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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
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 website
https://clinicaltrials.gov/study/NCT00409799
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00409799