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Completed

NCT Number: NCT01132508

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.

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Key information

Conditions

Tibial Fractures Fractures, Bone Knee Fractures Knee Injuries Leg Injuries Tibial Plateau Fractures Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Liverpool Hospital, Liverpool, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Norian Drillable Bone Void Filler

Device

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

Primary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

Secondary outcomes

  1. 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)

    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.

  2. Radiographic Parameters: Depression at Baseline

    Time frame: 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.

  3. Radiographic Parameters: Depression at Surgery

    Time frame: 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.

  4. Radiographic Parameters: Depression at 6 Weeks

    Time frame: 6 week

    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.

  5. Radiographic Parameters: Depression at 12 Weeks

    Time frame: 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.

  6. Radiographic Parameters: Depression at 26 Weeks

    Time frame: 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.

  7. Radiographic Parameters:: Depression at 52 Weeks

    Time frame: 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.

  8. Radiographic Parameters: Depression at 78 Weeks

    Time frame: 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.

  9. Radiographic Parameters: Condylar Widening at Baseline

    Time frame: 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.

  10. Radiographic Parameters: Condylar Widening at Surgery

    Time frame: 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.

  11. Radiographic Parameters: Condylar Widening at 6 Weeks

    Time frame: 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.

  12. Radiographic Parameters: Condylar Widening at 12 Weeks

    Time frame: 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.

  13. Radiographic Parameters: Condylar Widening at 26 Weeks

    Time frame: 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.

  14. Radiographic Parameters: Condylar Widening at 52 Weeks

    Time frame: 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.

  15. Radiographic Parameters: Condylar Widening at 78 Weeks

    Time frame: 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.

  16. Radiographic Parameters: Angulation (Valgus/Varus) at Baseline

    Time frame: 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.

  17. Radiographic Parameters: Angulation (Valgus/Varus) at Surgery

    Time frame: 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.

  18. Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks

    Time frame: 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.

  19. Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks

    Time frame: 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.

  20. Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks

    Time frame: 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.

  21. Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks

    Time frame: 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.

  22. Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks

    Time frame: 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.

  23. Knee Function and Stability: Extension at Baseline

    Time frame: Baseline

    The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  24. Knee Function and Stability: Extension at 6 Weeks

    Time frame: 6 weeks

    The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  25. Knee Function and Stability: Extension at 12 Weeks

    Time frame: 12 weeks

    The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  26. Knee Function and Stability: Extension at 26 Week

    Time frame: 26 weeks

    The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  27. Knee Function and Stability: Extension at 52 Weeks

    Time frame: 52 weeks

    The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  28. Knee Function and Stability: Extension at 78 Weeks

    Time frame: 78 weeks

    The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  29. Knee Function and Stability: Total Range of Motion at Baseline

    Time frame: Baseline

    Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  30. Knee Function and Stability: Total Range of Motion at 6 Weeks

    Time frame: 6 weeks

    Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  31. Knee Function and Stability: Total Range of Motion at 12 Weeks

    Time frame: 12 weeks

    Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  32. Knee Function and Stability: Total Range of Motion at 26 Weeks

    Time frame: 26 weeks

    Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  33. Knee Function and Stability: Total Range of Motion at 52 Weeks

    Time frame: 52 weeks

    Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  34. Knee Function and Stability: Total Range of Motion at 78 Weeks

    Time frame: 78 weeks

    Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.

  35. Knee Function and Stability: Extension Stability at Baseline

    Time frame: Baseline

    Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.

  36. Knee Function and Stability: Extension Stability at 6 Weeks

    Time frame: 6 weeks

    Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.

  37. Knee Function and Stability: Extension Stability at 12 Weeks

    Time frame: 12 weeks

    Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.

  38. Knee Function and Stability: Extension Stability at 26 Weeks

    Time frame: 26 weeks

    Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.

  39. Knee Function and Stability: Extension Stability at 52 Weeks

    Time frame: 52 weeks

    Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.

  40. Knee Function and Stability: Extension Stability at 78 Weeks

    Time frame: 78 weeks

    Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.

Sponsors and collaborators

Lead sponsor

Synthes GmbH

Industry

Collaborators

  • Synthes Asia Pacific

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
May 28, 2010
Registry last updated
Jun 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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