Safety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures Requiring Grafting

PHASE2CompletedINTERVENTIONAL
Enrollment

208

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

September 30, 2011

Study Completion Date

September 30, 2011

Conditions
Tibia Plateau Fractures
Interventions
DRUG

I-0401 (a new bone graft substitute)

1 time application

Trial Locations (45)

1011

CHUV Lausanne (02), Lausanne

1041

Fövarosi Önkormanyzat Karolyi Sandor Korhaz es Rendelointezet (21), Budapest

1081

Fövarosi Önkormanyzat Peterfy Sandor utcai Korhaz-Rendelöinezet es Baleseti Központ (20), Budapest

1125

Fovárosi Önkormányzat Szent János Kórháza és Észak (54), Budapest

4031

Universitätsspital Basel (24), Basel

4101

Kantonsspital Bruderholz (25), Bruderholz

4102

Princess Alexandra Hospital (45), Woollongabba

4215

Gold Coast Hospital (49), Gold Coast

5000

Royal Adelaide Hospital (48), Adelaide

6000

Kantonsspital Luzern (26), Lucerne

6725

Szegedi Egyetem AOK Kari Gyogyszertar (27), Szeged

8091

Zurich University Hospital (01), Zurich

9024

Petz Alandar County Teaching Hospital (55), Győr

13353

Charite, Campus Virchow Klinikum (03), Berlin

16132

A.O. Universitaria San Martino (33), Genova

24105

Universitätsklinikum Schleswig-Holstein (40), Kiel

28006

Hospital Universitario de la Princesa (18), Madrid

28220

Hospital FREMAP Majadahonda (17), Madrid

29010

Hospital Universitario Virgen de la Victoria (51), Málaga

29200

Hopital La Cavale Blanche (19), Brest

30625

Med. Hochschule Hannover (06), Hanover

37075

Uniklinik Göttingen (22), Göttingen

40136

Istituti Ortopedici Rizzoli (13), Bologna

41012

Hospital FREMAP Sevilla (32), Seville

41940

SPZOZ Wojewodzki - Specjalistyczny Szpital Chirurgii Urazowej (35), Piekary Śląskie

46009

Hospital Universitario La Fe (07), Valencia

47249

Berufsgenossenschaftliche Unfallklinik Bochum/Duisburg (11), Duisburg

48149

Universitätsklinikum Münster (39), Münster

52441

St.-Josef-Krankenhaus (12), Linnich

54000

Hôpital Central de Nancy (05), Nancy

59380

Hôpital de Dunkerque (30), Dunkirk

71252

Katedra i Klinika Ortopedii - Traumatologii PAM (34), Szczecin

76031

Hôpital Charles Nicolle (15), Rouen

81366

Chirurgische Klinik der LMU (50), München

90015

Fondazione Istituto San Raffaele G. Giglio di Cefalù (16), Cefalù

00133

"Università degli Studi di Roma Tor Vergata (10)", Roma

00184

A.O. San Giovanni Oddolorata (14), Roma

31-826

Klinika i Oddzial Kliniczny - Ortopedii i Traumatologii (36), Krakow

93-513

Oddzial Chirurgii Ortopedyczno-Urazowej - Wojewodzki Szpital Specjalistyczny (58), Lodz

00-909

Wojskowy Instytut Medyczny - Centralny Szpital Kliniczny MON (60), Warsaw

02005

Katedra I Klinika Ortopedii AM (29), Warsaw

LS1 3EX

Leeds General Infirmary (04), Leeds

BS16 1LE

N. Bristol NHS Trust + Univ. of Bristol (52), Bristol

CF14 4XW

University Hospital of Wales (31), Cardiff

NR4 7UY

Norfolk and Norwich University Hospital (44), Norwich

Sponsors
All Listed Sponsors
lead

Kuros Biosurgery AG

INDUSTRY

NCT00409799 - Safety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures Requiring Grafting | Biotech Hunter | Biotech Hunter