Trial Outcomes & Findings for Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures (NCT NCT01132508)

NCT ID: NCT01132508

Last Updated: 2015-06-11

Results Overview

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)

• Recruitment status: COMPLETED
• Target enrollment: 33 participants
• Primary outcome timeframe: Day 0 (Day of surgery)
• Results posted on: 2015-06-11

Participant Flow

Participant milestones

Measure	Treatment 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
Overall Study STARTED	33
Overall Study Treated at Baseline	33
Overall Study 6 Weeks	33
Overall Study 12 Weeks	33
Overall Study 26 Weeks	33
Overall Study 52 Weeks	30
Overall Study 78 Weeks	28
Overall Study 104 Weeks	27
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Treatment n=33 Participants 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
Age, Continuous	56.6 Years STANDARD_DEVIATION 15.37 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race/Ethnicity, Customized White	28 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants
Race/Ethnicity, Customized Black	0 participants n=5 Participants
Race/Ethnicity, Customized Indian	0 participants n=5 Participants
Race/Ethnicity, Customized Other	4 participants n=5 Participants
Region of Enrollment Australia	10 participants n=5 Participants
Region of Enrollment Netherlands	6 participants n=5 Participants
Region of Enrollment Norway	16 participants n=5 Participants
Region of Enrollment China	1 participants n=5 Participants
Height (n=32)	169.5 centimeter STANDARD_DEVIATION 9.85 • n=5 Participants
Weight (n=32)	75.5 kilogram STANDARD_DEVIATION 18.33 • n=5 Participants
BMI (n=32)	26.3 kg/m2 STANDARD_DEVIATION 5.78 • n=5 Participants
Exercise per week Never	4 participants n=5 Participants
Exercise per week 1-2 times per week	9 participants n=5 Participants
Exercise per week 3-4 times per week	9 participants n=5 Participants
Exercise per week 5 or more times per week	9 participants n=5 Participants
Exercise per week Missing	2 participants n=5 Participants
Occupation Retired	12 participants n=5 Participants
Occupation Student	0 participants n=5 Participants
Occupation Home worker	2 participants n=5 Participants
Occupation Office worker	1 participants n=5 Participants
Occupation Light industrial or light industrial labor	3 participants n=5 Participants
Occupation Moderate industrial or moderate physical labor	6 participants n=5 Participants
Occupation Heavy industrial or heavy industrial labor	0 participants n=5 Participants
Occupation Other	9 participants n=5 Participants
Health status Excellent	5 participants n=5 Participants
Health status Good	18 participants n=5 Participants
Health status Fair	9 participants n=5 Participants
Health status Poor	0 participants n=5 Participants
Health status Missing	1 participants n=5 Participants
Smoking status Never	11 participants n=5 Participants
Smoking status Former	11 participants n=5 Participants
Smoking status Current	10 participants n=5 Participants
Smoking status Missing	1 participants n=5 Participants
Injury characteristics: side of fracture Right knee	9 participants n=5 Participants
Injury characteristics: side of fracture Left knee	24 participants n=5 Participants
Mechanism of injury Low impact trauma	29 participants n=5 Participants
Mechanism of injury High impact trauma	7 participants n=5 Participants
Mechanism of injury Sports	6 participants n=5 Participants
Orthopaedic Trauma Association (OTA) fracture type B2	5 participants n=5 Participants
Orthopaedic Trauma Association (OTA) fracture type B3	19 participants n=5 Participants
Orthopaedic Trauma Association (OTA) fracture type C3	8 participants n=5 Participants
Orthopaedic Trauma Association (OTA) fracture type Missing	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure

Treatment n=33 Participants 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

Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment

107.0 Minutes Interval 52.0 to 392.0

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure

Treatment n=31 Participants 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

Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment

114.0 Cubic Centimeters Standard Deviation 117.35

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure

Treatment n=33 Participants 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

Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device

21 participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment n=33 Participants 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
Ease of Use Score Measured With a Surgeon Questionnaire: Drill Easy	27 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Drill Moderate	1 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Drill Difficult	0 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Drill n/a	5 Cases

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment n=33 Participants 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
Ease of Use Score Measured With a Surgeon Questionnaire: K-wire Easy	5 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: K-wire Moderate	0 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: K-wire Difficult	0 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: K-wire n/a	28 Cases

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment n=33 Participants 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
Ease of Use Score Measured With a Surgeon Questionnaire: Tap Easy	8 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Tap Moderate	0 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Tap Difficult	0 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Tap n/a	25 Cases

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment n=33 Participants 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
Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion Easy	29 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion Moderate	1 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion Difficult	0 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion n/a	3 Cases

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment n=33 Participants 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
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing Exceptional	6 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing Very easy	16 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing Somewhat easy	3 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing Average	6 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing Fair	1 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing Somewhat difficult	0 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing Very difficult	0 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing Missing	1 Cases

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment n=33 Participants 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
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling Exceptional	4 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling Very easy	15 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling Somewhat easy	6 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling Average	7 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling Fair	0 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling Somewhat difficult	0 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling Very difficult	0 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling Missing	1 Cases

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment n=33 Participants 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
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties Exceptional	6 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties Very easy	9 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties Somewhat easy	10 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties Average	6 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties Fair	0 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties Somewhat difficult	1 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties Very difficult	0 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties Missing	1 Cases

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment n=33 Participants 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
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure Exceptional	2 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure Very easy	15 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure Somewhat easy	6 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure Average	9 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure Fair	0 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure Somewhat difficult	0 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure Very difficult	0 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure Missing	1 Cases

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Treatment n=33 Participants 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
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use Exceptional	6 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use Very easy	11 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use Somewhat easy	10 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use Average	4 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use Fair	0 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use Somewhat difficult	1 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use Very difficult	0 Cases
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use Missing	1 Cases

PRIMARY outcome

Timeframe: Surgery

The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon.

Outcome measures

Measure	Treatment n=33 Participants 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
Surgeons Overall Satisfaction With Norian Drillable Very satisfied	21 Cases
Surgeons Overall Satisfaction With Norian Drillable Satisfied	2 Cases
Surgeons Overall Satisfaction With Norian Drillable Somewhat satisfied	6 Cases
Surgeons Overall Satisfaction With Norian Drillable Average	1 Cases
Surgeons Overall Satisfaction With Norian Drillable Not dissatisfied	0 Cases
Surgeons Overall Satisfaction With Norian Drillable Somewhat dissatisfied	2 Cases
Surgeons Overall Satisfaction With Norian Drillable Very dissatisfied	0 Cases
Surgeons Overall Satisfaction With Norian Drillable Missing	1 Cases

SECONDARY outcome

Timeframe: 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only)

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Pain and Function Assessed With the Lysholm Knee Scale Week 6, n=24	52.0 units on a scale Interval 0.0 to 86.7
Pain and Function Assessed With the Lysholm Knee Scale Week 12, n=23	66.7 units on a scale Interval 20.5 to 92.0
Pain and Function Assessed With the Lysholm Knee Scale Week 26, n=20	70.6 units on a scale Interval 17.5 to 86.1
Pain and Function Assessed With the Lysholm Knee Scale Week 52, n=24	75.0 units on a scale Interval 21.0 to 95.0
Pain and Function Assessed With the Lysholm Knee Scale Week 78, n=21	67.8 units on a scale Interval 20.5 to 92.0
Pain and Function Assessed With the Lysholm Knee Scale Week 104, n=4	73.5 units on a scale Interval 61.0 to 95.0

SECONDARY outcome

Timeframe: Baseline

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Radiographic Parameters: Depression at Baseline Not present	0 participants
Radiographic Parameters: Depression at Baseline Present	27 participants
Radiographic Parameters: Depression at Baseline Missing	1 participants

SECONDARY outcome

Timeframe: Surgery

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Radiographic Parameters: Depression at Surgery Not present	15 participants
Radiographic Parameters: Depression at Surgery Present	12 participants
Radiographic Parameters: Depression at Surgery Missing	1 participants

SECONDARY outcome

Timeframe: 6 week

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Radiographic Parameters: Depression at 6 Weeks Not present	22 participants
Radiographic Parameters: Depression at 6 Weeks Present	4 participants
Radiographic Parameters: Depression at 6 Weeks Missing	2 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Radiographic Parameters: Depression at 12 Weeks Not present	16 participants
Radiographic Parameters: Depression at 12 Weeks Present	7 participants
Radiographic Parameters: Depression at 12 Weeks Missing	5 participants

