Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures

Study Overview
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Brief Summary
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Case series of tibial plateau fractures using Norian Drillable.

Detailed Description
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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.

Official Title
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Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures

Conditions
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Tibial Fractures

Intervention / Treatment
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* Device: Norian Drillable Bone Void Filler


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment<br> | Device: Norian Drillable Bone Void Filler<br>* 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<br>* Other names: Norian Drillable;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | Day 0 (Day of surgery) | 
| Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device |  | 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. | 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. | Day 0 (Date of surgery) | 
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 78 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tibial plateau fracture, Orthopaedic Trauma Association (OTA) B2 B3 C3, Bone Void