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

Phase 2

Completed

• Conditions: Tibia Plateau Fractures
• Interventions: Drug: I-0401 (a new bone graft substitute)

• Registration Number: NCT00409799
• Lead Sponsor: Kuros Biosurgery AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-12-08
• Study First Submitted QC: 2006-12-08
• Study First Posted: 2006-12-11
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	I-0401 (a new bone graft substitute)	Autograft
1	I-0401 (a new bone graft substitute)	Experimental - high dose
2	I-0401 (a new bone graft substitute)	Experimental - low dose

Primary Outcome Measures

Name	Time	Method
Radiographic Images	All Follow-Up Visits

Secondary Outcome Measures

Name	Time	Method
Clinical assessments of the fracture site	All Follow-Up Visits
Blood parameters	All Follow-Up Visits
Vital signs	At several Follow-Up visits
Questionnaires of Life	All Follow-Up Visits
Pharmacoeconomic evaluation	All Follow-Up Visits

Trial Locations

Locations (45)

Charite, Campus Virchow Klinikum (03); 🇩🇪 Berlin, Germany

CHUV Lausanne (02); 🇨🇭 Lausanne, Switzerland

Istituti Ortopedici Rizzoli (13); 🇮🇹 Bologna, Italy

Fövarosi Önkormanyzat Karolyi Sandor Korhaz es Rendelointezet (21); 🇭🇺 Budapest, Hungary

Hopital La Cavale Blanche (19); 🇫🇷 Brest, France

A.O. San Giovanni Oddolorata (14); 🇮🇹 Roma, Italy

Klinika i Oddzial Kliniczny - Ortopedii i Traumatologii (36); 🇵🇱 Krakow, Poland

Katedra I Klinika Ortopedii AM (29); 🇵🇱 Warszawa, Poland

Petz Alandar County Teaching Hospital (55); 🇭🇺 Györ, Hungary

Hôpital de Dunkerque (30); 🇫🇷 Dunkerque, France

Hôpital Central de Nancy (05); 🇫🇷 Nancy, France

Hospital Universitario La Fe (07); 🇪🇸 Valencia, Spain

A.O. Universitaria San Martino (33); 🇮🇹 Genova, Italy

Hospital Universitario Virgen de la Victoria (51); 🇪🇸 Málaga, Spain

Norfolk and Norwich University Hospital (44); 🇬🇧 Norwich, United Kingdom

Oddzial Chirurgii Ortopedyczno-Urazowej - Wojewodzki Szpital Specjalistyczny (58); 🇵🇱 Lodz, Poland

St.-Josef-Krankenhaus (12); 🇩🇪 Linnich, Germany

Hospital FREMAP Majadahonda (17); 🇪🇸 Madrid, Spain

Uniklinik Göttingen (22); 🇩🇪 Göttingen, Germany

Princess Alexandra Hospital (45); 🇦🇺 Woollongabba, Queensland, Australia

Gold Coast Hospital (49); 🇦🇺 Gold Coast, Queensland, Australia

Fondazione Istituto San Raffaele G. Giglio di Cefalù (16); 🇮🇹 Cefalù, Italy

Szegedi Egyetem AOK Kari Gyogyszertar (27); 🇭🇺 Szeged, Hungary

Katedra i Klinika Ortopedii - Traumatologii PAM (34); 🇵🇱 Szczecin, Poland

Università degli Studi di Roma "Tor Vergata" (10); 🇮🇹 Roma, Italy

Med. Hochschule Hannover (06); 🇩🇪 Hannover, Germany

Wojskowy Instytut Medyczny - Centralny Szpital Kliniczny MON (60); 🇵🇱 Warsaw, Poland

Hospital Universitario de la Princesa (18); 🇪🇸 Madrid, Spain

Hôpital Charles Nicolle (15); 🇫🇷 Rouen, France

Universitätsklinikum Münster (39); 🇩🇪 Münster, Germany

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

Fovárosi Önkormányzat Szent János Kórháza és Észak (54); 🇭🇺 Budapest, Hungary

Kantonsspital Bruderholz (25); 🇨🇭 Bruderholz, Switzerland

Leeds General Infirmary (04); 🇬🇧 Leeds, West Yorkshire, United Kingdom

Royal Adelaide Hospital (48); 🇦🇺 Adelaide, South Australia, Australia

N. Bristol NHS Trust + Univ. of Bristol (52); 🇬🇧 Bristol, United Kingdom

University Hospital of Wales (31); 🇬🇧 Cardiff, United Kingdom

Chirurgische Klinik der LMU (50); 🇩🇪 München, Germany

Hospital FREMAP Sevilla (32); 🇪🇸 Sevilla, Spain

Universitätsklinikum Schleswig-Holstein (40); 🇩🇪 Kiel, Germany

Berufsgenossenschaftliche Unfallklinik Bochum/Duisburg (11); 🇩🇪 Duisburg, Germany

SPZOZ Wojewodzki - Specjalistyczny Szpital Chirurgii Urazowej (35); 🇵🇱 Piekary Slaskie, Poland

Zurich University Hospital (01); 🇨🇭 Zurich, Canton Zurich, Switzerland

Universitätsspital Basel (24); 🇨🇭 Basel, Switzerland

Kantonsspital Luzern (26); 🇨🇭 Luzern, Switzerland