Tibial Fractures
Conditions
Keywords
Tibial plateau fracture, Orthopaedic Trauma Association (OTA) B2 B3 C3, Bone Void
Brief summary
Case series of tibial plateau fractures using Norian Drillable.
Detailed description
This study is a multi-center, non-randomized prospective case series of tibial plateau fractures using Norian Drillable to fill bone voids, to evaluate OR time, blood loss, complications, ease of use, fracture stabilization and patient function and pain over time.
Interventions
DEVICENorian 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
Sponsors
Synthes Asia Pacific
Synthes GmbH
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment | Day 0 (Day of surgery) | Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the duration of time the patient was in the operating room (OR) |
| Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment | Day 0 (Day of surgery) | Immediately after the surgery in which Norian Drillable was implanted, the surgeon completed a questionnaire in which he recorded the estimated amount of blood loss (the amount of fluid used in irrigation should have been subtracted from the amount of fluid present in the suction canister at the completion of surgery. Any gauze used in the procedure should have been estimated for the ml of blood loss) |
| Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device | At enrolment (between day -7 and day 0), day 0 (day of surgery), 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 (for Australian sites only) postoperative | — |
| Ease of Use Score Measured With a Surgeon Questionnaire: Drill | Day 0 (Date of surgery) | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable. |
| Ease of Use Score Measured With a Surgeon Questionnaire: K-wire | Day 0 (Date of surgery) | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable. Kirschner wires or K-wires are sterilized, sharpened, smooth stainless steel pins widely used to hold bone fragments together (pin fixation) or to provide an anchor for skeletal traction in fractures. |
| Ease of Use Score Measured With a Surgeon Questionnaire: Tap | Day 0 (Date of surgery) | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable. A tap is an instrument used to create threads in a hole drilled in bone. |
| Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion | Day 0 (Date of surgery) | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable. |
| Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing | Day 0 (Date of surgery) | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable. |
| Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling | Day 0 (Date of surgery) | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable. |
| Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties | Day 0 (Date of surgery) | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable. |
| Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure | Day 0 (Date of surgery) | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable. |
| Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use | Day 0 (Date of surgery) | Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable. |
| Surgeons Overall Satisfaction With Norian Drillable | Surgery | The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Parameters: Condylar Widening at 12 Weeks | 12 weeks | The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. |
| Radiographic Parameters: Condylar Widening at 26 Weeks | 26 weeks | The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. |
| Radiographic Parameters: Condylar Widening at 52 Weeks | 52 weeks | The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. |
| Radiographic Parameters: Condylar Widening at 78 Weeks | 78 weeks | The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. |
| Radiographic Parameters: Angulation (Valgus/Varus) at Baseline | Baseline | The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. |
| Radiographic Parameters: Angulation (Valgus/Varus) at Surgery | Surgery | The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. |
| Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks | 6 weeks | The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. |
| Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks | 12 weeks | The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. |
| Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks | 26 weeks | The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. |
| Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks | 52 weeks | The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. |
| Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks | 78 weeks | The anatomical grading parameter angulation (valgus/varus) (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. |
| Knee Function and Stability: Extension at Baseline | Baseline | The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. |
| Knee Function and Stability: Extension at 6 Weeks | 6 weeks | The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. |
| Knee Function and Stability: Extension at 12 Weeks | 12 weeks | The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. |
| Knee Function and Stability: Extension at 26 Week | 26 weeks | The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. |
| Knee Function and Stability: Extension at 52 Weeks | 52 weeks | The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. |
| Knee Function and Stability: Extension at 78 Weeks | 78 weeks | The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. |
| Knee Function and Stability: Total Range of Motion at Baseline | Baseline | Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. |
| Knee Function and Stability: Total Range of Motion at 6 Weeks | 6 weeks | Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. |
| Knee Function and Stability: Extension Stability at 52 Weeks | 52 weeks | Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit. |
| Knee Function and Stability: Total Range of Motion at 26 Weeks | 26 weeks | Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. |
| Knee Function and Stability: Total Range of Motion at 52 Weeks | 52 weeks | Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. |
| Knee Function and Stability: Total Range of Motion at 78 Weeks | 78 weeks | Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. |
| Knee Function and Stability: Extension Stability at Baseline | Baseline | Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit. |
| Knee Function and Stability: Extension Stability at 6 Weeks | 6 weeks | Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit. |
| Knee Function and Stability: Extension Stability at 12 Weeks | 12 weeks | Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit. |
| Knee Function and Stability: Extension Stability at 26 Weeks | 26 weeks | Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit. |
| Knee Function and Stability: Total Range of Motion at 12 Weeks | 12 weeks | Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit. |
| Knee Function and Stability: Extension Stability at 78 Weeks | 78 weeks | Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit. |
| Pain and Function Assessed With the Lysholm Knee Scale | 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only) | The Lysholm Knee Score assessed pain and function of the knee (by evaluating whether support for weight bearing was needed, the patients ability to climb stairs and to squat, whether the patients knee was instable and the patient experienced pain and swelling) and was completed by the patient before surgery and at Week 6, Week 12, Week 26, Week 52, Week 78 and Week 104 (for Australian sites only). The score ranged from 0 to 100 points with higher values indicating a better healing status of the knee. |
| Radiographic Parameters: Depression at Baseline | Baseline | The anatomical grading parameter depression was assessed the following way: Anterior-Posterior (AP) and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. |
| Radiographic Parameters: Depression at Surgery | Surgery | The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. |
| Radiographic Parameters: Depression at 6 Weeks | 6 week | The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. |
| Radiographic Parameters: Depression at 12 Weeks | 12 weeks | The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. |
| Radiographic Parameters: Depression at 26 Weeks | 26 weeks | The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. |
| Radiographic Parameters:: Depression at 52 Weeks | 52 weeks | The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. |
| Radiographic Parameters: Depression at 78 Weeks | 78 weeks | The anatomical grading parameter depression was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. |
| Radiographic Parameters: Condylar Widening at Baseline | Baseline | The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. |
| Radiographic Parameters: Condylar Widening at Surgery | Surgery | The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. |
| Radiographic Parameters: Condylar Widening at 6 Weeks | 6 weeks | The anatomical grading parameter condylar widening (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline. |
Countries
Australia, China, Netherlands, Norway
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Continuous | 56.6 Years STANDARD_DEVIATION 15.37 |
| BMI (n=32) | 26.3 kg/m2 STANDARD_DEVIATION 5.78 |
| Exercise per week 1-2 times per week | 9 participants |
| Exercise per week 3-4 times per week | 9 participants |
| Exercise per week 5 or more times per week | 9 participants |
| Exercise per week Missing | 2 participants |
| Exercise per week Never | 4 participants |
| Health status Excellent | 5 participants |
| Health status Fair | 9 participants |
| Health status Good | 18 participants |
| Health status Missing | 1 participants |
| Health status Poor | 0 participants |
| Height (n=32) | 169.5 centimeter STANDARD_DEVIATION 9.85 |
| Injury characteristics: side of fracture Left knee | 24 participants |
| Injury characteristics: side of fracture Right knee | 9 participants |
| Mechanism of injury High impact trauma | 7 participants |
| Mechanism of injury Low impact trauma | 29 participants |
| Mechanism of injury Sports | 6 participants |
| Occupation Heavy industrial or heavy industrial labor | 0 participants |
| Occupation Home worker | 2 participants |
| Occupation Light industrial or light industrial labor | 3 participants |
| Occupation Moderate industrial or moderate physical labor | 6 participants |
| Occupation Office worker | 1 participants |
| Occupation Other | 9 participants |
| Occupation Retired | 12 participants |
| Occupation Student | 0 participants |
| Orthopaedic Trauma Association (OTA) fracture type B2 | 5 participants |
| Orthopaedic Trauma Association (OTA) fracture type B3 | 19 participants |
| Orthopaedic Trauma Association (OTA) fracture type C3 | 8 participants |
| Orthopaedic Trauma Association (OTA) fracture type Missing | 1 participants |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Black | 0 participants |
| Race/Ethnicity, Customized Indian | 0 participants |
| Race/Ethnicity, Customized Other | 4 participants |
| Race/Ethnicity, Customized White | 28 participants |
| Region of Enrollment Australia | 10 participants |
| Region of Enrollment China | 1 participants |
| Region of Enrollment Netherlands | 6 participants |
| Region of Enrollment Norway | 16 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 13 Participants |
| Smoking status Current | 10 participants |
| Smoking status Former | 11 participants |
| Smoking status Missing | 1 participants |
| Smoking status Never | 11 participants |
| Weight (n=32) | 75.5 kilogram STANDARD_DEVIATION 18.33 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 33 |
| serious Total, serious adverse events | 15 / 33 |
Outcome results
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)
Time frame: Day 0 (Day of surgery)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment | Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment | 107.0 Minutes |
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.
