Tibial FracturesNCT01132508
Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures
An observational study of Tibial Fractures, run by Synthes GmbH at 6 sites in 4 countries.
Trial summary
Case series of tibial plateau fractures using Norian Drillable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tibial Fractures
- What is being tested?
- Norian Drillable Bone Void Filler
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Sep 2008to Sep 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Australia2 sites
Liverpool Hospital
Liverpool, New South Wales, 2170
John Hunter Hospital
New Lambton, New South Wales, 2305
Netherlands2 sites
St. Antonius Ziekenhuis
Nieuwegein, 3435
St. Elisabeth Ziekenhuis
Tilburg, 5022
About this study
Case series of tibial plateau fractures using Norian Drillable.
Read the 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.
- Conditions
- Tibial Fractures
- Being tested
- Norian Drillable Bone Void Filler
- Keywords
- Tibial plateau fracture, Orthopaedic Trauma Association (OTA) B2 B3 C3, Bone Void
- Medical subject headings
- Tibial Fractures, Tibial Plateau Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norian Drillable Bone Void FillerDevice
Also called Norian Drillable
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Not described Receives: Device: Norian Drillable Bone Void Filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Day 0 (Day of surgery)
Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Surgery
Secondary outcomes (40)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 78 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startSep 2008
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tibial FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synthes GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Synthes Asia Pacific
- Responsible party
- Sponsor
- Investigators
- Zsolt Balogh, MD, Principal investigator, John Hunter Hospital, New Lambton, NSW, AustraliaIan Harris, MD, Principal investigator, Liverpool Hospital, Liverpool, NSW, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132508
- Sponsor's protocol ID
- ND-AUS-01
- Status last verified
- May 2015
- First submitted
- 16 Feb 2010
- Last updated
- 11 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures
- ClinicalTrials.gov ID
- NCT01132508
- Acronym / sponsor ID
- ND-AUS-01
- Conditions
- Tibial Fractures
- Keywords
- Tibial plateau fracture, Orthopaedic Trauma Association (OTA) B2 B3 C3, Bone Void
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Synthes GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Synthes Asia Pacific
- Study start
- Sep 2008
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 28 May 2010 (estimated)
- Results
- Posted 11 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Case series of tibial plateau fractures using Norian Drillable.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | – | Device: Norian Drillable Bone Void Filler |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- Critically ill
- Mentally ill or mentally disordered
- Wards of the state
- Prisoners
- Refugees
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Norian Drillable Bone Void FillerAlso: Norian DrillableNorian 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 | Device | Treatment |
Primary outcome
Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment
Time frame: Day 0 (Day of surgery)
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)
Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment
Time frame: Day 0 (Day of surgery)
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)
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
Time frame: Day 0 (Date of surgery)
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.
Ease of Use Score Measured With a Surgeon Questionnaire: K-wire
Time frame: Day 0 (Date of surgery)
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.
Ease of Use Score Measured With a Surgeon Questionnaire: Tap
Time frame: Day 0 (Date of surgery)
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.
Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion
Time frame: Day 0 (Date of surgery)
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.
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing
Time frame: Day 0 (Date of surgery)
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling
Time frame: Day 0 (Date of surgery)
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties
Time frame: Day 0 (Date of surgery)
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure
Time frame: Day 0 (Date of surgery)
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use
Time frame: Day 0 (Date of surgery)
Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
Surgeons Overall Satisfaction With Norian Drillable
Time frame: Surgery
The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon.
40 secondary outcomes
Pain and Function Assessed With the Lysholm Knee Scale
Time frame: 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only)
Radiographic Parameters: Depression at Baseline
Time frame: Baseline
Radiographic Parameters: Depression at Surgery
Time frame: Surgery
Radiographic Parameters: Depression at 6 Weeks
Time frame: 6 week
Radiographic Parameters: Depression at 12 Weeks
Time frame: 12 weeks
Radiographic Parameters: Depression at 26 Weeks
Time frame: 26 weeks
Radiographic Parameters:: Depression at 52 Weeks
Time frame: 52 weeks
Radiographic Parameters: Depression at 78 Weeks
Time frame: 78 weeks
Radiographic Parameters: Condylar Widening at Baseline
Time frame: Baseline
Radiographic Parameters: Condylar Widening at Surgery
Time frame: Surgery
Radiographic Parameters: Condylar Widening at 6 Weeks
Time frame: 6 weeks
Radiographic Parameters: Condylar Widening at 12 Weeks
Time frame: 12 weeks
Radiographic Parameters: Condylar Widening at 26 Weeks
Time frame: 26 weeks
Radiographic Parameters: Condylar Widening at 52 Weeks
Time frame: 52 weeks
Radiographic Parameters: Condylar Widening at 78 Weeks
Time frame: 78 weeks
Radiographic Parameters: Angulation (Valgus/Varus) at Baseline
Time frame: Baseline
Radiographic Parameters: Angulation (Valgus/Varus) at Surgery
Time frame: Surgery
Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks
Time frame: 6 weeks
Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks
Time frame: 12 weeks
Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks
Time frame: 26 weeks
Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks
Time frame: 52 weeks
Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks
Time frame: 78 weeks
Knee Function and Stability: Extension at Baseline
Time frame: Baseline
Knee Function and Stability: Extension at 6 Weeks
Time frame: 6 weeks
Knee Function and Stability: Extension at 12 Weeks
Time frame: 12 weeks
Knee Function and Stability: Extension at 26 Week
Time frame: 26 weeks
Knee Function and Stability: Extension at 52 Weeks
Time frame: 52 weeks
Knee Function and Stability: Extension at 78 Weeks
Time frame: 78 weeks
Knee Function and Stability: Total Range of Motion at Baseline
Time frame: Baseline
Knee Function and Stability: Total Range of Motion at 6 Weeks
Time frame: 6 weeks
Knee Function and Stability: Total Range of Motion at 12 Weeks
Time frame: 12 weeks
Knee Function and Stability: Total Range of Motion at 26 Weeks
Time frame: 26 weeks
Knee Function and Stability: Total Range of Motion at 52 Weeks
Time frame: 52 weeks
Knee Function and Stability: Total Range of Motion at 78 Weeks
Time frame: 78 weeks
Knee Function and Stability: Extension Stability at Baseline
Time frame: Baseline
Knee Function and Stability: Extension Stability at 6 Weeks
Time frame: 6 weeks
Knee Function and Stability: Extension Stability at 12 Weeks
Time frame: 12 weeks
Knee Function and Stability: Extension Stability at 26 Weeks
Time frame: 26 weeks
Knee Function and Stability: Extension Stability at 52 Weeks
Time frame: 52 weeks
Knee Function and Stability: Extension Stability at 78 Weeks
Time frame: 78 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zsolt Balogh, MD principal investigator
John Hunter Hospital, New Lambton, NSW, Australia
Ian Harris, MD principal investigator
Liverpool Hospital, Liverpool, NSW, Australia
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tibial Fractures, run by Synthes GmbH at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, Netherlands, China, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment (time frame: Day 0 (Day of surgery)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2015.