Clinical trial NCT00409799: Safety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures Requiring Grafting
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tibia Plateau Fractures
Keywords: Bone graft substitute
Promotion of bone healing
Lead sponsor: Kuros Biosurgery AG
Sponsor class: INDUSTRY
First posted: 2006-12-11
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Radiographic Images
timeFrame: All Follow-Up Visits
Secondary outcomes:
measure: Clinical assessments of the fracture site
timeFrame: All Follow-Up Visits
measure: Blood parameters
timeFrame: All Follow-Up Visits
measure: Vital signs
timeFrame: At several Follow-Up visits
measure: Questionnaires of Life
timeFrame: All Follow-Up Visits
measure: Pharmacoeconomic evaluation
timeFrame: All Follow-Up Visits
Other outcomes:
Locations:
city: Gold Coast
country: Australia
facility: Gold Coast Hospital (49)
state: Queensland
city: Woollongabba
country: Australia
facility: Princess Alexandra Hospital (45)
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital (48)
state: South Australia
city: Brest
country: France
facility: Hopital La Cavale Blanche (19)
city: Dunkerque
country: France
facility: Hôpital de Dunkerque (30)
city: Nancy
country: France
facility: Hôpital Central de Nancy (05)
city: Rouen
country: France
facility: Hôpital Charles Nicolle (15)
city: Berlin
country: Germany
facility: Charite, Campus Virchow Klinikum (03)
city: Duisburg
country: Germany
facility: Berufsgenossenschaftliche Unfallklinik Bochum/Duisburg (11)
city: Göttingen
country: Germany
facility: Uniklinik Göttingen (22)
city: Hannover
country: Germany
facility: Med. Hochschule Hannover (06)
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein (40)
city: Linnich
country: Germany
facility: St.-Josef-Krankenhaus (12)
city: München
country: Germany
facility: Chirurgische Klinik der LMU (50)
city: Münster
country: Germany
facility: Universitätsklinikum Münster (39)
city: Budapest
country: Hungary
facility: Fövarosi Önkormanyzat Karolyi Sandor Korhaz es Rendelointezet (21)
city: Budapest
country: Hungary
facility: Fövarosi Önkormanyzat Peterfy Sandor utcai Korhaz-Rendelöinezet es Baleseti Központ (20)
city: Budapest
country: Hungary
facility: Fovárosi Önkormányzat Szent János Kórháza és Észak (54)
city: Györ
country: Hungary
facility: Petz Alandar County Teaching Hospital (55)
city: Szeged
country: Hungary
facility: Szegedi Egyetem AOK Kari Gyogyszertar (27)
city: Bologna
country: Italy
facility: Istituti Ortopedici Rizzoli (13)
city: Cefalù
country: Italy
facility: Fondazione Istituto San Raffaele G. Giglio di Cefalù (16)
city: Genova
country: Italy
facility: A.O. Universitaria San Martino (33)
city: Roma
country: Italy
facility: Università degli Studi di Roma "Tor Vergata" (10)
city: Roma
country: Italy
facility: A.O. San Giovanni Oddolorata (14)
city: Krakow
country: Poland
facility: Klinika i Oddzial Kliniczny - Ortopedii i Traumatologii (36)
city: Lodz
country: Poland
facility: Oddzial Chirurgii Ortopedyczno-Urazowej - Wojewodzki Szpital Specjalistyczny (58)
city: Piekary Slaskie
country: Poland
facility: SPZOZ Wojewodzki - Specjalistyczny Szpital Chirurgii Urazowej (35)
city: Szczecin
country: Poland
facility: Katedra i Klinika Ortopedii - Traumatologii PAM (34)
city: Warsaw
country: Poland
facility: Wojskowy Instytut Medyczny - Centralny Szpital Kliniczny MON (60)
city: Warszawa
country: Poland
facility: Katedra I Klinika Ortopedii AM (29)
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa (18)
city: Madrid
country: Spain
facility: Hospital FREMAP Majadahonda (17)
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria (51)
city: Sevilla
country: Spain
facility: Hospital FREMAP Sevilla (32)
city: Valencia
country: Spain
facility: Hospital Universitario La Fe (07)
city: Zurich
country: Switzerland
facility: Zurich University Hospital (01)
state: Canton Zurich
city: Basel
country: Switzerland
facility: Universitätsspital Basel (24)
city: Bruderholz
country: Switzerland
facility: Kantonsspital Bruderholz (25)
city: Lausanne
country: Switzerland
facility: CHUV Lausanne (02)
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern (26)
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary (04)
state: West Yorkshire
city: Bristol
country: United Kingdom
facility: N. Bristol NHS Trust + Univ. of Bristol (52)
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales (31)
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital (44)
Study officials:
affiliation: Zurich University Hospital, Zurich, Switzerland
name: Peter Messmer, MD
role: PRINCIPAL_INVESTIGATOR
References: