Tibia Plateau Fractures Clinical Trial
Official title:
A Phase 2 Randomized, Controlled, Open-label (Dose-blinded), Multi-center, Dose-finding Study of the Safety and Efficacy of I-0401 in the Treatment of Patients With Fractures of the Tibial Plateau Requiring Grafting.
| Verified date | March 2012 |
| Source | Kuros Biosurgery AG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
For certain tibial plateau fractures the bone is compressed due to the force acting on the tibia during the accident. The void provoked by the compression of the bone is filled with an appropriate filling material and the fracture is fixated. I 0401 is a new bone graft substitute that has shown capacities to promote bone-healing. This study will test the safety and efficacy of I 0401 in the treatment of patients with tibial plateau fractures requiring grafting.
| Status | Completed |
| Enrollment | 208 |
| Est. completion date | September 2011 |
| Est. primary completion date | September 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Radiological evidence of a tibial plateau fracture requiring grafting - Females of child-bearing potential must be willing to undergo a pregnancy test (urine) prior to treatment start (at screening). Exclusion Criteria: - Concomitant ipsilateral fractures of the limb other than the fracture of the tibial plateau. - Active or past history of malignant tumor. - Evidence of systemic or localized infection at time of surgery. - Pregnant or lactating females. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Adelaide Hospital (48) | Adelaide | South Australia |
| Australia | Gold Coast Hospital (49) | Gold Coast | Queensland |
| Australia | Princess Alexandra Hospital (45) | Woollongabba | Queensland |
| France | Hopital La Cavale Blanche (19) | Brest | |
| France | Hôpital de Dunkerque (30) | Dunkerque | |
| France | Hôpital Central de Nancy (05) | Nancy | |
| France | Hôpital Charles Nicolle (15) | Rouen | |
| Germany | Charite, Campus Virchow Klinikum (03) | Berlin | |
| Germany | Berufsgenossenschaftliche Unfallklinik Bochum/Duisburg (11) | Duisburg | |
| Germany | Uniklinik Göttingen (22) | Göttingen | |
| Germany | Med. Hochschule Hannover (06) | Hannover | |
| Germany | Universitätsklinikum Schleswig-Holstein (40) | Kiel | |
| Germany | St.-Josef-Krankenhaus (12) | Linnich | |
| Germany | Chirurgische Klinik der LMU (50) | München | |
| Germany | Universitätsklinikum Münster (39) | Münster | |
| Hungary | 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) | Györ | |
| Hungary | Szegedi Egyetem AOK Kari Gyogyszertar (27) | Szeged | |
| Italy | 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 | A.O. San Giovanni Oddolorata (14) | Roma | |
| Italy | Università degli Studi di Roma "Tor Vergata" (10) | Roma | |
| Poland | 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 Slaskie | |
| 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) | Warszawa | |
| Spain | Hospital FREMAP Majadahonda (17) | Madrid | |
| Spain | Hospital Universitario de la Princesa (18) | Madrid | |
| Spain | Hospital Universitario Virgen de la Victoria (51) | Málaga | |
| Spain | Hospital FREMAP Sevilla (32) | Sevilla | |
| Spain | Hospital Universitario La Fe (07) | Valencia | |
| Switzerland | Universitätsspital Basel (24) | Basel | |
| Switzerland | Kantonsspital Bruderholz (25) | Bruderholz | |
| Switzerland | CHUV Lausanne (02) | Lausanne | |
| Switzerland | Kantonsspital Luzern (26) | Luzern | |
| Switzerland | Zurich University Hospital (01) | Zurich | Canton Zurich |
| United Kingdom | N. Bristol NHS Trust + Univ. of Bristol (52) | Bristol | |
| United Kingdom | University Hospital of Wales (31) | Cardiff | |
| United Kingdom | Leeds General Infirmary (04) | Leeds | West Yorkshire |
| United Kingdom | Norfolk and Norwich University Hospital (44) | Norwich |
| Lead Sponsor | Collaborator |
|---|---|
| Kuros Biosurgery AG |
Australia, France, Germany, Hungary, Italy, Poland, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Radiographic Images | All Follow-Up Visits | ||
| Secondary | Clinical assessments of the fracture site | All Follow-Up Visits | ||
| Secondary | Blood parameters | All Follow-Up Visits | ||
| Secondary | Vital signs | At several Follow-Up visits | ||
| Secondary | Questionnaires of Life | All Follow-Up Visits | ||
| Secondary | Pharmacoeconomic evaluation | All Follow-Up Visits |