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

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.

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.

Study Overview

• Status: Completed
• Conditions: Tibia Plateau Fractures
• Intervention / Treatment: Drug: I-0401 (a new bone graft substitute)

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Gold Coast, Queensland, Australia, 4215
      • Gold Coast Hospital (49)
    • Woollongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital (45)
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital (48)
• France
  • Brest, France, 29200
    • Hopital La Cavale Blanche (19)
  • Dunkerque, France, 59380
    • Hôpital de Dunkerque (30)
  • Nancy, France, 54000
    • Hôpital Central de Nancy (05)
  • Rouen, France, 76031
    • Hôpital Charles Nicolle (15)
• Germany
  • Berlin, Germany, 13353
    • Charite, Campus Virchow Klinikum (03)
  • Duisburg, Germany, 47249
    • Berufsgenossenschaftliche Unfallklinik Bochum/Duisburg (11)
  • Göttingen, Germany, 37075
    • Uniklinik Göttingen (22)
  • Hannover, Germany, 30625
    • Med. Hochschule Hannover (06)
  • Kiel, Germany, 24105
    • Universitätsklinikum Schleswig-Holstein (40)
  • Linnich, Germany, 52441
    • St.-Josef-Krankenhaus (12)
  • München, Germany, 81366
    • Chirurgische Klinik der LMU (50)
  • Münster, Germany, 48149
    • Universitätsklinikum Münster (39)
• Hungary
  • Budapest, Hungary, 1041
    • Fövarosi Önkormanyzat Karolyi Sandor Korhaz es Rendelointezet (21)
  • Budapest, Hungary, 1081
    • Fövarosi Önkormanyzat Peterfy Sandor utcai Korhaz-Rendelöinezet es Baleseti Központ (20)
  • Budapest, Hungary, 1125
    • Fovárosi Önkormányzat Szent János Kórháza és Észak (54)
  • Györ, Hungary, 9024
    • Petz Alandar County Teaching Hospital (55)
  • Szeged, Hungary, 6725
    • Szegedi Egyetem AOK Kari Gyogyszertar (27)
• Italy
  • Bologna, Italy, 40136
    • Istituti Ortopedici Rizzoli (13)
  • Cefalù, Italy, 90015
    • Fondazione Istituto San Raffaele G. Giglio di Cefalù (16)
  • Genova, Italy, 16132
    • A.O. Universitaria San Martino (33)
  • Roma, Italy, 00133
    • Università degli Studi di Roma "Tor Vergata" (10)
  • Roma, Italy, 00184
    • A.O. San Giovanni Oddolorata (14)
• Poland
  • Krakow, Poland, 31-826
    • Klinika i Oddzial Kliniczny - Ortopedii i Traumatologii (36)
  • Lodz, Poland, 93-513
    • Oddzial Chirurgii Ortopedyczno-Urazowej - Wojewodzki Szpital Specjalistyczny (58)
  • Piekary Slaskie, Poland, 41940
    • SPZOZ Wojewodzki - Specjalistyczny Szpital Chirurgii Urazowej (35)
  • Szczecin, Poland, 71252
    • Katedra i Klinika Ortopedii - Traumatologii PAM (34)
  • Warsaw, Poland, 00-909
    • Wojskowy Instytut Medyczny - Centralny Szpital Kliniczny MON (60)
  • Warszawa, Poland, 02005
    • Katedra I Klinika Ortopedii AM (29)
• Spain
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa (18)
  • Madrid, Spain, 28220
    • Hospital FREMAP Majadahonda (17)
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria (51)
  • Sevilla, Spain, 41012
    • Hospital FREMAP Sevilla (32)
  • Valencia, Spain, 46009
    • Hospital Universitario La Fe (07)
• Switzerland
  • Basel, Switzerland, 4031
    • Universitätsspital Basel (24)
  • Bruderholz, Switzerland, 4101
    • Kantonsspital Bruderholz (25)
  • Lausanne, Switzerland, 1011
    • CHUV Lausanne (02)
  • Luzern, Switzerland, 6000
    • Kantonsspital Luzern (26)
  • Canton Zurich
    • Zurich, Canton Zurich, Switzerland, 8091
      • Zurich University Hospital (01)
• United Kingdom
  • Bristol, United Kingdom, BS16 1LE
    • N. Bristol NHS Trust + Univ. of Bristol (52)
  • Cardiff, United Kingdom, CF14 4XW
    • University Hospital of Wales (31)
  • Norwich, United Kingdom, NR4 7UY
    • Norfolk and Norwich University Hospital (44)
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS1 3EX
      • Leeds General Infirmary (04)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; Experimental - high dose	Drug: I-0401 (a new bone graft substitute); 1 time application
EXPERIMENTAL: 2; Experimental - low dose	Drug: I-0401 (a new bone graft substitute); 1 time application
ACTIVE_COMPARATOR: 3; Autograft	Drug: I-0401 (a new bone graft substitute); 1 time application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Radiographic Images	All Follow-Up Visits

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Kuros Biosurgery AG
• Investigators: Principal Investigator: Peter Messmer, MD, Zurich University Hospital, Zurich, Switzerland

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: December 8, 2006
• First Submitted That Met QC Criteria: December 8, 2006
• First Posted (ESTIMATE): December 11, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): March 16, 2012
• Last Update Submitted That Met QC Criteria: March 15, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Bone graft substitute; Promotion of bone healing
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: CS I-040101/02