NCT00409799

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2006

Longer than P75 for phase_2

Geographic Reach
9 countries

45 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 8, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2006

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

Enrollment Period

4.8 years

First QC Date

December 8, 2006

Last Update Submit

March 15, 2012

Conditions

Tibia Plateau Fractures

Keywords

Bone graft substitutePromotion of bone healing

Outcome Measures

Primary Outcomes (1)

  • Radiographic Images

    All Follow-Up Visits

Secondary Outcomes (5)

  • 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

Study Arms (3)

1

EXPERIMENTAL

Experimental - high dose

Drug: I-0401 (a new bone graft substitute)

2

EXPERIMENTAL

Experimental - low dose

Drug: I-0401 (a new bone graft substitute)

3

ACTIVE COMPARATOR

Autograft

Drug: I-0401 (a new bone graft substitute)

Interventions

I-0401 (a new bone graft substitute)DRUG

1 time application

123

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (45)

Gold Coast Hospital (49)

Gold Coast, Queensland, 4215, Australia

Location

Princess Alexandra Hospital (45)

Woollongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital (48)

Adelaide, South Australia, 5000, Australia

Location

Hopital La Cavale Blanche (19)

Brest, 29200, France

Location

Hôpital de Dunkerque (30)

Dunkirk, 59380, France

Location

Hôpital Central de Nancy (05)

Nancy, 54000, France

Location

Hôpital Charles Nicolle (15)

Rouen, 76031, France

Location

Charite, Campus Virchow Klinikum (03)

Berlin, 13353, Germany

Location

Berufsgenossenschaftliche Unfallklinik Bochum/Duisburg (11)

Duisburg, 47249, Germany

Location

Uniklinik Göttingen (22)

Göttingen, 37075, Germany

Location

Med. Hochschule Hannover (06)

Hanover, 30625, Germany

Location

Universitätsklinikum Schleswig-Holstein (40)

Kiel, 24105, Germany

Location

St.-Josef-Krankenhaus (12)

Linnich, 52441, Germany

Location

Chirurgische Klinik der LMU (50)

München, 81366, Germany

Location

Universitätsklinikum Münster (39)

Münster, 48149, Germany

Location

Fövarosi Önkormanyzat Karolyi Sandor Korhaz es Rendelointezet (21)

Budapest, 1041, Hungary

Location

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

Budapest, 1081, Hungary

Location

Fovárosi Önkormányzat Szent János Kórháza és Észak (54)

Budapest, 1125, Hungary

Location

Petz Alandar County Teaching Hospital (55)

Győr, 9024, Hungary

Location

Szegedi Egyetem AOK Kari Gyogyszertar (27)

Szeged, 6725, Hungary

Location

Istituti Ortopedici Rizzoli (13)

Bologna, 40136, Italy

Location

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

Cefalù, 90015, Italy

Location

A.O. Universitaria San Martino (33)

Genova, 16132, Italy

Location

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

Roma, 00133, Italy

Location

A.O. San Giovanni Oddolorata (14)

Roma, 00184, Italy

Location

Klinika i Oddzial Kliniczny - Ortopedii i Traumatologii (36)

Krakow, 31-826, Poland

Location

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

Lodz, 93-513, Poland

Location

SPZOZ Wojewodzki - Specjalistyczny Szpital Chirurgii Urazowej (35)

Piekary Śląskie, 41940, Poland

Location

Katedra i Klinika Ortopedii - Traumatologii PAM (34)

Szczecin, 71252, Poland

Location

Wojskowy Instytut Medyczny - Centralny Szpital Kliniczny MON (60)

Warsaw, 00-909, Poland

Location

Katedra I Klinika Ortopedii AM (29)

Warsaw, 02005, Poland

Location

Hospital Universitario de la Princesa (18)

Madrid, 28006, Spain

Location

Hospital FREMAP Majadahonda (17)

Madrid, 28220, Spain

Location

Hospital Universitario Virgen de la Victoria (51)

Málaga, 29010, Spain

Location

Hospital FREMAP Sevilla (32)

Seville, 41012, Spain

Location

Hospital Universitario La Fe (07)

Valencia, 46009, Spain

Location

Zurich University Hospital (01)

Zurich, Canton Zurich, 8091, Switzerland

Location

Universitätsspital Basel (24)

Basel, 4031, Switzerland

Location

Kantonsspital Bruderholz (25)

Bruderholz, 4101, Switzerland

Location

CHUV Lausanne (02)

Lausanne, 1011, Switzerland

Location

Kantonsspital Luzern (26)

Lucerne, 6000, Switzerland

Location

Leeds General Infirmary (04)

Leeds, West Yorkshire, LS1 3EX, United Kingdom

Location

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

Bristol, BS16 1LE, United Kingdom

Location

University Hospital of Wales (31)

Cardiff, CF14 4XW, United Kingdom

Location

Norfolk and Norwich University Hospital (44)

Norwich, NR4 7UY, United Kingdom

Location

Related Publications (1)

  • Smith TO, Casey L, McNamara IR, Hing CB. Surgical fixation methods for tibial plateau fractures. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD009679. doi: 10.1002/14651858.CD009679.pub3.

    PMID: 39171616DERIVED

Study Officials

  • Peter Messmer, MD

    Zurich University Hospital, Zurich, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2006

First Posted

December 11, 2006

Study Start

November 1, 2006

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

March 16, 2012

Record last verified: 2012-03

Locations

FR(4)IT(5)GB(4)PL(6)ES(5)AU(3)CH(5)DE(8)HU(5)