SECONDARY outcome

Timeframe: 26 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Radiographic Parameters: Depression at 26 Weeks Not present	16 participants
Radiographic Parameters: Depression at 26 Weeks Present	5 participants
Radiographic Parameters: Depression at 26 Weeks Missing	7 participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Radiographic Parameters:: Depression at 52 Weeks Not present	12 participants
Radiographic Parameters:: Depression at 52 Weeks Present	8 participants
Radiographic Parameters:: Depression at 52 Weeks Missing	8 participants

SECONDARY outcome

Timeframe: 78 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Radiographic Parameters: Depression at 78 Weeks Not present	13 participants
Radiographic Parameters: Depression at 78 Weeks Present	8 participants
Radiographic Parameters: Depression at 78 Weeks Missing	7 participants

SECONDARY outcome

Timeframe: Baseline

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Radiographic Parameters: Condylar Widening at Baseline Not present	6 participants
Radiographic Parameters: Condylar Widening at Baseline Present	21 participants
Radiographic Parameters: Condylar Widening at Baseline Missing	1 participants

SECONDARY outcome

Timeframe: Surgery

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Radiographic Parameters: Condylar Widening at Surgery Not present	20 participants
Radiographic Parameters: Condylar Widening at Surgery Present	7 participants
Radiographic Parameters: Condylar Widening at Surgery Missing	1 participants

SECONDARY outcome

Timeframe: 6 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Radiographic Parameters: Condylar Widening at 6 Weeks Not present	24 participants
Radiographic Parameters: Condylar Widening at 6 Weeks Present	2 participants
Radiographic Parameters: Condylar Widening at 6 Weeks Missing	2 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Radiographic Parameters: Condylar Widening at 12 Weeks Not present	23 participants
Radiographic Parameters: Condylar Widening at 12 Weeks Present	0 participants
Radiographic Parameters: Condylar Widening at 12 Weeks Missing	5 participants

SECONDARY outcome

Timeframe: 26 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Radiographic Parameters: Condylar Widening at 26 Weeks Not present	20 participants
Radiographic Parameters: Condylar Widening at 26 Weeks Present	1 participants
Radiographic Parameters: Condylar Widening at 26 Weeks Missing	7 participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Radiographic Parameters: Condylar Widening at 52 Weeks Not present	20 participants
Radiographic Parameters: Condylar Widening at 52 Weeks Present	0 participants
Radiographic Parameters: Condylar Widening at 52 Weeks Missing	8 participants

SECONDARY outcome

Timeframe: 78 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Radiographic Parameters: Condylar Widening at 78 Weeks Not present	20 participants
Radiographic Parameters: Condylar Widening at 78 Weeks Present	0 participants
Radiographic Parameters: Condylar Widening at 78 Weeks Missing	8 participants

SECONDARY outcome

Timeframe: Baseline

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Radiographic Parameters: Angulation (Valgus/Varus) at Baseline Not present	16 participants
Radiographic Parameters: Angulation (Valgus/Varus) at Baseline Present	9 participants
Radiographic Parameters: Angulation (Valgus/Varus) at Baseline Missing	3 participants

SECONDARY outcome

Timeframe: Surgery

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Radiographic Parameters: Angulation (Valgus/Varus) at Surgery Not present	23 participants
Radiographic Parameters: Angulation (Valgus/Varus) at Surgery Present	4 participants
Radiographic Parameters: Angulation (Valgus/Varus) at Surgery Missing	1 participants

SECONDARY outcome

Timeframe: 6 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks Not present	24 participants
Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks Present	2 participants
Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks Missing	2 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks Not present	21 participants
Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks Present	3 participants
Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks Missing	4 participants

SECONDARY outcome

Timeframe: 26 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks Not present	19 participants
Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks Present	2 participants
Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks Missing	7 participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks Not present	17 participants
Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks Present	3 participants
Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks Missing	8 participants

SECONDARY outcome

Timeframe: 78 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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.

Outcome measures

Measure	Treatment n=28 Participants 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
Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks Not present	17 participants
Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks Present	3 participants
Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks Missing	8 participants

SECONDARY outcome

Timeframe: Baseline

Population: Five major protocol violations were excluded in the efficacy analysis.

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

Outcome measures

Measure	Treatment n=28 Participants 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
Knee Function and Stability: Extension at Baseline Normal	16 participants
Knee Function and Stability: Extension at Baseline 0-10 Degrees	10 participants
Knee Function and Stability: Extension at Baseline Missing	2 participants

SECONDARY outcome

Timeframe: 6 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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

Outcome measures

Measure	Treatment n=28 Participants 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
Knee Function and Stability: Extension at 6 Weeks Normal	20 participants
Knee Function and Stability: Extension at 6 Weeks 0-10 Degrees	6 participants
Knee Function and Stability: Extension at 6 Weeks Missing	2 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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

Outcome measures

Measure	Treatment n=28 Participants 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
Knee Function and Stability: Extension at 12 Weeks Normal	21 participants
Knee Function and Stability: Extension at 12 Weeks 0-10 degrees	2 participants
Knee Function and Stability: Extension at 12 Weeks Missing	5 participants

SECONDARY outcome

Timeframe: 26 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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

Outcome measures

Measure	Treatment n=28 Participants 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
Knee Function and Stability: Extension at 26 Week Normal	18 participants
Knee Function and Stability: Extension at 26 Week 0-10 degrees	3 participants
Knee Function and Stability: Extension at 26 Week Missing	7 participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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

Outcome measures

Measure	Treatment n=28 Participants 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
Knee Function and Stability: Extension at 52 Weeks Normal	20 participants
Knee Function and Stability: Extension at 52 Weeks 0-10 degrees	4 participants
Knee Function and Stability: Extension at 52 Weeks Missing	4 participants

SECONDARY outcome

Timeframe: 78 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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

Outcome measures

Measure	Treatment n=28 Participants 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
Knee Function and Stability: Extension at 78 Weeks Normal	19 participants
Knee Function and Stability: Extension at 78 Weeks 0-10 Degrees	2 participants
Knee Function and Stability: Extension at 78 Weeks Missing	7 participants

SECONDARY outcome

Timeframe: Baseline

Population: Five major protocol violations were excluded in the efficacy analysis.

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

Outcome measures

Measure	Treatment n=28 Participants 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
Knee Function and Stability: Total Range of Motion at Baseline At least 140 degrees	3 participants
Knee Function and Stability: Total Range of Motion at Baseline At least 120 degrees	4 participants
Knee Function and Stability: Total Range of Motion at Baseline At least 90 degrees	8 participants
Knee Function and Stability: Total Range of Motion at Baseline At least 60 degrees	5 participants
Knee Function and Stability: Total Range of Motion at Baseline At least 30 degrees	1 participants
Knee Function and Stability: Total Range of Motion at Baseline At least 0-30 degrees	3 participants
Knee Function and Stability: Total Range of Motion at Baseline Missing	4 participants

SECONDARY outcome

Timeframe: 6 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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

Outcome measures

Measure	Treatment n=28 Participants 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
Knee Function and Stability: Total Range of Motion at 6 Weeks At least 140 degrees	4 participants
Knee Function and Stability: Total Range of Motion at 6 Weeks At least 120 degrees	6 participants
Knee Function and Stability: Total Range of Motion at 6 Weeks At least 90 degrees	13 participants
Knee Function and Stability: Total Range of Motion at 6 Weeks At least 60 degrees	2 participants
Knee Function and Stability: Total Range of Motion at 6 Weeks At least 30 degrees	2 participants
Knee Function and Stability: Total Range of Motion at 6 Weeks At least 0-30 degrees	0 participants
Knee Function and Stability: Total Range of Motion at 6 Weeks Missing	1 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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

Outcome measures

Measure	Treatment n=28 Participants 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
Knee Function and Stability: Total Range of Motion at 12 Weeks At least 140 degrees	10 participants
Knee Function and Stability: Total Range of Motion at 12 Weeks At least 120 degrees	9 participants
Knee Function and Stability: Total Range of Motion at 12 Weeks At least 90 degrees	2 participants
Knee Function and Stability: Total Range of Motion at 12 Weeks At least 60 degrees	0 participants
Knee Function and Stability: Total Range of Motion at 12 Weeks At least 30 degrees	2 participants
Knee Function and Stability: Total Range of Motion at 12 Weeks At least 0-30 degrees	0 participants
Knee Function and Stability: Total Range of Motion at 12 Weeks Missing	5 participants

SECONDARY outcome

Timeframe: 26 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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

