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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00409799




Registration number
NCT00409799
Ethics application status
Date submitted
8/12/2006
Date registered
11/12/2006
Date last updated
16/03/2012

Titles & IDs
Public title
Safety and Efficacy of I 0401 in the Treatment of Tibial Plateau Fractures Requiring Grafting
Scientific 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.
Secondary ID [1] 0 0
CS I-040101/02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tibia Plateau Fractures 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - I-0401 (a new bone graft substitute)

Experimental: 1 - Experimental - high dose

Experimental: 2 - Experimental - low dose

Active comparator: 3 - Autograft


Treatment: Drugs: I-0401 (a new bone graft substitute)
1 time application
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiographic Images
Timepoint [1] 0 0
All Follow-Up Visits
Secondary outcome [1] 0 0
Clinical assessments of the fracture site
Timepoint [1] 0 0
All Follow-Up Visits
Secondary outcome [2] 0 0
Blood parameters
Timepoint [2] 0 0
All Follow-Up Visits
Secondary outcome [3] 0 0
Vital signs
Timepoint [3] 0 0
At several Follow-Up visits
Secondary outcome [4] 0 0
Questionnaires of Life
Timepoint [4] 0 0
All Follow-Up Visits
Secondary outcome [5] 0 0
Pharmacoeconomic evaluation
Timepoint [5] 0 0
All Follow-Up Visits

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2011
Sample size
Target
Accrual to date
Final
208
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Gold Coast Hospital (49) - Gold Coast
Recruitment hospital [2] 0 0
Princess Alexandra Hospital (45) - Woollongabba
Recruitment hospital [3] 0 0
Royal Adelaide Hospital (48) - Adelaide
Recruitment postcode(s) [1] 0 0
4215 - Gold Coast
Recruitment postcode(s) [2] 0 0
4102 - Woollongabba
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Brest
Country [2] 0 0
France
State/province [2] 0 0
Dunkerque
Country [3] 0 0
France
State/province [3] 0 0
Nancy
Country [4] 0 0
France
State/province [4] 0 0
Rouen
Country [5] 0 0
Germany
State/province [5] 0 0
Berlin
Country [6] 0 0
Germany
State/province [6] 0 0
Duisburg
Country [7] 0 0
Germany
State/province [7] 0 0
Göttingen
Country [8] 0 0
Germany
State/province [8] 0 0
Hannover
Country [9] 0 0
Germany
State/province [9] 0 0
Kiel
Country [10] 0 0
Germany
State/province [10] 0 0
Linnich
Country [11] 0 0
Germany
State/province [11] 0 0
München
Country [12] 0 0
Germany
State/province [12] 0 0
Münster
Country [13] 0 0
Hungary
State/province [13] 0 0
Budapest
Country [14] 0 0
Hungary
State/province [14] 0 0
Györ
Country [15] 0 0
Hungary
State/province [15] 0 0
Szeged
Country [16] 0 0
Italy
State/province [16] 0 0
Bologna
Country [17] 0 0
Italy
State/province [17] 0 0
Cefalù
Country [18] 0 0
Italy
State/province [18] 0 0
Genova
Country [19] 0 0
Italy
State/province [19] 0 0
Roma
Country [20] 0 0
Poland
State/province [20] 0 0
Krakow
Country [21] 0 0
Poland
State/province [21] 0 0
Lodz
Country [22] 0 0
Poland
State/province [22] 0 0
Piekary Slaskie
Country [23] 0 0
Poland
State/province [23] 0 0
Szczecin
Country [24] 0 0
Poland
State/province [24] 0 0
Warsaw
Country [25] 0 0
Poland
State/province [25] 0 0
Warszawa
Country [26] 0 0
Spain
State/province [26] 0 0
Madrid
Country [27] 0 0
Spain
State/province [27] 0 0
Málaga
Country [28] 0 0
Spain
State/province [28] 0 0
Sevilla
Country [29] 0 0
Spain
State/province [29] 0 0
Valencia
Country [30] 0 0
Switzerland
State/province [30] 0 0
Canton Zurich
Country [31] 0 0
Switzerland
State/province [31] 0 0
Basel
Country [32] 0 0
Switzerland
State/province [32] 0 0
Bruderholz
Country [33] 0 0
Switzerland
State/province [33] 0 0
Lausanne
Country [34] 0 0
Switzerland
State/province [34] 0 0
Luzern
Country [35] 0 0
United Kingdom
State/province [35] 0 0
West Yorkshire
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Bristol
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Cardiff
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Norwich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Kuros Biosurgery AG
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Messmer, MD
Address 0 0
Zurich University Hospital, Zurich, Switzerland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00409799