Time frame: Day 0 (Date of surgery)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Drill | Easy | 27 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Drill | Moderate | 1 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Drill | Difficult | 0 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Drill | n/a | 5 Cases |
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.
Time frame: Day 0 (Date of surgery)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: K-wire | Easy | 5 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: K-wire | Moderate | 0 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: K-wire | Difficult | 0 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: K-wire | n/a | 28 Cases |
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.
Time frame: Day 0 (Date of surgery)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure | Exceptional | 2 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure | Very easy | 15 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure | Somewhat easy | 6 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure | Average | 9 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure | Fair | 0 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure | Somewhat difficult | 0 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure | Very difficult | 0 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure | Missing | 1 Cases |
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.
Time frame: Day 0 (Date of surgery)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties | Exceptional | 6 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties | Very easy | 9 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties | Somewhat easy | 10 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties | Average | 6 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties | Fair | 0 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties | Somewhat difficult | 1 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties | Very difficult | 0 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties | Missing | 1 Cases |
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.
Time frame: Day 0 (Date of surgery)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling | Exceptional | 4 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling | Very easy | 15 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling | Somewhat easy | 6 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling | Average | 7 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling | Fair | 0 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling | Somewhat difficult | 0 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling | Very difficult | 0 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling | Missing | 1 Cases |
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.
Time frame: Day 0 (Date of surgery)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing | Exceptional | 6 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing | Very easy | 16 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing | Somewhat easy | 3 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing | Average | 6 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing | Fair | 1 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing | Somewhat difficult | 0 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing | Very difficult | 0 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing | Missing | 1 Cases |
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.
Time frame: Day 0 (Date of surgery)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use | Exceptional | 6 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use | Very easy | 11 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use | Somewhat easy | 10 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use | Average | 4 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use | Fair | 0 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use | Somewhat difficult | 1 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use | Very difficult | 0 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use | Missing | 1 Cases |
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.
Time frame: Day 0 (Date of surgery)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion | Easy | 29 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion | Moderate | 1 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion | Difficult | 0 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion | n/a | 3 Cases |
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.
Time frame: Day 0 (Date of surgery)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Tap | Easy | 8 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Tap | Moderate | 0 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Tap | Difficult | 0 Cases |
| Treatment | Ease of Use Score Measured With a Surgeon Questionnaire: Tap | n/a | 25 Cases |
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)
Time frame: Day 0 (Day of surgery)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment | 114.0 Cubic Centimeters | Standard Deviation 117.35 |
Primary
Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device
Time frame: At enrolment (between day -7 and day 0), day 0 (day of surgery), 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 (for Australian sites only) postoperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device | 21 participants |
Primary
Surgeons Overall Satisfaction With Norian Drillable
The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon.
Time frame: Surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Surgeons Overall Satisfaction With Norian Drillable | Very satisfied | 21 Cases |
| Treatment | Surgeons Overall Satisfaction With Norian Drillable | Satisfied | 2 Cases |
| Treatment | Surgeons Overall Satisfaction With Norian Drillable | Somewhat satisfied | 6 Cases |
| Treatment | Surgeons Overall Satisfaction With Norian Drillable | Average | 1 Cases |
| Treatment | Surgeons Overall Satisfaction With Norian Drillable | Not dissatisfied | 0 Cases |
| Treatment | Surgeons Overall Satisfaction With Norian Drillable | Somewhat dissatisfied | 2 Cases |
| Treatment | Surgeons Overall Satisfaction With Norian Drillable | Very dissatisfied | 0 Cases |
| Treatment | Surgeons Overall Satisfaction With Norian Drillable | Missing | 1 Cases |
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.
Time frame: 12 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Knee Function and Stability: Extension at 12 Weeks | Normal | 21 participants |
| Treatment | Knee Function and Stability: Extension at 12 Weeks | 0-10 degrees | 2 participants |
| Treatment | Knee Function and Stability: Extension at 12 Weeks | Missing | 5 participants |
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.
Time frame: 26 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Knee Function and Stability: Extension at 26 Week | Normal | 18 participants |
| Treatment | Knee Function and Stability: Extension at 26 Week | 0-10 degrees | 3 participants |
| Treatment | Knee Function and Stability: Extension at 26 Week | Missing | 7 participants |
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.
Time frame: 52 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Knee Function and Stability: Extension at 52 Weeks | Normal | 20 participants |
| Treatment | Knee Function and Stability: Extension at 52 Weeks | 0-10 degrees | 4 participants |
| Treatment | Knee Function and Stability: Extension at 52 Weeks | Missing | 4 participants |
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.
Time frame: 6 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Knee Function and Stability: Extension at 6 Weeks | Normal | 20 participants |
| Treatment | Knee Function and Stability: Extension at 6 Weeks | 0-10 Degrees | 6 participants |
| Treatment | Knee Function and Stability: Extension at 6 Weeks | Missing | 2 participants |
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.
Time frame: 78 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Knee Function and Stability: Extension at 78 Weeks | Missing | 7 participants |
| Treatment | Knee Function and Stability: Extension at 78 Weeks | Normal | 19 participants |
| Treatment | Knee Function and Stability: Extension at 78 Weeks | 0-10 Degrees | 2 participants |
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.
Time frame: Baseline
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Knee Function and Stability: Extension at Baseline | Normal | 16 participants |
| Treatment | Knee Function and Stability: Extension at Baseline | 0-10 Degrees | 10 participants |
| Treatment | Knee Function and Stability: Extension at Baseline | Missing | 2 participants |
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.
Time frame: 12 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Knee Function and Stability: Extension Stability at 12 Weeks | Normal stability | 22 participants |
| Treatment | Knee Function and Stability: Extension Stability at 12 Weeks | Abnormal instability | 1 participants |
| Treatment | Knee Function and Stability: Extension Stability at 12 Weeks | Instability in extension <10 degrees | 0 participants |
| Treatment | Knee Function and Stability: Extension Stability at 12 Weeks | Instability in extension >10 degrees | 0 participants |
| Treatment | Knee Function and Stability: Extension Stability at 12 Weeks | Missing | 5 participants |
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.
Time frame: 26 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Knee Function and Stability: Extension Stability at 26 Weeks | Normal stability | 20 participants |
| Treatment | Knee Function and Stability: Extension Stability at 26 Weeks | Abnormal instability | 0 participants |
| Treatment | Knee Function and Stability: Extension Stability at 26 Weeks | Instability in extension <10 degrees | 1 participants |
| Treatment | Knee Function and Stability: Extension Stability at 26 Weeks | Instability in extension >10 degrees | 0 participants |
| Treatment | Knee Function and Stability: Extension Stability at 26 Weeks | Missing | 7 participants |
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.
Time frame: 52 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Knee Function and Stability: Extension Stability at 52 Weeks | Normal stability | 22 participants |
| Treatment | Knee Function and Stability: Extension Stability at 52 Weeks | Abnormal instability | 1 participants |
| Treatment | Knee Function and Stability: Extension Stability at 52 Weeks | Instability in extension <10 degrees | 1 participants |
| Treatment | Knee Function and Stability: Extension Stability at 52 Weeks | Instability in extension >10 degrees | 0 participants |
| Treatment | Knee Function and Stability: Extension Stability at 52 Weeks | Missing | 4 participants |
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.
Time frame: 6 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Knee Function and Stability: Extension Stability at 6 Weeks | Abnormal instability | 3 participants |
| Treatment | Knee Function and Stability: Extension Stability at 6 Weeks | Normal stability | 23 participants |
| Treatment | Knee Function and Stability: Extension Stability at 6 Weeks | Instability in extension <10 degrees | 1 participants |
| Treatment | Knee Function and Stability: Extension Stability at 6 Weeks | Instability in extension >10 degrees | 0 participants |
| Treatment | Knee Function and Stability: Extension Stability at 6 Weeks | Missing | 1 participants |
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.
Time frame: 78 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Knee Function and Stability: Extension Stability at 78 Weeks | Normal stability | 17 participants |
| Treatment | Knee Function and Stability: Extension Stability at 78 Weeks | Abnormal instability | 3 participants |
| Treatment | Knee Function and Stability: Extension Stability at 78 Weeks | Instability in extension <10 degrees | 1 participants |
| Treatment | Knee Function and Stability: Extension Stability at 78 Weeks | Instability in extension >10 degrees | 0 participants |
| Treatment | Knee Function and Stability: Extension Stability at 78 Weeks | Missing | 7 participants |
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.
Time frame: Baseline
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Knee Function and Stability: Extension Stability at Baseline | Normal stability | 13 participants |
| Treatment | Knee Function and Stability: Extension Stability at Baseline | Abnormal instability | 6 participants |
| Treatment | Knee Function and Stability: Extension Stability at Baseline | Instability in extension <10 degrees | 3 participants |
| Treatment | Knee Function and Stability: Extension Stability at Baseline | Instability in extension >10 degrees | 1 participants |
| Treatment | Knee Function and Stability: Extension Stability at Baseline | Missing | 5 participants |
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.
Time frame: 12 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Knee Function and Stability: Total Range of Motion at 12 Weeks | At least 140 degrees | 10 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 12 Weeks | At least 120 degrees | 9 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 12 Weeks | At least 90 degrees | 2 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 12 Weeks | At least 60 degrees | 0 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 12 Weeks | At least 30 degrees | 2 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 12 Weeks | At least 0-30 degrees | 0 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 12 Weeks | Missing | 5 participants |
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.
Time frame: 26 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Knee Function and Stability: Total Range of Motion at 26 Weeks | At least 140 degrees | 4 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 26 Weeks | At least 120 degrees | 11 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 26 Weeks | At least 90 degrees | 4 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 26 Weeks | At least 60 degrees | 1 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 26 Weeks | At least 30 degrees | 1 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 26 Weeks | At least 0-30 degrees | 0 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 26 Weeks | Missing | 7 participants |
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.
Time frame: 52 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Knee Function and Stability: Total Range of Motion at 52 Weeks | At least 140 degrees | 16 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 52 Weeks | At least 120 degrees | 5 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 52 Weeks | At least 90 degrees | 1 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 52 Weeks | At least 60 degrees | 1 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 52 Weeks | At least 30 degrees | 1 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 52 Weeks | At least 0-30 degrees | 0 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 52 Weeks | Missing | 4 participants |
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.
Time frame: 6 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Knee Function and Stability: Total Range of Motion at 6 Weeks | At least 140 degrees | 4 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 6 Weeks | At least 120 degrees | 6 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 6 Weeks | At least 90 degrees | 13 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 6 Weeks | At least 60 degrees | 2 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 6 Weeks | At least 30 degrees | 2 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 6 Weeks | At least 0-30 degrees | 0 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 6 Weeks | Missing | 1 participants |
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.
Time frame: 78 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Knee Function and Stability: Total Range of Motion at 78 Weeks | At least 120 degrees | 9 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 78 Weeks | At least 90 degrees | 0 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 78 Weeks | At least 60 degrees | 2 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 78 Weeks | At least 30 degrees | 0 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 78 Weeks | At least 0-30 degrees | 0 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 78 Weeks | Missing | 7 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at 78 Weeks | At least 140 degrees | 10 participants |
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.
Time frame: Baseline
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Knee Function and Stability: Total Range of Motion at Baseline | At least 140 degrees | 3 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at Baseline | At least 120 degrees | 4 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at Baseline | At least 90 degrees | 8 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at Baseline | At least 60 degrees | 5 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at Baseline | At least 30 degrees | 1 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at Baseline | At least 0-30 degrees | 3 participants |
| Treatment | Knee Function and Stability: Total Range of Motion at Baseline | Missing | 4 participants |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment | Pain and Function Assessed With the Lysholm Knee Scale | Week 26, n=20 | 70.6 units on a scale |
| Treatment | Pain and Function Assessed With the Lysholm Knee Scale | Week 6, n=24 | 52.0 units on a scale |
| Treatment | Pain and Function Assessed With the Lysholm Knee Scale | Week 12, n=23 | 66.7 units on a scale |
| Treatment | Pain and Function Assessed With the Lysholm Knee Scale | Week 52, n=24 | 75.0 units on a scale |
| Treatment | Pain and Function Assessed With the Lysholm Knee Scale | Week 78, n=21 | 67.8 units on a scale |
| Treatment | Pain and Function Assessed With the Lysholm Knee Scale | Week 104, n=4 | 73.5 units on a scale |
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.
Time frame: 12 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks | Not present | 21 participants |
| Treatment | Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks | Present | 3 participants |
| Treatment | Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks | Missing | 4 participants |
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.
Time frame: 26 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks | Not present | 19 participants |
| Treatment | Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks | Present | 2 participants |
| Treatment | Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks | Missing | 7 participants |
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.
Time frame: 52 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks | Not present | 17 participants |
| Treatment | Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks | Present | 3 participants |
| Treatment | Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks | Missing | 8 participants |
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.
Time frame: 6 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks | Not present | 24 participants |
| Treatment | Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks | Present | 2 participants |
| Treatment | Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks | Missing | 2 participants |
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.
Time frame: 78 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks | Not present | 17 participants |
| Treatment | Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks | Present | 3 participants |
| Treatment | Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks | Missing | 8 participants |
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.
Time frame: Baseline
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Radiographic Parameters: Angulation (Valgus/Varus) at Baseline | Not present | 16 participants |
| Treatment | Radiographic Parameters: Angulation (Valgus/Varus) at Baseline | Present | 9 participants |
| Treatment | Radiographic Parameters: Angulation (Valgus/Varus) at Baseline | Missing | 3 participants |
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.
Time frame: Surgery
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Radiographic Parameters: Angulation (Valgus/Varus) at Surgery | Not present | 23 participants |
| Treatment | Radiographic Parameters: Angulation (Valgus/Varus) at Surgery | Present | 4 participants |
| Treatment | Radiographic Parameters: Angulation (Valgus/Varus) at Surgery | Missing | 1 participants |
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.
Time frame: 12 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Radiographic Parameters: Condylar Widening at 12 Weeks | Not present | 23 participants |
| Treatment | Radiographic Parameters: Condylar Widening at 12 Weeks | Present | 0 participants |
| Treatment | Radiographic Parameters: Condylar Widening at 12 Weeks | Missing | 5 participants |
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.
Time frame: 26 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Radiographic Parameters: Condylar Widening at 26 Weeks | Not present | 20 participants |
| Treatment | Radiographic Parameters: Condylar Widening at 26 Weeks | Present | 1 participants |
| Treatment | Radiographic Parameters: Condylar Widening at 26 Weeks | Missing | 7 participants |
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.
Time frame: 52 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Radiographic Parameters: Condylar Widening at 52 Weeks | Not present | 20 participants |
| Treatment | Radiographic Parameters: Condylar Widening at 52 Weeks | Present | 0 participants |
| Treatment | Radiographic Parameters: Condylar Widening at 52 Weeks | Missing | 8 participants |
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.
Time frame: 6 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Radiographic Parameters: Condylar Widening at 6 Weeks | Not present | 24 participants |
| Treatment | Radiographic Parameters: Condylar Widening at 6 Weeks | Present | 2 participants |
| Treatment | Radiographic Parameters: Condylar Widening at 6 Weeks | Missing | 2 participants |
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.
Time frame: 78 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Radiographic Parameters: Condylar Widening at 78 Weeks | Not present | 20 participants |
| Treatment | Radiographic Parameters: Condylar Widening at 78 Weeks | Present | 0 participants |
| Treatment | Radiographic Parameters: Condylar Widening at 78 Weeks | Missing | 8 participants |
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.
Time frame: Baseline
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Radiographic Parameters: Condylar Widening at Baseline | Not present | 6 participants |
| Treatment | Radiographic Parameters: Condylar Widening at Baseline | Present | 21 participants |
| Treatment | Radiographic Parameters: Condylar Widening at Baseline | Missing | 1 participants |
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.
Time frame: Surgery
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Radiographic Parameters: Condylar Widening at Surgery | Not present | 20 participants |
| Treatment | Radiographic Parameters: Condylar Widening at Surgery | Present | 7 participants |
| Treatment | Radiographic Parameters: Condylar Widening at Surgery | Missing | 1 participants |
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.
Time frame: 12 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Radiographic Parameters: Depression at 12 Weeks | Not present | 16 participants |
| Treatment | Radiographic Parameters: Depression at 12 Weeks | Present | 7 participants |
| Treatment | Radiographic Parameters: Depression at 12 Weeks | Missing | 5 participants |
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.
Time frame: 26 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Radiographic Parameters: Depression at 26 Weeks | Not present | 16 participants |
| Treatment | Radiographic Parameters: Depression at 26 Weeks | Present | 5 participants |
| Treatment | Radiographic Parameters: Depression at 26 Weeks | Missing | 7 participants |
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.
Time frame: 52 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Radiographic Parameters:: Depression at 52 Weeks | Not present | 12 participants |
| Treatment | Radiographic Parameters:: Depression at 52 Weeks | Present | 8 participants |
| Treatment | Radiographic Parameters:: Depression at 52 Weeks | Missing | 8 participants |
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.
Time frame: 6 week
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Radiographic Parameters: Depression at 6 Weeks | Not present | 22 participants |
| Treatment | Radiographic Parameters: Depression at 6 Weeks | Present | 4 participants |
| Treatment | Radiographic Parameters: Depression at 6 Weeks | Missing | 2 participants |
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.
Time frame: 78 weeks
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Radiographic Parameters: Depression at 78 Weeks | Not present | 13 participants |
| Treatment | Radiographic Parameters: Depression at 78 Weeks | Present | 8 participants |
| Treatment | Radiographic Parameters: Depression at 78 Weeks | Missing | 7 participants |
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.
Time frame: Baseline
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Radiographic Parameters: Depression at Baseline | Not present | 0 participants |
| Treatment | Radiographic Parameters: Depression at Baseline | Present | 27 participants |
| Treatment | Radiographic Parameters: Depression at Baseline | Missing | 1 participants |
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.
Time frame: Surgery
Population: Five major protocol violations were excluded in the efficacy analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment | Radiographic Parameters: Depression at Surgery | Not present | 15 participants |
| Treatment | Radiographic Parameters: Depression at Surgery | Present | 12 participants |
| Treatment | Radiographic Parameters: Depression at Surgery | Missing | 1 participants |