Back to resultsSafety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures Requiring Grafting
Primary Purpose
Tibia Plateau Fractures
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
I-0401 (a new bone graft substitute)
Sponsored by
About this trial
This is an interventional treatment trial for Tibia Plateau Fractures focused on measuring Bone graft substitute, Promotion of bone healing
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.
Sites / Locations
- Gold Coast Hospital (49)
- Princess Alexandra Hospital (45)
- Royal Adelaide Hospital (48)
- Hopital La Cavale Blanche (19)
- Hôpital de Dunkerque (30)
- Hôpital Central de Nancy (05)
- Hôpital Charles Nicolle (15)
- Charite, Campus Virchow Klinikum (03)
- Berufsgenossenschaftliche Unfallklinik Bochum/Duisburg (11)
- Uniklinik Göttingen (22)
- Med. Hochschule Hannover (06)
- Universitätsklinikum Schleswig-Holstein (40)
- St.-Josef-Krankenhaus (12)
- Chirurgische Klinik der LMU (50)
- Universitätsklinikum Münster (39)
- Fövarosi Önkormanyzat Karolyi Sandor Korhaz es Rendelointezet (21)
- Fövarosi Önkormanyzat Peterfy Sandor utcai Korhaz-Rendelöinezet es Baleseti Központ (20)
- Fovárosi Önkormányzat Szent János Kórháza és Észak (54)
- Petz Alandar County Teaching Hospital (55)
- Szegedi Egyetem AOK Kari Gyogyszertar (27)
- Istituti Ortopedici Rizzoli (13)
- Fondazione Istituto San Raffaele G. Giglio di Cefalù (16)
- A.O. Universitaria San Martino (33)
- Università degli Studi di Roma "Tor Vergata" (10)
- A.O. San Giovanni Oddolorata (14)
- Klinika i Oddzial Kliniczny - Ortopedii i Traumatologii (36)
- Oddzial Chirurgii Ortopedyczno-Urazowej - Wojewodzki Szpital Specjalistyczny (58)
- SPZOZ Wojewodzki - Specjalistyczny Szpital Chirurgii Urazowej (35)
- Katedra i Klinika Ortopedii - Traumatologii PAM (34)
- Wojskowy Instytut Medyczny - Centralny Szpital Kliniczny MON (60)
- Katedra I Klinika Ortopedii AM (29)
- Hospital Universitario de la Princesa (18)
- Hospital FREMAP Majadahonda (17)
- Hospital Universitario Virgen de la Victoria (51)
- Hospital FREMAP Sevilla (32)
- Hospital Universitario La Fe (07)
- Zurich University Hospital (01)
- Universitätsspital Basel (24)
- Kantonsspital Bruderholz (25)
- CHUV Lausanne (02)
- Kantonsspital Luzern (26)
- Leeds General Infirmary (04)
- N. Bristol NHS Trust + Univ. of Bristol (52)
- University Hospital of Wales (31)
- Norfolk and Norwich University Hospital (44)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
Experimental - high dose
Experimental - low dose
Autograft
Outcomes
Primary Outcome Measures
Radiographic Images
Secondary Outcome Measures
Clinical assessments of the fracture site
Blood parameters
Vital signs
Questionnaires of Life
Pharmacoeconomic evaluation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00409799
Brief Title
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
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuros Biosurgery AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibia Plateau Fractures
Keywords
Bone graft substitute, Promotion of bone healing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Experimental - high dose
Arm Title
2
Arm Type
Experimental
Arm Description
Experimental - low dose
Arm Title
3
Arm Type
Active Comparator
Arm Description
Autograft
Intervention Type
Drug
Intervention Name(s)
I-0401 (a new bone graft substitute)
Intervention Description
1 time application
Primary Outcome Measure Information:
Title
Radiographic Images
Time Frame
All Follow-Up Visits
Secondary Outcome Measure Information:
Title
Clinical assessments of the fracture site
Time Frame
All Follow-Up Visits
Title
Blood parameters
Time Frame
All Follow-Up Visits
Title
Vital signs
Time Frame
At several Follow-Up visits
Title
Questionnaires of Life
Time Frame
All Follow-Up Visits
Title
Pharmacoeconomic evaluation
Time Frame
All Follow-Up Visits
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Messmer, MD
Organizational Affiliation
Zurich University Hospital, Zurich, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gold Coast Hospital (49)
City
Gold Coast
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Princess Alexandra Hospital (45)
City
Woollongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Adelaide Hospital (48)
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Hopital La Cavale Blanche (19)
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Hôpital de Dunkerque (30)
City
Dunkerque
ZIP/Postal Code
59380
Country
France
Facility Name
Hôpital Central de Nancy (05)
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Hôpital Charles Nicolle (15)
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Charite, Campus Virchow Klinikum (03)
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Berufsgenossenschaftliche Unfallklinik Bochum/Duisburg (11)
City
Duisburg
ZIP/Postal Code
47249
Country
Germany
Facility Name
Uniklinik Göttingen (22)
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Med. Hochschule Hannover (06)
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein (40)
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
St.-Josef-Krankenhaus (12)
City
Linnich
ZIP/Postal Code
52441
Country
Germany
Facility Name
Chirurgische Klinik der LMU (50)
City
München
ZIP/Postal Code
81366
Country
Germany
Facility Name
Universitätsklinikum Münster (39)
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Fövarosi Önkormanyzat Karolyi Sandor Korhaz es Rendelointezet (21)
City
Budapest
ZIP/Postal Code
1041
Country
Hungary
Facility Name
Fövarosi Önkormanyzat Peterfy Sandor utcai Korhaz-Rendelöinezet es Baleseti Központ (20)
City
Budapest
ZIP/Postal Code
1081
Country
Hungary
Facility Name
Fovárosi Önkormányzat Szent János Kórháza és Észak (54)
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Petz Alandar County Teaching Hospital (55)
City
Györ
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Szegedi Egyetem AOK Kari Gyogyszertar (27)
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Istituti Ortopedici Rizzoli (13)
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Facility Name
Fondazione Istituto San Raffaele G. Giglio di Cefalù (16)
City
Cefalù
ZIP/Postal Code
90015
Country
Italy
Facility Name
A.O. Universitaria San Martino (33)
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Università degli Studi di Roma "Tor Vergata" (10)
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
A.O. San Giovanni Oddolorata (14)
City
Roma
ZIP/Postal Code
00184
Country
Italy
Facility Name
Klinika i Oddzial Kliniczny - Ortopedii i Traumatologii (36)
City
Krakow
ZIP/Postal Code
31-826
Country
Poland
Facility Name
Oddzial Chirurgii Ortopedyczno-Urazowej - Wojewodzki Szpital Specjalistyczny (58)
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
SPZOZ Wojewodzki - Specjalistyczny Szpital Chirurgii Urazowej (35)
City
Piekary Slaskie
ZIP/Postal Code
41940
Country
Poland
Facility Name
Katedra i Klinika Ortopedii - Traumatologii PAM (34)
City
Szczecin
ZIP/Postal Code
71252
Country
Poland
Facility Name
Wojskowy Instytut Medyczny - Centralny Szpital Kliniczny MON (60)
City
Warsaw
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Katedra I Klinika Ortopedii AM (29)
City
Warszawa
ZIP/Postal Code
02005
Country
Poland
Facility Name
Hospital Universitario de la Princesa (18)
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital FREMAP Majadahonda (17)
City
Madrid
ZIP/Postal Code
28220
Country
Spain
Facility Name
Hospital Universitario Virgen de la Victoria (51)
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital FREMAP Sevilla (32)
City
Sevilla
ZIP/Postal Code
41012
Country
Spain
Facility Name
Hospital Universitario La Fe (07)
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Zurich University Hospital (01)
City
Zurich
State/Province
Canton Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Universitätsspital Basel (24)
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Kantonsspital Bruderholz (25)
City
Bruderholz
ZIP/Postal Code
4101
Country
Switzerland
Facility Name
CHUV Lausanne (02)
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Kantonsspital Luzern (26)
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Leeds General Infirmary (04)
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
N. Bristol NHS Trust + Univ. of Bristol (52)
City
Bristol
ZIP/Postal Code
BS16 1LE
Country
United Kingdom
Facility Name
University Hospital of Wales (31)
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Norfolk and Norwich University Hospital (44)
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures Requiring Grafting
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