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

Completed

Conditions: Tibial Fractures

Interventions: Device: Norian Drillable Bone Void Filler

Registration Number: NCT01132508

Lead Sponsor: Synthes GmbH

Brief Summary: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 33

Inclusion Criteria

Subjects with closed tibial plateau fractures classified as OTA B2, B3 or C3 resulting in a bone void.
At least 18 years of age.
Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.
Signed informed consent.

Exclusion Criteria

Critically ill
Mentally ill or mentally disordered
Wards of the state
Prisoners
Refugees
In an employer - employee, teacher - student relationship or any other dependant with the researchers or their associates
Active or suspected infection - systemic or local
Gustillo classification of 2 or 3
Bilateral tibial plateau fractures when both fracture patterns extend into the joint
Have an existing calcium metabolism disorder (e.g. hypercalcemia)
Chronic renal disease/renal failure
Insulin dependent diabetes
Taking medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids).
Rheumatoid arthritis or other autoimmune disease.
Systemic disease including AIDS, HIV, hepatitis.
Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.
Subjects involved in other studies within the last month, prior to screening.
Pregnant or interested in becoming pregnant in the next 18 months. Females of child-bearing potential must use an acceptable method of contraception during trial participation.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment	Norian Drillable Bone Void Filler	-

Primary Outcome Measures

Name	Time	Method
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling	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: Drill	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	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	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.
Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment	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)
Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion	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.
Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment	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	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: Product Characteristics Mixing	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	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	Surgery	The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon.
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties	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	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.

Secondary Outcome Measures

Name	Time	Method
Radiographic Parameters:: Depression at 52 Weeks	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.
Knee Function and Stability: Extension Stability at 26 Weeks	26 weeks	Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
Radiographic Parameters: Depression at Baseline	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.
Radiographic Parameters: Condylar Widening at 6 Weeks	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.
Pain and Function Assessed With the Lysholm Knee Scale	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.
Knee Function and Stability: Extension Stability at Baseline	Baseline	Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
Radiographic Parameters: Condylar Widening at Baseline	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.
Radiographic Parameters: Condylar Widening at 78 Weeks	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.
Radiographic Parameters: Angulation (Valgus/Varus) at Surgery	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.
Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks	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.
Knee Function and Stability: Extension at 78 Weeks	78 weeks	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	Baseline	Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Radiographic Parameters: Depression at 6 Weeks	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.
Knee Function and Stability: Extension at 6 Weeks	6 weeks	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	12 weeks	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	52 weeks	The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Radiographic Parameters: Depression at Surgery	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.
Radiographic Parameters: Depression at 12 Weeks	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.
Radiographic Parameters: Depression at 26 Weeks	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.
Radiographic Parameters: Depression at 78 Weeks	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.
Radiographic Parameters: Condylar Widening at 26 Weeks	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.
Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks	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.
Knee Function and Stability: Total Range of Motion at 78 Weeks	78 weeks	Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Radiographic Parameters: Condylar Widening at Surgery	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.
Radiographic Parameters: Condylar Widening at 12 Weeks	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.
Radiographic Parameters: Condylar Widening at 52 Weeks	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.
Radiographic Parameters: Angulation (Valgus/Varus) at Baseline	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.
Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks	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.
Knee Function and Stability: Extension at 26 Week	26 weeks	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 Stability at 52 Weeks	52 weeks	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	78 weeks	Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks	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.
Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks	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.
Knee Function and Stability: Extension at Baseline	Baseline	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 6 Weeks	6 weeks	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	12 weeks	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	26 weeks	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	52 weeks	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 6 Weeks	6 weeks	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	12 weeks	Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.

Trial Locations

Locations (6): Liverpool Hospital
🇦🇺
Liverpool, New South Wales, Australia
St. Elisabeth Ziekenhuis
🇳🇱
Tilburg, Netherlands
Sykehuset I Vestfold
🇳🇴
Tønsberg, Norway
Queen Mary Hospital
🇨🇳
Hong Kong, China
John Hunter Hospital
🇦🇺
New Lambton, New South Wales, Australia
St. Antonius Ziekenhuis
🇳🇱
Nieuwegein, Netherlands