Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures
26 maggio 2015 aggiornato da: Synthes GmbH
Case series of tibial plateau fractures using Norian Drillable.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Osservativo
Iscrizione (Effettivo)
33
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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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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-
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-
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Hong Kong, Cina
- Queen Mary Hospital
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-
-
-
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Tønsberg, Norvegia, 3103
- Sykehuset i Vestfold
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-
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Nieuwegein, Olanda, 3435
- St. Antonius Ziekenhuis
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Tilburg, Olanda, 5022
- St. Elisabeth Ziekenhuis
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Primary care clinic
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Solo caso
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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Trattamento
|
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
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment
Lasso di tempo: 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)
|
Day 0 (Day of surgery)
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Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment
Lasso di tempo: 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)
|
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
|
Ease of Use Score Measured With a Surgeon Questionnaire: Tap
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
Day 0 (Date of surgery)
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Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pain and Function Assessed With the Lysholm Knee Scale
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
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Radiographic Parameters: Depression at 6 Weeks
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
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Radiographic Parameters:: Depression at 52 Weeks
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline
|
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
Baseline
|
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Knee Function and Stability: Extension at 6 Weeks
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 78 weeks
|
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
78 weeks
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Zsolt Balogh, MD, John Hunter Hospital, New Lambton, NSW, Australia
- Investigatore principale: Ian Harris, MD, Liverpool Hospital, Liverpool, NSW, Australia
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2008
Completamento primario (Effettivo)
1 settembre 2013
Completamento dello studio (Effettivo)
1 settembre 2013
Date di iscrizione allo studio
Primo inviato
16 febbraio 2010
Primo inviato che soddisfa i criteri di controllo qualità
26 maggio 2010
Primo Inserito (Stima)
28 maggio 2010
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
11 giugno 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
26 maggio 2015
Ultimo verificato
1 maggio 2015
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ND-AUS-01
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .