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

Case series of tibial plateau fractures using Norian Drillable.

Study Overview

• Status: Completed
• Conditions: Tibial Fractures
• Intervention / Treatment: Device: Norian Drillable Bone Void Filler

Detailed Description

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 (Actual): 33

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital
    • New Lambton, New South Wales, Australia, 2305
      • John Hunter Hospital
• China
  • Hong Kong, China
    • Queen Mary Hospital
• Netherlands
  • Nieuwegein, Netherlands, 3435
    • St. Antonius Ziekenhuis
  • Tilburg, Netherlands, 5022
    • St. Elisabeth Ziekenhuis
• Norway
  • Tønsberg, Norway, 3103
    • Sykehuset i Vestfold

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Treatment

Device: 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; Other Names: Norian Drillable

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Synthes GmbH
• Collaborators: Synthes Asia Pacific
• Investigators: Principal Investigator: Zsolt Balogh, MD, John Hunter Hospital, New Lambton, NSW, Australia; Principal Investigator: Ian Harris, MD, Liverpool Hospital, Liverpool, NSW, Australia

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: February 16, 2010
• First Submitted That Met QC Criteria: May 26, 2010
• First Posted (Estimate): May 28, 2010

Study Record Updates

• Last Update Posted (Estimate): June 11, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Tibial plateau fracture; Orthopaedic Trauma Association (OTA) B2 B3 C3; Bone Void
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Tibial Fractures
• Other Study ID Numbers: ND-AUS-01