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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01132508




Registration number
NCT01132508
Ethics application status
Date submitted
16/02/2010
Date registered
28/05/2010
Date last updated
11/06/2015

Titles & IDs
Public title
Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures
Scientific title
Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures
Secondary ID [1] 0 0
ND-AUS-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tibial 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
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Norian Drillable Bone Void Filler

Treatment -


Treatment: Devices: Norian Drillable Bone Void Filler
Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment
Timepoint [1] 0 0
Day 0 (Day of surgery)
Primary outcome [2] 0 0
Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment
Timepoint [2] 0 0
Day 0 (Day of surgery)
Primary outcome [3] 0 0
Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device
Timepoint [3] 0 0
At enrolment (between day -7 and day 0), day 0 (day of surgery), 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 (for Australian sites only) postoperative
Primary outcome [4] 0 0
Ease of Use Score Measured With a Surgeon Questionnaire: Drill
Timepoint [4] 0 0
Day 0 (Date of surgery)
Primary outcome [5] 0 0
Ease of Use Score Measured With a Surgeon Questionnaire: K-wire
Timepoint [5] 0 0
Day 0 (Date of surgery)
Primary outcome [6] 0 0
Ease of Use Score Measured With a Surgeon Questionnaire: Tap
Timepoint [6] 0 0
Day 0 (Date of surgery)
Primary outcome [7] 0 0
Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion
Timepoint [7] 0 0
Day 0 (Date of surgery)
Primary outcome [8] 0 0
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing
Timepoint [8] 0 0
Day 0 (Date of surgery)
Primary outcome [9] 0 0
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling
Timepoint [9] 0 0
Day 0 (Date of surgery)
Primary outcome [10] 0 0
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties
Timepoint [10] 0 0
Day 0 (Date of surgery)
Primary outcome [11] 0 0
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure
Timepoint [11] 0 0
Day 0 (Date of surgery)
Primary outcome [12] 0 0
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use
Timepoint [12] 0 0
Day 0 (Date of surgery)
Primary outcome [13] 0 0
Surgeons Overall Satisfaction With Norian Drillable
Timepoint [13] 0 0
Surgery
Secondary outcome [1] 0 0
Pain and Function Assessed With the Lysholm Knee Scale
Timepoint [1] 0 0
6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only)
Secondary outcome [2] 0 0
Radiographic Parameters: Depression at Baseline
Timepoint [2] 0 0
Baseline
Secondary outcome [3] 0 0
Radiographic Parameters: Depression at Surgery
Timepoint [3] 0 0
Surgery
Secondary outcome [4] 0 0
Radiographic Parameters: Depression at 6 Weeks
Timepoint [4] 0 0
6 week
Secondary outcome [5] 0 0
Radiographic Parameters: Depression at 12 Weeks
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
Radiographic Parameters: Depression at 26 Weeks
Timepoint [6] 0 0
26 weeks
Secondary outcome [7] 0 0
Radiographic Parameters:: Depression at 52 Weeks
Timepoint [7] 0 0
52 weeks
Secondary outcome [8] 0 0
Radiographic Parameters: Depression at 78 Weeks
Timepoint [8] 0 0
78 weeks
Secondary outcome [9] 0 0
Radiographic Parameters: Condylar Widening at Baseline
Timepoint [9] 0 0
Baseline
Secondary outcome [10] 0 0
Radiographic Parameters: Condylar Widening at Surgery
Timepoint [10] 0 0
Surgery
Secondary outcome [11] 0 0
Radiographic Parameters: Condylar Widening at 6 Weeks
Timepoint [11] 0 0
6 weeks
Secondary outcome [12] 0 0
Radiographic Parameters: Condylar Widening at 12 Weeks
Timepoint [12] 0 0
12 weeks
Secondary outcome [13] 0 0
Radiographic Parameters: Condylar Widening at 26 Weeks
Timepoint [13] 0 0
26 weeks
Secondary outcome [14] 0 0
Radiographic Parameters: Condylar Widening at 52 Weeks
Timepoint [14] 0 0
52 weeks
Secondary outcome [15] 0 0
Radiographic Parameters: Condylar Widening at 78 Weeks
Timepoint [15] 0 0
78 weeks
Secondary outcome [16] 0 0
Radiographic Parameters: Angulation (Valgus/Varus) at Baseline
Timepoint [16] 0 0
Baseline
Secondary outcome [17] 0 0
Radiographic Parameters: Angulation (Valgus/Varus) at Surgery
Timepoint [17] 0 0
Surgery
Secondary outcome [18] 0 0
Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks
Timepoint [18] 0 0
6 weeks
Secondary outcome [19] 0 0
Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks
Timepoint [19] 0 0
12 weeks
Secondary outcome [20] 0 0
Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks
Timepoint [20] 0 0
26 weeks
Secondary outcome [21] 0 0
Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks
Timepoint [21] 0 0
52 weeks
Secondary outcome [22] 0 0
Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks
Timepoint [22] 0 0
78 weeks
Secondary outcome [23] 0 0
Knee Function and Stability: Extension at Baseline
Timepoint [23] 0 0
Baseline
Secondary outcome [24] 0 0
Knee Function and Stability: Extension at 6 Weeks
Timepoint [24] 0 0
6 weeks
Secondary outcome [25] 0 0
Knee Function and Stability: Extension at 12 Weeks
Timepoint [25] 0 0
12 weeks
Secondary outcome [26] 0 0
Knee Function and Stability: Extension at 26 Week
Timepoint [26] 0 0
26 weeks
Secondary outcome [27] 0 0
Knee Function and Stability: Extension at 52 Weeks
Timepoint [27] 0 0
52 weeks
Secondary outcome [28] 0 0
Knee Function and Stability: Extension at 78 Weeks
Timepoint [28] 0 0
78 weeks
Secondary outcome [29] 0 0
Knee Function and Stability: Total Range of Motion at Baseline
Timepoint [29] 0 0
Baseline
Secondary outcome [30] 0 0
Knee Function and Stability: Total Range of Motion at 6 Weeks
Timepoint [30] 0 0
6 weeks
Secondary outcome [31] 0 0
Knee Function and Stability: Total Range of Motion at 12 Weeks
Timepoint [31] 0 0
12 weeks
Secondary outcome [32] 0 0
Knee Function and Stability: Total Range of Motion at 26 Weeks
Timepoint [32] 0 0
26 weeks
Secondary outcome [33] 0 0
Knee Function and Stability: Total Range of Motion at 52 Weeks
Timepoint [33] 0 0
52 weeks
Secondary outcome [34] 0 0
Knee Function and Stability: Total Range of Motion at 78 Weeks
Timepoint [34] 0 0
78 weeks
Secondary outcome [35] 0 0
Knee Function and Stability: Extension Stability at Baseline
Timepoint [35] 0 0
Baseline
Secondary outcome [36] 0 0
Knee Function and Stability: Extension Stability at 6 Weeks
Timepoint [36] 0 0
6 weeks
Secondary outcome [37] 0 0
Knee Function and Stability: Extension Stability at 12 Weeks
Timepoint [37] 0 0
12 weeks
Secondary outcome [38] 0 0
Knee Function and Stability: Extension Stability at 26 Weeks
Timepoint [38] 0 0
26 weeks
Secondary outcome [39] 0 0
Knee Function and Stability: Extension Stability at 52 Weeks
Timepoint [39] 0 0
52 weeks
Secondary outcome [40] 0 0
Knee Function and Stability: Extension Stability at 78 Weeks
Timepoint [40] 0 0
78 weeks

Eligibility
Key inclusion criteria
* Subjects with closed tibial plateau fractures classified as OTA B2, B3 or C3 resulting in a bone void.
* At least 18 years of age.
* Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.
* Signed informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Critically ill
* Mentally ill or mentally disordered
* Wards of the state
* Prisoners
* Refugees
* In an employer - employee, teacher - student relationship or any other dependant with the researchers or their associates
* Active or suspected infection - systemic or local
* Gustillo classification of 2 or 3
* Bilateral tibial plateau fractures when both fracture patterns extend into the joint
* Have an existing calcium metabolism disorder (e.g. hypercalcemia)
* Chronic renal disease/renal failure
* Insulin dependent diabetes
* Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids).
* Rheumatoid arthritis or other autoimmune disease.
* Systemic disease including AIDS, HIV, hepatitis.
* Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.
* Subjects involved in other studies within the last month, prior to screening.
* Pregnant or interested in becoming pregnant in the next 18 months. Females of child-bearing potential must use an acceptable method of contraception during trial participation.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2013
Sample size
Target
Accrual to date
Final
33
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2305 - New Lambton
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Hong Kong
Country [2] 0 0
Netherlands
State/province [2] 0 0
Nieuwegein
Country [3] 0 0
Netherlands
State/province [3] 0 0
Tilburg
Country [4] 0 0
Norway
State/province [4] 0 0
Tønsberg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Synthes GmbH
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Synthes Asia Pacific
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Zsolt Balogh, MD
Address 0 0
John Hunter Hospital, New Lambton, NSW, Australia
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 are available at https://clinicaltrials.gov/study/NCT01132508