Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures
2015년 5월 26일 업데이트: Synthes GmbH
Case series of tibial plateau fractures using Norian Drillable.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (실제)
33
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Nieuwegein, 네덜란드, 3435
- St. Antonius Ziekenhuis
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Tilburg, 네덜란드, 5022
- St. Elisabeth Ziekenhuis
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Tønsberg, 노르웨이, 3103
- Sykehuset i Vestfold
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Hong Kong, 중국
- Queen Mary Hospital
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New South Wales
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Liverpool, New South Wales, 호주, 2170
- Liverpool Hospital
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New Lambton, New South Wales, 호주, 2305
- John Hunter Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Primary care clinic
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 전용
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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치료
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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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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. 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pain and Function Assessed With the Lysholm Knee Scale
기간: 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
기간: 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
기간: Surgery
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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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Surgery
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Radiographic Parameters: Depression at 6 Weeks
기간: 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
기간: 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.
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12 weeks
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Radiographic Parameters: Depression at 26 Weeks
기간: 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
기간: 52 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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52 weeks
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Radiographic Parameters: Depression at 78 Weeks
기간: 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
기간: 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
기간: 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.
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Surgery
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Radiographic Parameters: Condylar Widening at 6 Weeks
기간: 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.
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6 weeks
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Radiographic Parameters: Condylar Widening at 12 Weeks
기간: 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
기간: 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.
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26 weeks
|
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Radiographic Parameters: Condylar Widening at 52 Weeks
기간: 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.
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52 weeks
|
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Radiographic Parameters: Condylar Widening at 78 Weeks
기간: 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.
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78 weeks
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Radiographic Parameters: Angulation (Valgus/Varus) at Baseline
기간: Baseline
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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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Baseline
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Radiographic Parameters: Angulation (Valgus/Varus) at Surgery
기간: 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
기간: 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
기간: 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.
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12 weeks
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Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks
기간: 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.
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26 weeks
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Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks
기간: 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
기간: 78 weeks
|
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
78 weeks
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Knee Function and Stability: Extension at Baseline
기간: 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
기간: 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
기간: 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
기간: 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
기간: 52 weeks
|
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
기간: 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
기간: 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
기간: 6 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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6 weeks
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Knee Function and Stability: Total Range of Motion at 12 Weeks
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 26 weeks
|
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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Zsolt Balogh, MD, John Hunter Hospital, New Lambton, NSW, Australia
- 수석 연구원: Ian Harris, MD, Liverpool Hospital, Liverpool, NSW, Australia
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2008년 9월 1일
기본 완료 (실제)
2013년 9월 1일
연구 완료 (실제)
2013년 9월 1일
연구 등록 날짜
최초 제출
2010년 2월 16일
QC 기준을 충족하는 최초 제출
2010년 5월 26일
처음 게시됨 (추정)
2010년 5월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 6월 11일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 5월 26일
마지막으로 확인됨
2015년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- ND-AUS-01
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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