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

This study has been completed.
Sponsor:
Collaborator:
Synthes Asia Pacific
Information provided by (Responsible Party):
Synthes GmbH
ClinicalTrials.gov Identifier:
NCT01132508
First received: February 16, 2010
Last updated: May 26, 2015
Last verified: May 2015
  Purpose

Case series of tibial plateau fractures using Norian Drillable.


Condition Intervention
Tibial Fractures
Device: Norian Drillable Bone Void Filler

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures

Resource links provided by NLM:


Further study details as provided by Synthes GmbH:

Primary Outcome Measures:
  • Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment [ Time Frame: Day 0 (Day of surgery) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Ease of Use Score Measured With a Surgeon Questionnaire: Drill [ Time Frame: Day 0 (Date of surgery) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon.


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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.

  • Radiographic Parameters: Depression at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Radiographic Parameters: Depression at Surgery [ Time Frame: Surgery ] [ Designated as safety issue: No ]
    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.

  • Radiographic Parameters: Depression at 6 Weeks [ Time Frame: 6 week ] [ Designated as safety issue: No ]
    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.

  • Radiographic Parameters: Depression at 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Radiographic Parameters: Depression at 26 Weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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.

  • Radiographic Parameters:: Depression at 52 Weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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.

  • Radiographic Parameters: Depression at 78 Weeks [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
    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.

  • Radiographic Parameters: Condylar Widening at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Radiographic Parameters: Condylar Widening at Surgery [ Time Frame: Surgery ] [ Designated as safety issue: No ]
    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.

  • Radiographic Parameters: Condylar Widening at 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Radiographic Parameters: Condylar Widening at 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Radiographic Parameters: Condylar Widening at 26 Weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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.

  • Radiographic Parameters: Condylar Widening at 52 Weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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.

  • Radiographic Parameters: Condylar Widening at 78 Weeks [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
    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.

  • Radiographic Parameters: Angulation (Valgus/Varus) at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Radiographic Parameters: Angulation (Valgus/Varus) at Surgery [ Time Frame: Surgery ] [ Designated as safety issue: No ]
    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.

  • Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

  • Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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.

  • Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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.

  • Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
    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.

  • Knee Function and Stability: Extension at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  • Knee Function and Stability: Extension at 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  • Knee Function and Stability: Extension at 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  • Knee Function and Stability: Extension at 26 Week [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  • Knee Function and Stability: Extension at 52 Weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  • Knee Function and Stability: Extension at 78 Weeks [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
    The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  • Knee Function and Stability: Total Range of Motion at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  • Knee Function and Stability: Total Range of Motion at 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  • Knee Function and Stability: Total Range of Motion at 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  • Knee Function and Stability: Total Range of Motion at 26 Weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  • Knee Function and Stability: Total Range of Motion at 52 Weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  • Knee Function and Stability: Total Range of Motion at 78 Weeks [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
    Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  • Knee Function and Stability: Extension Stability at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.

  • Knee Function and Stability: Extension Stability at 6 Weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.

  • Knee Function and Stability: Extension Stability at 12 Weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.

  • Knee Function and Stability: Extension Stability at 26 Weeks [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.

  • Knee Function and Stability: Extension Stability at 52 Weeks [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.

  • Knee Function and Stability: Extension Stability at 78 Weeks [ Time Frame: 78 weeks ] [ Designated as safety issue: No ]
    Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.


Enrollment: 33
Study Start Date: September 2008
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132508

Locations
Australia, New South Wales
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
John Hunter Hospital
New Lambton, New South Wales, Australia, 2305
China
Queen Mary Hospital
Hong Kong, China
Netherlands
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435
St. Elisabeth Ziekenhuis
Tilburg, Netherlands, 5022
Norway
Sykehuset I Vestfold
Tønsberg, Norway, 3103
Sponsors and Collaborators
Synthes GmbH
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
  More Information

No publications provided

Responsible Party: Synthes GmbH
ClinicalTrials.gov Identifier: NCT01132508     History of Changes
Other Study ID Numbers: ND-AUS-01
Study First Received: February 16, 2010
Results First Received: November 11, 2014
Last Updated: May 26, 2015
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Synthes GmbH:
Tibial plateau fracture
Orthopaedic Trauma Association (OTA) B2 B3 C3
Bone Void

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Leg Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 01, 2015