screening).
Exclusion Criteria
* Active or past history of malignant tumor.
* Evidence of systemic or localized infection at time of surgery.
* Pregnant or lactating females.
18 Years
ALL
No
Sponsors
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Kuros Biosurgery AG
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Messmer, MD
Role: PRINCIPAL_INVESTIGATOR
Zurich University Hospital, Zurich, Switzerland
Locations
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Gold Coast Hospital (49)
Gold Coast, Queensland, Australia
Princess Alexandra Hospital (45)
Woollongabba, Queensland, Australia
Royal Adelaide Hospital (48)
Adelaide, South Australia, Australia
Hopital La Cavale Blanche (19)
Brest, , France
Hôpital de Dunkerque (30)
Dunkirk, , France
Hôpital Central de Nancy (05)
Nancy, , France
Hôpital Charles Nicolle (15)
Rouen, , France
Charite, Campus Virchow Klinikum (03)
Berlin, , Germany
Berufsgenossenschaftliche Unfallklinik Bochum/Duisburg (11)
Duisburg, , Germany
Uniklinik Göttingen (22)
Göttingen, , Germany
Med. Hochschule Hannover (06)
Hanover, , Germany
Universitätsklinikum Schleswig-Holstein (40)
Kiel, , Germany
St.-Josef-Krankenhaus (12)
Linnich, , Germany
Chirurgische Klinik der LMU (50)
München, , Germany
Universitätsklinikum Münster (39)
Münster, , Germany
Fövarosi Önkormanyzat Karolyi Sandor Korhaz es Rendelointezet (21)
Budapest, , Hungary
Fövarosi Önkormanyzat Peterfy Sandor utcai Korhaz-Rendelöinezet es Baleseti Központ (20)
Budapest, , Hungary
Fovárosi Önkormányzat Szent János Kórháza és Észak (54)
Budapest, , Hungary
Petz Alandar County Teaching Hospital (55)
Győr, , Hungary
Szegedi Egyetem AOK Kari Gyogyszertar (27)
Szeged, , Hungary
Istituti Ortopedici Rizzoli (13)
Bologna, , Italy
Fondazione Istituto San Raffaele G. Giglio di Cefalù (16)
Cefalù, , Italy
A.O. Universitaria San Martino (33)
Genova, , Italy
Università degli Studi di Roma "Tor Vergata" (10)
Roma, , Italy
A.O. San Giovanni Oddolorata (14)
Roma, , Italy
Klinika i Oddzial Kliniczny - Ortopedii i Traumatologii (36)
Krakow, , Poland
Oddzial Chirurgii Ortopedyczno-Urazowej - Wojewodzki Szpital Specjalistyczny (58)
Lodz, , Poland
SPZOZ Wojewodzki - Specjalistyczny Szpital Chirurgii Urazowej (35)
Piekary Śląskie, , Poland
Katedra i Klinika Ortopedii - Traumatologii PAM (34)
Szczecin, , Poland
Wojskowy Instytut Medyczny - Centralny Szpital Kliniczny MON (60)
Warsaw, , Poland
Katedra I Klinika Ortopedii AM (29)
Warsaw, , Poland
Hospital Universitario de la Princesa (18)
Madrid, , Spain
Hospital FREMAP Majadahonda (17)
Madrid, , Spain
Hospital Universitario Virgen de la Victoria (51)
Málaga, , Spain
Hospital FREMAP Sevilla (32)
Seville, , Spain
Hospital Universitario La Fe (07)
Valencia, , Spain
Zurich University Hospital (01)
Zurich, Canton Zurich, Switzerland
Universitätsspital Basel (24)
Basel, , Switzerland
Kantonsspital Bruderholz (25)
Bruderholz, , Switzerland
CHUV Lausanne (02)
Lausanne, , Switzerland
Kantonsspital Luzern (26)
Lucerne, , Switzerland
Leeds General Infirmary (04)
Leeds, West Yorkshire, United Kingdom
N. Bristol NHS Trust + Univ. of Bristol (52)
Bristol, , United Kingdom
University Hospital of Wales (31)
Cardiff, , United Kingdom
Norfolk and Norwich University Hospital (44)
Norwich, , United Kingdom
Countries
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References
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Smith TO, Casey L, McNamara IR, Hing CB. Surgical fixation methods for tibial plateau fractures. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD009679. doi: 10.1002/14651858.CD009679.pub3.
Other Identifiers
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CS I-040101/02
Identifier Type: -
Identifier Source: org_study_id
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