Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures
26. Mai 2015 aktualisiert von: Synthes GmbH
Case series of tibial plateau fractures using Norian Drillable.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
33
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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New South Wales
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Liverpool, New South Wales, Australien, 2170
- Liverpool Hospital
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New Lambton, New South Wales, Australien, 2305
- John Hunter Hospital
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Hong Kong, China
- Queen Mary Hospital
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Nieuwegein, Niederlande, 3435
- St. Antonius Ziekenhuis
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Tilburg, Niederlande, 5022
- St. Elisabeth Ziekenhuis
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Tønsberg, Norwegen, 3103
- Sykehuset i Vestfold
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
Primary care clinic
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Nur Fall
- Zeitperspektiven: Interessent
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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Behandlung
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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
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Pain and Function Assessed With the Lysholm Knee Scale
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 6 weeks
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The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
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6 weeks
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Radiographic Parameters: Condylar Widening at 12 Weeks
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 52 weeks
|
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
52 weeks
|
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Radiographic Parameters: Condylar Widening at 78 Weeks
Zeitfenster: 78 weeks
|
The anatomical grading parameter "condylar widening" (enlargement of the knee joint) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
78 weeks
|
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Radiographic Parameters: Angulation (Valgus/Varus) at Baseline
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 12 weeks
|
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
12 weeks
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Radiographic Parameters: Angulation (Valgus/Varus) at 26 Weeks
Zeitfenster: 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
|
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Radiographic Parameters: Angulation (Valgus/Varus) at 52 Weeks
Zeitfenster: 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
Zeitfenster: 78 weeks
|
The anatomical grading parameter "angulation (valgus/varus)" (abnormal outward/inward turning of the knee) was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoints.
Additional oblique radiographs at 45° or other fracture imaging was optional.
All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint.
CT scans were only mandatory at Baseline.
|
78 weeks
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Knee Function and Stability: Extension at Baseline
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
|
52 weeks
|
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Knee Function and Stability: Extension at 78 Weeks
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
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Knee Function and Stability: Total Range of Motion at 12 Weeks
Zeitfenster: 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
|
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Knee Function and Stability: Total Range of Motion at 26 Weeks
Zeitfenster: 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
|
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Knee Function and Stability: Total Range of Motion at 52 Weeks
Zeitfenster: 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
Zeitfenster: 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
|
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Knee Function and Stability: Extension Stability at Baseline
Zeitfenster: Baseline
|
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
Baseline
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Knee Function and Stability: Extension Stability at 6 Weeks
Zeitfenster: 6 weeks
|
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
6 weeks
|
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Knee Function and Stability: Extension Stability at 12 Weeks
Zeitfenster: 12 weeks
|
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
12 weeks
|
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Knee Function and Stability: Extension Stability at 26 Weeks
Zeitfenster: 26 weeks
|
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
26 weeks
|
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Knee Function and Stability: Extension Stability at 52 Weeks
Zeitfenster: 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
Zeitfenster: 78 weeks
|
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
|
78 weeks
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Zsolt Balogh, MD, John Hunter Hospital, New Lambton, NSW, Australia
- Hauptermittler: Ian Harris, MD, Liverpool Hospital, Liverpool, NSW, Australia
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. September 2008
Primärer Abschluss (Tatsächlich)
1. September 2013
Studienabschluss (Tatsächlich)
1. September 2013
Studienanmeldedaten
Zuerst eingereicht
16. Februar 2010
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
26. Mai 2010
Zuerst gepostet (Schätzen)
28. Mai 2010
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
11. Juni 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
26. Mai 2015
Zuletzt verifiziert
1. Mai 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ND-AUS-01
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .