Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures
2015. május 26. frissítette: Synthes GmbH
Case series of tibial plateau fractures using Norian Drillable.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Megfigyelő
Beiratkozás (Tényleges)
33
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
-
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New South Wales
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Liverpool, New South Wales, Ausztrália, 2170
- Liverpool Hospital
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New Lambton, New South Wales, Ausztrália, 2305
- John Hunter Hospital
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-
-
-
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Nieuwegein, Hollandia, 3435
- St. Antonius Ziekenhuis
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Tilburg, Hollandia, 5022
- St. Elisabeth Ziekenhuis
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-
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-
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Hong Kong, Kína
- Queen Mary Hospital
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-
-
-
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Tønsberg, Norvégia, 3103
- Sykehuset i Vestfold
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év és régebbi (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Mintavételi módszer
Nem valószínűségi minta
Tanulmányi populáció
Primary care clinic
Leírás
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.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Megfigyelési modellek: Csak esetre
- Időperspektívák: Leendő
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
|---|---|
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Kezelés
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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
Más nevek:
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment
Időkeret: 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)
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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
Időkeret: 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)
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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
Időkeret: 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
Időkeret: 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.
|
Day 0 (Date of surgery)
|
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Ease of Use Score Measured With a Surgeon Questionnaire: K-wire
Időkeret: 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
Időkeret: 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. |
Day 0 (Date of surgery)
|
|
Ease of Use Score Measured With a Surgeon Questionnaire: Screw Insertion
Időkeret: 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.
|
Day 0 (Date of surgery)
|
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Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing
Időkeret: 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.
|
Day 0 (Date of surgery)
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Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling
Időkeret: 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.
|
Day 0 (Date of surgery)
|
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Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties
Időkeret: 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.
|
Day 0 (Date of surgery)
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Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure
Időkeret: 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.
|
Day 0 (Date of surgery)
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Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use
Időkeret: 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.
|
Day 0 (Date of surgery)
|
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Surgeons Overall Satisfaction With Norian Drillable
Időkeret: Surgery
|
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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Pain and Function Assessed With the Lysholm Knee Scale
Időkeret: 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.
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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
Időkeret: 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.
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Baseline
|
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Radiographic Parameters: Depression at Surgery
Időkeret: Surgery
|
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
Surgery
|
|
Radiographic Parameters: Depression at 6 Weeks
Időkeret: 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.
|
6 week
|
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Radiographic Parameters: Depression at 12 Weeks
Időkeret: 12 weeks
|
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
12 weeks
|
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Radiographic Parameters: Depression at 26 Weeks
Időkeret: 26 weeks
|
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
26 weeks
|
|
Radiographic Parameters:: Depression at 52 Weeks
Időkeret: 52 weeks
|
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
52 weeks
|
|
Radiographic Parameters: Depression at 78 Weeks
Időkeret: 78 weeks
|
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
78 weeks
|
|
Radiographic Parameters: Condylar Widening at Baseline
Időkeret: Baseline
|
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
Baseline
|
|
Radiographic Parameters: Condylar Widening at Surgery
Időkeret: Surgery
|
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
Surgery
|
|
Radiographic Parameters: Condylar Widening at 6 Weeks
Időkeret: 6 weeks
|
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
6 weeks
|
|
Radiographic Parameters: Condylar Widening at 12 Weeks
Időkeret: 12 weeks
|
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
12 weeks
|
|
Radiographic Parameters: Condylar Widening at 26 Weeks
Időkeret: 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
|
|
Radiographic Parameters: Condylar Widening at 52 Weeks
Időkeret: 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
|
|
Radiographic Parameters: Condylar Widening at 78 Weeks
Időkeret: 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
|
|
Radiographic Parameters: Angulation (Valgus/Varus) at Baseline
Időkeret: Baseline
|
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
Baseline
|
|
Radiographic Parameters: Angulation (Valgus/Varus) at Surgery
Időkeret: Surgery
|
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
Surgery
|
|
Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks
Időkeret: 6 weeks
|
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
6 weeks
|
|
Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks
Időkeret: 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
|
|
Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks
Időkeret: 26 weeks
|
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
26 weeks
|
|
Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks
Időkeret: 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
|
|
Radiographic Parameters: Angulation (Valgus/Varus) at 78 Weeks
Időkeret: 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
|
|
Knee Function and Stability: Extension at Baseline
Időkeret: Baseline
|
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
Baseline
|
|
Knee Function and Stability: Extension at 6 Weeks
Időkeret: 6 weeks
|
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
6 weeks
|
|
Knee Function and Stability: Extension at 12 Weeks
Időkeret: 12 weeks
|
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
12 weeks
|
|
Knee Function and Stability: Extension at 26 Week
Időkeret: 26 weeks
|
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
26 weeks
|
|
Knee Function and Stability: Extension at 52 Weeks
Időkeret: 52 weeks
|
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
52 weeks
|
|
Knee Function and Stability: Extension at 78 Weeks
Időkeret: 78 weeks
|
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
78 weeks
|
|
Knee Function and Stability: Total Range of Motion at Baseline
Időkeret: Baseline
|
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
Baseline
|
|
Knee Function and Stability: Total Range of Motion at 6 Weeks
Időkeret: 6 weeks
|
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
6 weeks
|
|
Knee Function and Stability: Total Range of Motion at 12 Weeks
Időkeret: 12 weeks
|
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
12 weeks
|
|
Knee Function and Stability: Total Range of Motion at 26 Weeks
Időkeret: 26 weeks
|
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
26 weeks
|
|
Knee Function and Stability: Total Range of Motion at 52 Weeks
Időkeret: 52 weeks
|
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
52 weeks
|
|
Knee Function and Stability: Total Range of Motion at 78 Weeks
Időkeret: 78 weeks
|
Total range of motion of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
78 weeks
|
|
Knee Function and Stability: Extension Stability at Baseline
Időkeret: Baseline
|
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
Baseline
|
|
Knee Function and Stability: Extension Stability at 6 Weeks
Időkeret: 6 weeks
|
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
6 weeks
|
|
Knee Function and Stability: Extension Stability at 12 Weeks
Időkeret: 12 weeks
|
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
12 weeks
|
|
Knee Function and Stability: Extension Stability at 26 Weeks
Időkeret: 26 weeks
|
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
26 weeks
|
|
Knee Function and Stability: Extension Stability at 52 Weeks
Időkeret: 52 weeks
|
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
52 weeks
|
|
Knee Function and Stability: Extension Stability at 78 Weeks
Időkeret: 78 weeks
|
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
78 weeks
|
Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Zsolt Balogh, MD, John Hunter Hospital, New Lambton, NSW, Australia
- Kutatásvezető: Ian Harris, MD, Liverpool Hospital, Liverpool, NSW, Australia
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2008. szeptember 1.
Elsődleges befejezés (Tényleges)
2013. szeptember 1.
A tanulmány befejezése (Tényleges)
2013. szeptember 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2010. február 16.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2010. május 26.
Első közzététel (Becslés)
2010. május 28.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
2015. június 11.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2015. május 26.
Utolsó ellenőrzés
2015. május 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- ND-AUS-01
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .