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

Tibial Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01132508
• Other study ID #: ND-AUS-01
• Status: Completed
• Phase: N/A
• First received: February 16, 2010
• Last updated: May 26, 2015
• Start date: September 2008
• Est. completion date: September 2013

Study information

• Verified date: May 2015
• Source: Synthes GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

Case series of tibial plateau fractures using Norian Drillable.

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 information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Fractures

Intervention

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

Locations

Country	Name	City	State
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	John Hunter Hospital	New Lambton	New South Wales
China	Queen Mary Hospital	Hong Kong
Netherlands	St. Antonius Ziekenhuis	Nieuwegein
Netherlands	St. Elisabeth Ziekenhuis	Tilburg
Norway	Sykehuset I Vestfold	Tønsberg

Sponsors (2)

Lead Sponsor	Collaborator
Synthes GmbH	Synthes Asia Pacific

Countries where clinical trial is conducted

Australia,  China,  Netherlands,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment	Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the duration of time the patient was in the operating room (OR)	Day 0 (Day of surgery)	Yes
Primary	Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment	Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the estimated amount of blood loss (the amount of fluid used in irrigation should have been subtracted from the amount of fluid present in the suction canister at the completion of surgery. Any gauze used in the procedure should have been estimated for the ml of blood loss)	Day 0 (Day of surgery)	Yes
Primary	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	Yes
Primary	Ease of Use Score Measured With a Surgeon Questionnaire: Drill	Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.	Day 0 (Date of surgery)	No
Primary	Ease of Use Score Measured With a Surgeon Questionnaire: K-wire	Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.; Kirschner wires or K-wires are sterilized, sharpened, smooth stainless steel pins widely used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction in fractures.	Day 0 (Date of surgery)	No
Primary	Ease of Use Score Measured With a Surgeon Questionnaire: Tap	Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.; A tap is an instrument used to create threads in a hole drilled in bone.	Day 0 (Date of surgery)	No
Primary	Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion	Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable.	Day 0 (Date of surgery)	No
Primary	Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing	Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.	Day 0 (Date of surgery)	No
Primary	Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling	Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.	Day 0 (Date of surgery)	No
Primary	Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties	Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.	Day 0 (Date of surgery)	No
Primary	Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure	Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.	Day 0 (Date of surgery)	No
Primary	Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use	Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.	Day 0 (Date of surgery)	No
Primary	Surgeons Overall Satisfaction With Norian Drillable	The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon.	Surgery	No
Secondary	Pain and Function Assessed With the Lysholm Knee Scale	The Lysholm Knee Score assessed pain and function of the knee (by evaluating whether support for weight bearing was needed, the patients ability to climb stairs and to squat, whether the patients knee was instable and the patient experienced pain and swelling) and was completed by the patient before surgery and at Week 6, Week 12, Week 26, Week 52, Week 78 and Week 104 (for Australian sites only). The score ranged from 0 to 100 points with higher values indicating a better healing status of the knee.	6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only)	No
Secondary	Radiographic Parameters: Depression at Baseline	The anatomical grading parameter "depression" was assessed the following way: Anterior-Posterior (AP) and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.	Baseline	No
Secondary	Radiographic Parameters: Depression at Surgery	The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.	Surgery	No
Secondary	Radiographic Parameters: Depression at 6 Weeks	The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.	6 week	No
Secondary	Radiographic Parameters: Depression at 12 Weeks	The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.	12 weeks	No
Secondary	Radiographic Parameters: Depression at 26 Weeks	The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.	26 weeks	No
Secondary	Radiographic Parameters:: Depression at 52 Weeks	The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.	52 weeks	No
Secondary	Radiographic Parameters: Depression at 78 Weeks	The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.	78 weeks	No
Secondary	Radiographic Parameters: Condylar Widening at Baseline	The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.	Baseline	No
Secondary	Radiographic Parameters: Condylar Widening at Surgery	The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.	Surgery	No
Secondary	Radiographic Parameters: Condylar Widening at 6 Weeks	The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.	6 weeks	No
Secondary	Radiographic Parameters: Condylar Widening at 12 Weeks	The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.	12 weeks	No
Secondary	Radiographic Parameters: Condylar Widening at 26 Weeks	The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.	26 weeks	No
Secondary	Radiographic Parameters: Condylar Widening at 52 Weeks	The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.	52 weeks	No
Secondary	Radiographic Parameters: Condylar Widening at 78 Weeks	The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.	78 weeks	No
Secondary	Radiographic Parameters: Angulation (Valgus/Varus) at Baseline	The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.	Baseline	No
Secondary	Radiographic Parameters: Angulation (Valgus/Varus) at Surgery	The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.	Surgery	No
Secondary	Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks	The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.	6 weeks	No
Secondary	Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks	The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.	12 weeks	No
Secondary	Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks	The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.	26 weeks	No
Secondary	Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks	The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.	52 weeks	No
Secondary	Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks	The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.	78 weeks	No
Secondary	Knee Function and Stability: Extension at Baseline	The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.	Baseline	No
Secondary	Knee Function and Stability: Extension at 6 Weeks	The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.	6 weeks	No
Secondary	Knee Function and Stability: Extension at 12 Weeks	The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.	12 weeks	No
Secondary	Knee Function and Stability: Extension at 26 Week	The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.	26 weeks	No
Secondary	Knee Function and Stability: Extension at 52 Weeks	The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.	52 weeks	No
Secondary	Knee Function and Stability: Extension at 78 Weeks	The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.	78 weeks	No
Secondary	Knee Function and Stability: Total Range of Motion at Baseline	Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.	Baseline	No
Secondary	Knee Function and Stability: Total Range of Motion at 6 Weeks	Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.	6 weeks	No
Secondary	Knee Function and Stability: Total Range of Motion at 12 Weeks	Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.	12 weeks	No
Secondary	Knee Function and Stability: Total Range of Motion at 26 Weeks	Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.	26 weeks	No
Secondary	Knee Function and Stability: Total Range of Motion at 52 Weeks	Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.	52 weeks	No
Secondary	Knee Function and Stability: Total Range of Motion at 78 Weeks	Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.	78 weeks	No
Secondary	Knee Function and Stability: Extension Stability at Baseline	Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.	Baseline	No
Secondary	Knee Function and Stability: Extension Stability at 6 Weeks	Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.	6 weeks	No
Secondary	Knee Function and Stability: Extension Stability at 12 Weeks	Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.	12 weeks	No
Secondary	Knee Function and Stability: Extension Stability at 26 Weeks	Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.	26 weeks	No
Secondary	Knee Function and Stability: Extension Stability at 52 Weeks	Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.	52 weeks	No
Secondary	Knee Function and Stability: Extension Stability at 78 Weeks	Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.	78 weeks	No