Case series of tibial plateau fractures using Norian Drillable.
This study is a multi-center, non-randomized prospective case series of tibial plateau fractures using Norian Drillable to fill bone voids, to evaluate OR time, blood loss, complications, ease of use, fracture stabilization and patient function and pain over time.
Study Type
OBSERVATIONAL
Enrollment
33
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
Liverpool Hospital
Liverpool, New South Wales, Australia
John Hunter Hospital
New Lambton, New South Wales, Australia
Queen Mary Hospital
Hong Kong, China
St. Antonius Ziekenhuis
Nieuwegein, Netherlands
Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment
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)
Time frame: Day 0 (Day of surgery)
Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment
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)
Time frame: Day 0 (Day of surgery)
Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device
Time frame: 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
Ease of Use Score Measured With a Surgeon Questionnaire: Drill
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.
Time frame: Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: K-wire
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.
Time frame: Day 0 (Date of surgery)
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St. Elisabeth Ziekenhuis
Tilburg, Netherlands
Sykehuset I Vestfold
Tønsberg, Norway
Ease of Use Score Measured With a Surgeon Questionnaire: Tap
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.
Time frame: Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion
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.
Time frame: Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Time frame: Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Time frame: Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Time frame: Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Time frame: Day 0 (Date of surgery)
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Time frame: Day 0 (Date of surgery)
Surgeons Overall Satisfaction With Norian Drillable
The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon.
Time frame: Surgery
Pain and Function Assessed With the Lysholm Knee Scale
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.
Time frame: 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only)
Radiographic Parameters: Depression at Baseline
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.
Time frame: Baseline
Radiographic Parameters: Depression at Surgery
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.
Time frame: Surgery
Radiographic Parameters: Depression at 6 Weeks
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.
Time frame: 6 week
Radiographic Parameters: Depression at 12 Weeks
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.
Time frame: 12 weeks
Radiographic Parameters: Depression at 26 Weeks
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.
Time frame: 26 weeks
Radiographic Parameters:: Depression at 52 Weeks
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.
Time frame: 52 weeks
Radiographic Parameters: Depression at 78 Weeks
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.
Time frame: 78 weeks
Radiographic Parameters: Condylar Widening at Baseline
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.
Time frame: Baseline
Radiographic Parameters: Condylar Widening at Surgery
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.
Time frame: Surgery
Radiographic Parameters: Condylar Widening at 6 Weeks
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.
Time frame: 6 weeks
Radiographic Parameters: Condylar Widening at 12 Weeks
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.
Time frame: 12 weeks
Radiographic Parameters: Condylar Widening at 26 Weeks
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.
Time frame: 26 weeks
Radiographic Parameters: Condylar Widening at 52 Weeks
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.
Time frame: 52 weeks
Radiographic Parameters: Condylar Widening at 78 Weeks
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.
Time frame: 78 weeks
Radiographic Parameters: Angulation (Valgus/Varus) at Baseline
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.
Time frame: Baseline
Radiographic Parameters: Angulation (Valgus/Varus) at Surgery
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.
Time frame: Surgery
Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks
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.
Time frame: 6 weeks
Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks
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.
Time frame: 12 weeks
Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks
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.
Time frame: 26 weeks
Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks
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.
Time frame: 52 weeks
Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks
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.
Time frame: 78 weeks
Knee Function and Stability: Extension at Baseline
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: Baseline
Knee Function and Stability: Extension at 6 Weeks
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 6 weeks
Knee Function and Stability: Extension at 12 Weeks
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 12 weeks
Knee Function and Stability: Extension at 26 Week
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 26 weeks
Knee Function and Stability: Extension at 52 Weeks
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 52 weeks
Knee Function and Stability: Extension at 78 Weeks
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 78 weeks
Knee Function and Stability: Total Range of Motion at Baseline
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: Baseline
Knee Function and Stability: Total Range of Motion at 6 Weeks
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 6 weeks
Knee Function and Stability: Total Range of Motion at 12 Weeks
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 12 weeks
Knee Function and Stability: Total Range of Motion at 26 Weeks
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 26 weeks
Knee Function and Stability: Total Range of Motion at 52 Weeks
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 52 weeks
Knee Function and Stability: Total Range of Motion at 78 Weeks
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 78 weeks
Knee Function and Stability: Extension Stability at Baseline
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: Baseline
Knee Function and Stability: Extension Stability at 6 Weeks
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 6 weeks
Knee Function and Stability: Extension Stability at 12 Weeks
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 12 weeks
Knee Function and Stability: Extension Stability at 26 Weeks
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 26 weeks
Knee Function and Stability: Extension Stability at 52 Weeks
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 52 weeks
Knee Function and Stability: Extension Stability at 78 Weeks
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
Time frame: 78 weeks