Outcome measures

Measure	Treatment n=28 Participants 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
Knee Function and Stability: Total Range of Motion at 26 Weeks At least 140 degrees	4 participants
Knee Function and Stability: Total Range of Motion at 26 Weeks At least 120 degrees	11 participants
Knee Function and Stability: Total Range of Motion at 26 Weeks At least 90 degrees	4 participants
Knee Function and Stability: Total Range of Motion at 26 Weeks At least 60 degrees	1 participants
Knee Function and Stability: Total Range of Motion at 26 Weeks At least 30 degrees	1 participants
Knee Function and Stability: Total Range of Motion at 26 Weeks At least 0-30 degrees	0 participants
Knee Function and Stability: Total Range of Motion at 26 Weeks Missing	7 participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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

Outcome measures

Measure	Treatment n=28 Participants 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
Knee Function and Stability: Total Range of Motion at 52 Weeks At least 140 degrees	16 participants
Knee Function and Stability: Total Range of Motion at 52 Weeks At least 120 degrees	5 participants
Knee Function and Stability: Total Range of Motion at 52 Weeks At least 90 degrees	1 participants
Knee Function and Stability: Total Range of Motion at 52 Weeks At least 60 degrees	1 participants
Knee Function and Stability: Total Range of Motion at 52 Weeks At least 30 degrees	1 participants
Knee Function and Stability: Total Range of Motion at 52 Weeks At least 0-30 degrees	0 participants
Knee Function and Stability: Total Range of Motion at 52 Weeks Missing	4 participants

SECONDARY outcome

Timeframe: 78 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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

Outcome measures

Measure	Treatment n=28 Participants 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
Knee Function and Stability: Total Range of Motion at 78 Weeks At least 0-30 degrees	0 participants
Knee Function and Stability: Total Range of Motion at 78 Weeks Missing	7 participants
Knee Function and Stability: Total Range of Motion at 78 Weeks At least 140 degrees	10 participants
Knee Function and Stability: Total Range of Motion at 78 Weeks At least 120 degrees	9 participants
Knee Function and Stability: Total Range of Motion at 78 Weeks At least 90 degrees	0 participants
Knee Function and Stability: Total Range of Motion at 78 Weeks At least 60 degrees	2 participants
Knee Function and Stability: Total Range of Motion at 78 Weeks At least 30 degrees	0 participants

SECONDARY outcome

Timeframe: Baseline

Population: Five major protocol violations were excluded in the efficacy analysis.

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

Outcome measures

Measure	Treatment n=28 Participants 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
Knee Function and Stability: Extension Stability at Baseline Instability in extension >10 degrees	1 participants
Knee Function and Stability: Extension Stability at Baseline Missing	5 participants
Knee Function and Stability: Extension Stability at Baseline Normal stability	13 participants
Knee Function and Stability: Extension Stability at Baseline Abnormal instability	6 participants
Knee Function and Stability: Extension Stability at Baseline Instability in extension <10 degrees	3 participants

SECONDARY outcome

Timeframe: 6 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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

Outcome measures

Measure	Treatment n=28 Participants 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
Knee Function and Stability: Extension Stability at 6 Weeks Normal stability	23 participants
Knee Function and Stability: Extension Stability at 6 Weeks Abnormal instability	3 participants
Knee Function and Stability: Extension Stability at 6 Weeks Instability in extension <10 degrees	1 participants
Knee Function and Stability: Extension Stability at 6 Weeks Instability in extension >10 degrees	0 participants
Knee Function and Stability: Extension Stability at 6 Weeks Missing	1 participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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

Outcome measures

Measure	Treatment n=28 Participants 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
Knee Function and Stability: Extension Stability at 12 Weeks Normal stability	22 participants
Knee Function and Stability: Extension Stability at 12 Weeks Abnormal instability	1 participants
Knee Function and Stability: Extension Stability at 12 Weeks Instability in extension <10 degrees	0 participants
Knee Function and Stability: Extension Stability at 12 Weeks Instability in extension >10 degrees	0 participants
Knee Function and Stability: Extension Stability at 12 Weeks Missing	5 participants

SECONDARY outcome

Timeframe: 26 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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

Outcome measures

Measure	Treatment n=28 Participants 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
Knee Function and Stability: Extension Stability at 26 Weeks Normal stability	20 participants
Knee Function and Stability: Extension Stability at 26 Weeks Abnormal instability	0 participants
Knee Function and Stability: Extension Stability at 26 Weeks Instability in extension <10 degrees	1 participants
Knee Function and Stability: Extension Stability at 26 Weeks Instability in extension >10 degrees	0 participants
Knee Function and Stability: Extension Stability at 26 Weeks Missing	7 participants

SECONDARY outcome

Timeframe: 52 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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

Outcome measures

Measure	Treatment n=28 Participants 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
Knee Function and Stability: Extension Stability at 52 Weeks Normal stability	22 participants
Knee Function and Stability: Extension Stability at 52 Weeks Abnormal instability	1 participants
Knee Function and Stability: Extension Stability at 52 Weeks Instability in extension <10 degrees	1 participants
Knee Function and Stability: Extension Stability at 52 Weeks Instability in extension >10 degrees	0 participants
Knee Function and Stability: Extension Stability at 52 Weeks Missing	4 participants

SECONDARY outcome

Timeframe: 78 weeks

Population: Five major protocol violations were excluded in the efficacy analysis.

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

Outcome measures

Measure	Treatment n=28 Participants 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
Knee Function and Stability: Extension Stability at 78 Weeks Normal stability	17 participants
Knee Function and Stability: Extension Stability at 78 Weeks Abnormal instability	3 participants
Knee Function and Stability: Extension Stability at 78 Weeks Instability in extension <10 degrees	1 participants
Knee Function and Stability: Extension Stability at 78 Weeks Instability in extension >10 degrees	0 participants
Knee Function and Stability: Extension Stability at 78 Weeks Missing	7 participants

Adverse Events

Treatment

Serious events: 15 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment n=33 participants at risk 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
Cardiac disorders AORTIC VALVE STENOSIS	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Cardiac disorders CARDIAC FAILURE	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Cardiac disorders CARDIAC FAILURE CONGESTIVE	6.1% 2/33 • Number of events 2 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Gastrointestinal disorders DIARRHOEA	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Gastrointestinal disorders DUODENAL ULCER	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
General disorders DEVICE EXTRUSION	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
General disorders INFLAMMATION	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
General disorders PAIN	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
General disorders PYREXIA	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
General disorders HEPATIC CIRRHOSIS	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Infections and infestations INFECTION	6.1% 2/33 • Number of events 2 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Infections and infestations OSTEOMYELITIS	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Infections and infestations PNEUMONIA	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Infections and infestations URINARY TRACT INFECTION	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Injury, poisoning and procedural complications FALL	6.1% 2/33 • Number of events 2 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Injury, poisoning and procedural complications FEMUR FRACTURE	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Injury, poisoning and procedural complications LOSS OF ANATOMICAL ALIGNMENT AFTER FRACTURE REDUCTION	6.1% 2/33 • Number of events 2 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Injury, poisoning and procedural complications THORACIC VERTEBRAL FRACTURE	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Musculoskeletal and connective tissue disorders MOBILITY DECREASED	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Musculoskeletal and connective tissue disorders OSTEOLYSIS	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Musculoskeletal and connective tissue disorders OSTEONECROSIS	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Musculoskeletal and connective tissue disorders TENDON PAIN	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Nervous system disorders MULTIPLE SCLEROSIS	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).

Other adverse events

Measure	Treatment n=33 participants at risk 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
Gastrointestinal disorders ABDOMINAL PAIN LOWER	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
General disorders NON-CARDIAC CHEST PAIN	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
General disorders MEDICAL DEVICE PAIN	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
General disorders PAIN	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
General disorders DEVICE EXTRUSION	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Injury, poisoning and procedural complications FALL	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Injury, poisoning and procedural complications LOSS OF ANATOMICAL ALIGNMENT AFTER FRACTURE REDUCTION	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Injury, poisoning and procedural complications MENISCUS INJURY	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Injury, poisoning and procedural complications RIB FRACTURE	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Injury, poisoning and procedural complications WOUND DEHISCENCE	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Injury, poisoning and procedural complications WOUND HAEMORRHAGE	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Musculoskeletal and connective tissue disorders ARTHRALGIA	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Musculoskeletal and connective tissue disorders ARTHRITIS	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Musculoskeletal and connective tissue disorders FRACTURE DELAYED UNION	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	6.1% 2/33 • Number of events 2 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Pregnancy, puerperium and perinatal conditions PREGNANCY	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).
Surgical and medical procedures MEDICAL DEVICE REMOVAL	3.0% 1/33 • Number of events 1 • Adverse events were recorded from baseline (surgery) through the end of the follow-up period at 78 or 104 weeks (Australian sites only).

Additional Information

Clinical Research Scientist

Synthes GmbH

Phone: +41619656592

Email: clinicalaffairs.emea@synthes.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60