Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures
26 мая 2015 г. обновлено: Synthes GmbH
Case series of tibial plateau fractures using Norian Drillable.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Наблюдательный
Регистрация (Действительный)
33
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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New South Wales
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Liverpool, New South Wales, Австралия, 2170
- Liverpool Hospital
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New Lambton, New South Wales, Австралия, 2305
- John Hunter Hospital
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Hong Kong, Китай
- Queen Mary Hospital
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Nieuwegein, Нидерланды, 3435
- St. Antonius Ziekenhuis
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Tilburg, Нидерланды, 5022
- St. Elisabeth Ziekenhuis
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Tønsberg, Норвегия, 3103
- Sykehuset I Vestfold
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Метод выборки
Невероятностная выборка
Исследуемая популяция
Primary care clinic
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: Только для случая
- Временные перспективы: Перспективный
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
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Уход
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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
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment
Временное ограничение: Day 0 (Day of surgery)
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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)
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Day 0 (Day of surgery)
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Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment
Временное ограничение: Day 0 (Day of surgery)
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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)
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Day 0 (Day of surgery)
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Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device
Временное ограничение: 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
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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
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Ease of Use Score Measured With a Surgeon Questionnaire: Drill
Временное ограничение: Day 0 (Date of surgery)
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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.
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Day 0 (Date of surgery)
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Ease of Use Score Measured With a Surgeon Questionnaire: K-wire
Временное ограничение: 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. |
Day 0 (Date of surgery)
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Ease of Use Score Measured With a Surgeon Questionnaire: Tap
Временное ограничение: Day 0 (Date of surgery)
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Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer three questions about the ease of use of Norian Drillable. A tap is an instrument used to create threads in a hole drilled in bone. |
Day 0 (Date of surgery)
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Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion
Временное ограничение: Day 0 (Date of surgery)
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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.
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Day 0 (Date of surgery)
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Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing
Временное ограничение: Day 0 (Date of surgery)
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Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
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Day 0 (Date of surgery)
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Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling
Временное ограничение: Day 0 (Date of surgery)
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Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
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Day 0 (Date of surgery)
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Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties
Временное ограничение: Day 0 (Date of surgery)
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Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
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Day 0 (Date of surgery)
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Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure
Временное ограничение: Day 0 (Date of surgery)
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Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
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Day 0 (Date of surgery)
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Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use
Временное ограничение: Day 0 (Date of surgery)
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Right after the surgery in which Norian Drillable was implanted, surgeons were required to answer five questions about the product characteristics of Norian Drillable.
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Day 0 (Date of surgery)
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Surgeons Overall Satisfaction With Norian Drillable
Временное ограничение: Surgery
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The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon.
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Surgery
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Pain and Function Assessed With the Lysholm Knee Scale
Временное ограничение: 6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only)
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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.
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6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only)
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Radiographic Parameters: Depression at Baseline
Временное ограничение: Baseline
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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.
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Baseline
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Radiographic Parameters: Depression at Surgery
Временное ограничение: 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.
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Surgery
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Radiographic Parameters: Depression at 6 Weeks
Временное ограничение: 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.
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6 week
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Radiographic Parameters: Depression at 12 Weeks
Временное ограничение: 12 weeks
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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.
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12 weeks
|
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Radiographic Parameters: Depression at 26 Weeks
Временное ограничение: 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.
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26 weeks
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Radiographic Parameters:: Depression at 52 Weeks
Временное ограничение: 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.
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52 weeks
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Radiographic Parameters: Depression at 78 Weeks
Временное ограничение: 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.
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78 weeks
|
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Radiographic Parameters: Condylar Widening at Baseline
Временное ограничение: Baseline
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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.
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Baseline
|
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Radiographic Parameters: Condylar Widening at Surgery
Временное ограничение: Surgery
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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.
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Surgery
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Radiographic Parameters: Condylar Widening at 6 Weeks
Временное ограничение: 6 weeks
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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.
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6 weeks
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Radiographic Parameters: Condylar Widening at 12 Weeks
Временное ограничение: 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.
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12 weeks
|
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Radiographic Parameters: Condylar Widening at 26 Weeks
Временное ограничение: 26 weeks
|
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
26 weeks
|
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Radiographic Parameters: Condylar Widening at 52 Weeks
Временное ограничение: 52 weeks
|
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
52 weeks
|
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Radiographic Parameters: Condylar Widening at 78 Weeks
Временное ограничение: 78 weeks
|
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
78 weeks
|
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Radiographic Parameters: Angulation (Valgus/Varus) at Baseline
Временное ограничение: 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.
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Baseline
|
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Radiographic Parameters: Angulation (Valgus/Varus) at Surgery
Временное ограничение: Surgery
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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.
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Surgery
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Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks
Временное ограничение: 6 weeks
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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.
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6 weeks
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Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks
Временное ограничение: 12 weeks
|
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
12 weeks
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Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks
Временное ограничение: 26 weeks
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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.
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26 weeks
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Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks
Временное ограничение: 52 weeks
|
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
52 weeks
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Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks
Временное ограничение: 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.
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78 weeks
|
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Knee Function and Stability: Extension at Baseline
Временное ограничение: Baseline
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The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
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Baseline
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Knee Function and Stability: Extension at 6 Weeks
Временное ограничение: 6 weeks
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The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
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6 weeks
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Knee Function and Stability: Extension at 12 Weeks
Временное ограничение: 12 weeks
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The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
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12 weeks
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Knee Function and Stability: Extension at 26 Week
Временное ограничение: 26 weeks
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The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
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26 weeks
|
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Knee Function and Stability: Extension at 52 Weeks
Временное ограничение: 52 weeks
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The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
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52 weeks
|
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Knee Function and Stability: Extension at 78 Weeks
Временное ограничение: 78 weeks
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The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
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78 weeks
|
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Knee Function and Stability: Total Range of Motion at Baseline
Временное ограничение: Baseline
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Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
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Baseline
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Knee Function and Stability: Total Range of Motion at 6 Weeks
Временное ограничение: 6 weeks
|
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
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6 weeks
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Knee Function and Stability: Total Range of Motion at 12 Weeks
Временное ограничение: 12 weeks
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Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
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12 weeks
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Knee Function and Stability: Total Range of Motion at 26 Weeks
Временное ограничение: 26 weeks
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Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
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26 weeks
|
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Knee Function and Stability: Total Range of Motion at 52 Weeks
Временное ограничение: 52 weeks
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Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
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52 weeks
|
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Knee Function and Stability: Total Range of Motion at 78 Weeks
Временное ограничение: 78 weeks
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Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
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78 weeks
|
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Knee Function and Stability: Extension Stability at Baseline
Временное ограничение: Baseline
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Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
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Baseline
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Knee Function and Stability: Extension Stability at 6 Weeks
Временное ограничение: 6 weeks
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Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
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6 weeks
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Knee Function and Stability: Extension Stability at 12 Weeks
Временное ограничение: 12 weeks
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Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
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12 weeks
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Knee Function and Stability: Extension Stability at 26 Weeks
Временное ограничение: 26 weeks
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Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
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26 weeks
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Knee Function and Stability: Extension Stability at 52 Weeks
Временное ограничение: 52 weeks
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Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
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52 weeks
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Knee Function and Stability: Extension Stability at 78 Weeks
Временное ограничение: 78 weeks
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Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
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78 weeks
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Следователи
- Главный следователь: Zsolt Balogh, MD, John Hunter Hospital, New Lambton, NSW, Australia
- Главный следователь: Ian Harris, MD, Liverpool Hospital, Liverpool, NSW, Australia
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 сентября 2008 г.
Первичное завершение (Действительный)
1 сентября 2013 г.
Завершение исследования (Действительный)
1 сентября 2013 г.
Даты регистрации исследования
Первый отправленный
16 февраля 2010 г.
Впервые представлено, что соответствует критериям контроля качества
26 мая 2010 г.
Первый опубликованный (Оценивать)
28 мая 2010 г.
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
11 июня 2015 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
26 мая 2015 г.
Последняя проверка
1 мая 2015 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- ND-AUS-01
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .