Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures
26 de mayo de 2015 actualizado por: Synthes GmbH
Case series of tibial plateau fractures using Norian Drillable.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
33
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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New South Wales
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Liverpool, New South Wales, Australia, 2170
- Liverpool Hospital
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New Lambton, New South Wales, Australia, 2305
- John Hunter Hospital
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Tønsberg, Noruega, 3103
- Sykehuset I Vestfold
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Nieuwegein, Países Bajos, 3435
- St. Antonius Ziekenhuis
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Tilburg, Países Bajos, 5022
- St. Elisabeth Ziekenhuis
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Hong Kong, Porcelana
- Queen Mary Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Primary care clinic
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Solo caso
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Tratamiento
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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
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain and Function Assessed With the Lysholm Knee Scale
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 6 week
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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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6 week
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Radiographic Parameters: Depression at 12 Weeks
Periodo de tiempo: 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
Periodo de tiempo: 26 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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26 weeks
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Radiographic Parameters:: Depression at 52 Weeks
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Surgery
|
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Radiographic Parameters: Angulation (Valgus/Varus) at 6 Weeks
Periodo de tiempo: 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.
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6 weeks
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Radiographic Parameters: Angulation (Valgus/Varus) at 12 Weeks
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Zsolt Balogh, MD, John Hunter Hospital, New Lambton, NSW, Australia
- Investigador principal: Ian Harris, MD, Liverpool Hospital, Liverpool, NSW, Australia
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2008
Finalización primaria (Actual)
1 de septiembre de 2013
Finalización del estudio (Actual)
1 de septiembre de 2013
Fechas de registro del estudio
Enviado por primera vez
16 de febrero de 2010
Primero enviado que cumplió con los criterios de control de calidad
26 de mayo de 2010
Publicado por primera vez (Estimar)
28 de mayo de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
11 de junio de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
26 de mayo de 2015
Última verificación
1 de mayo de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ND-AUS-01
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .