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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures
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Secondary ID [1]
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ND-AUS-01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Tibial Fractures
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Condition category
Condition code
Injuries and Accidents
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0
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Fractures
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Musculoskeletal
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment
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Assessment method [1]
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Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the duration of time the patient was in the operating room (OR)
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Timepoint [1]
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Day 0 (Day of surgery)
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Primary outcome [2]
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Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment
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Assessment method [2]
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Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the estimated amount of blood loss (the amount of fluid used in irrigation should have been subtracted from the amount of fluid present in the suction canister at the completion of surgery. Any gauze used in the procedure should have been estimated for the ml of blood loss)
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Timepoint [2]
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Day 0 (Day of surgery)
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Primary outcome [3]
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Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device
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Assessment method [3]
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0
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Timepoint [3]
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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
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Primary outcome [4]
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Ease of Use Score Measured With a Surgeon Questionnaire: Drill
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Assessment method [4]
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Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.
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Timepoint [4]
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Day 0 (Date of surgery)
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Primary outcome [5]
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Ease of Use Score Measured With a Surgeon Questionnaire: K-wire
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Assessment method [5]
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Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.
Kirschner wires or K-wires are sterilized, sharpened, smooth stainless steel pins widely used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction in fractures.
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Timepoint [5]
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Day 0 (Date of surgery)
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Primary outcome [6]
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Ease of Use Score Measured With a Surgeon Questionnaire: Tap
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Assessment method [6]
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Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.
A tap is an instrument used to create threads in a hole drilled in bone.
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Timepoint [6]
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Day 0 (Date of surgery)
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Primary outcome [7]
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Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion
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Assessment method [7]
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Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.
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Timepoint [7]
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Day 0 (Date of surgery)
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Primary outcome [8]
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Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing
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Assessment method [8]
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Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
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Timepoint [8]
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Day 0 (Date of surgery)
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Primary outcome [9]
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Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling
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Assessment method [9]
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Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
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Timepoint [9]
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0
Day 0 (Date of surgery)
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Primary outcome [10]
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Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties
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Assessment method [10]
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Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
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Timepoint [10]
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0
Day 0 (Date of surgery)
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Primary outcome [11]
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Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure
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Assessment method [11]
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Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
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Timepoint [11]
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0
Day 0 (Date of surgery)
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Primary outcome [12]
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Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use
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Assessment method [12]
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Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
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Timepoint [12]
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Day 0 (Date of surgery)
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Primary outcome [13]
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Surgeons Overall Satisfaction With Norian Drillable
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Assessment method [13]
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The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon.
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Timepoint [13]
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Surgery
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Secondary outcome [1]
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Pain and Function Assessed With the Lysholm Knee Scale
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Assessment method [1]
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The Lysholm Knee Score assessed pain and function of the knee (by evaluating whether support for weight bearing was needed, the patients ability to climb stairs and to squat, whether the patients knee was instable and the patient experienced pain and swelling) and was completed by the patient before surgery and at Week 6, Week 12, Week 26, Week 52, Week 78 and Week 104 (for Australian sites only). The score ranged from 0 to 100 points with higher values indicating a better healing status of the knee.
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Timepoint [1]
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6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only)
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Secondary outcome [2]
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Radiographic Parameters: Depression at Baseline
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Assessment method [2]
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The anatomical grading parameter "depression" was assessed the following way: Anterior-Posterior (AP) and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
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Timepoint [2]
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Baseline
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Secondary outcome [3]
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Radiographic Parameters: Depression at Surgery
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Assessment method [3]
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The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
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Timepoint [3]
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Surgery
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Secondary outcome [4]
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Radiographic Parameters: Depression at 6 Weeks
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Assessment method [4]
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The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
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Timepoint [4]
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0
6 week
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Secondary outcome [5]
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Radiographic Parameters: Depression at 12 Weeks
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Assessment method [5]
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The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
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Timepoint [5]
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12 weeks
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Secondary outcome [6]
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Radiographic Parameters: Depression at 26 Weeks
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Assessment method [6]
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The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
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Timepoint [6]
0
0
26 weeks
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Secondary outcome [7]
0
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Radiographic Parameters:: Depression at 52 Weeks
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Assessment method [7]
0
0
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
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Timepoint [7]
0
0
52 weeks
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Secondary outcome [8]
0
0
Radiographic Parameters: Depression at 78 Weeks
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Assessment method [8]
0
0
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
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Timepoint [8]
0
0
78 weeks
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Secondary outcome [9]
0
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Radiographic Parameters: Condylar Widening at Baseline
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Assessment method [9]
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0
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
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Timepoint [9]
0
0
Baseline
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Secondary outcome [10]
0
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Radiographic Parameters: Condylar Widening at Surgery
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Assessment method [10]
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0
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
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Timepoint [10]
0
0
Surgery
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Secondary outcome [11]
0
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Radiographic Parameters: Condylar Widening at 6 Weeks
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Assessment method [11]
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0
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
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Timepoint [11]
0
0
6 weeks
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Secondary outcome [12]
0
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Radiographic Parameters: Condylar Widening at 12 Weeks
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Assessment method [12]
0
0
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
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Timepoint [12]
0
0
12 weeks
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Secondary outcome [13]
0
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Radiographic Parameters: Condylar Widening at 26 Weeks
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Assessment method [13]
0
0
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
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Timepoint [13]
0
0
26 weeks
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Secondary outcome [14]
0
0
Radiographic Parameters: Condylar Widening at 52 Weeks
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Assessment method [14]
0
0
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
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Timepoint [14]
0
0
52 weeks
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Secondary outcome [15]
0
0
Radiographic Parameters: Condylar Widening at 78 Weeks
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Assessment method [15]
0
0
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
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Timepoint [15]
0
0
78 weeks
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Secondary outcome [16]
0
0
Radiographic Parameters: Angulation (Valgus/Varus) at Baseline
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Assessment method [16]
0
0
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
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Timepoint [16]
0
0
Baseline
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Secondary outcome [17]
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0
Radiographic Parameters: Angulation (Valgus/Varus) at Surgery
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Assessment method [17]
0
0
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
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Timepoint [17]
0
0
Surgery
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Secondary outcome [18]
0
0
Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks
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Assessment method [18]
0
0
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
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Timepoint [18]
0
0
6 weeks
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Secondary outcome [19]
0
0
Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks
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Assessment method [19]
0
0
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
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Timepoint [19]
0
0
12 weeks
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Secondary outcome [20]
0
0
Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks
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Assessment method [20]
0
0
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Query!
Timepoint [20]
0
0
26 weeks
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Secondary outcome [21]
0
0
Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks
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Assessment method [21]
0
0
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Query!
Timepoint [21]
0
0
52 weeks
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Secondary outcome [22]
0
0
Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks
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Assessment method [22]
0
0
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Query!
Timepoint [22]
0
0
78 weeks
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Secondary outcome [23]
0
0
Knee Function and Stability: Extension at Baseline
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Assessment method [23]
0
0
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
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Timepoint [23]
0
0
Baseline
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Secondary outcome [24]
0
0
Knee Function and Stability: Extension at 6 Weeks
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Assessment method [24]
0
0
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
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Timepoint [24]
0
0
6 weeks
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Secondary outcome [25]
0
0
Knee Function and Stability: Extension at 12 Weeks
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Assessment method [25]
0
0
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Query!
Timepoint [25]
0
0
12 weeks
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Secondary outcome [26]
0
0
Knee Function and Stability: Extension at 26 Week
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Assessment method [26]
0
0
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Query!
Timepoint [26]
0
0
26 weeks
Query!
Secondary outcome [27]
0
0
Knee Function and Stability: Extension at 52 Weeks
Query!
Assessment method [27]
0
0
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Query!
Timepoint [27]
0
0
52 weeks
Query!
Secondary outcome [28]
0
0
Knee Function and Stability: Extension at 78 Weeks
Query!
Assessment method [28]
0
0
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Query!
Timepoint [28]
0
0
78 weeks
Query!
Secondary outcome [29]
0
0
Knee Function and Stability: Total Range of Motion at Baseline
Query!
Assessment method [29]
0
0
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Query!
Timepoint [29]
0
0
Baseline
Query!
Secondary outcome [30]
0
0
Knee Function and Stability: Total Range of Motion at 6 Weeks
Query!
Assessment method [30]
0
0
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Query!
Timepoint [30]
0
0
6 weeks
Query!
Secondary outcome [31]
0
0
Knee Function and Stability: Total Range of Motion at 12 Weeks
Query!
Assessment method [31]
0
0
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Query!
Timepoint [31]
0
0
12 weeks
Query!
Secondary outcome [32]
0
0
Knee Function and Stability: Total Range of Motion at 26 Weeks
Query!
Assessment method [32]
0
0
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Query!
Timepoint [32]
0
0
26 weeks
Query!
Secondary outcome [33]
0
0
Knee Function and Stability: Total Range of Motion at 52 Weeks
Query!
Assessment method [33]
0
0
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Query!
Timepoint [33]
0
0
52 weeks
Query!
Secondary outcome [34]
0
0
Knee Function and Stability: Total Range of Motion at 78 Weeks
Query!
Assessment method [34]
0
0
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Query!
Timepoint [34]
0
0
78 weeks
Query!
Secondary outcome [35]
0
0
Knee Function and Stability: Extension Stability at Baseline
Query!
Assessment method [35]
0
0
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
Query!
Timepoint [35]
0
0
Baseline
Query!
Secondary outcome [36]
0
0
Knee Function and Stability: Extension Stability at 6 Weeks
Query!
Assessment method [36]
0
0
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
Query!
Timepoint [36]
0
0
6 weeks
Query!
Secondary outcome [37]
0
0
Knee Function and Stability: Extension Stability at 12 Weeks
Query!
Assessment method [37]
0
0
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
Query!
Timepoint [37]
0
0
12 weeks
Query!
Secondary outcome [38]
0
0
Knee Function and Stability: Extension Stability at 26 Weeks
Query!
Assessment method [38]
0
0
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
Query!
Timepoint [38]
0
0
26 weeks
Query!
Secondary outcome [39]
0
0
Knee Function and Stability: Extension Stability at 52 Weeks
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Assessment method [39]
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0
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
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Timepoint [39]
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0
52 weeks
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Secondary outcome [40]
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0
Knee Function and Stability: Extension Stability at 78 Weeks
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Assessment method [40]
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0
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
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Timepoint [40]
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0
78 weeks
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2013
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Sample size
Target
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Accrual to date
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Final
33
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
0
0
Liverpool Hospital - Liverpool
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Recruitment hospital [2]
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0
John Hunter Hospital - New Lambton
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Recruitment postcode(s) [1]
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0
2170 - Liverpool
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Recruitment postcode(s) [2]
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0
2305 - New Lambton
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Recruitment outside Australia
Country [1]
0
0
China
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State/province [1]
0
0
Hong Kong
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Country [2]
0
0
Netherlands
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State/province [2]
0
0
Nieuwegein
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Country [3]
0
0
Netherlands
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State/province [3]
0
0
Tilburg
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Country [4]
0
0
Norway
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State/province [4]
0
0
Tønsberg
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Synthes GmbH
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/Industry
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Name [1]
0
0
Synthes Asia Pacific
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Address [1]
0
0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
Case series of tibial plateau fractures using Norian Drillable.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01132508
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Zsolt Balogh, MD
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Address
0
0
John Hunter Hospital, New Lambton, NSW, Australia
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01132508
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