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Use of a Reinforced Injectable Calcium Phosphate Bone Cement in the Treatment of Tibial Plateau Fractures

26 mei 2015 bijgewerkt door: Synthes GmbH
Case series of tibial plateau fractures using Norian Drillable.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

33

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Australië
    • New South Wales
      • Liverpool, New South Wales, Australië, 2170
        • Liverpool Hospital
      • New Lambton, New South Wales, Australië, 2305
        • John Hunter Hospital
  • China
      • Hong Kong, China
        • Queen Mary Hospital
  • Nederland
      • Nieuwegein, Nederland, 3435
        • St. Antonius Ziekenhuis
      • Tilburg, Nederland, 5022
        • St. Elisabeth Ziekenhuis
  • Noorwegen
      • Tønsberg, Noorwegen, 3103
        • Sykehuset I Vestfold

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Primary care clinic

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: Case-Alleen
  • Tijdsperspectieven: Prospectief

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Behandeling
Apparaat: Norian Drillable Bone Void Filler
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:
  • Norian Drillable

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Duration of Time the Patient Was in the OR as a Measure of Effectiveness of the Treatment
Tijdsspanne: 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)
Estimate of Blood Loss in Cubic Centimeter as a Measure of Effectiveness of the Treatment
Tijdsspanne: 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)
Number of Patients With Adverse Events as a Measure of Safety and Tolerability of the Device
Tijdsspanne: 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
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
Ease of Use Score Measured With a Surgeon Questionnaire: Drill
Tijdsspanne: 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)
Ease of Use Score Measured With a Surgeon Questionnaire: K-wire
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Mixing
Tijdsspanne: 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)
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Handling
Tijdsspanne: 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)
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flow Properties
Tijdsspanne: 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)
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Flexibility With Surgical Procedure
Tijdsspanne: 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)
Ease of Use Score Measured With a Surgeon Questionnaire: Product Characteristics Overall Ease of Use
Tijdsspanne: 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)
Surgeons Overall Satisfaction With Norian Drillable
Tijdsspanne: Surgery
The overall satisfaction of the ease of use of Norian Drillable was rated by the surgeon.
Surgery

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pain and Function Assessed With the Lysholm Knee Scale
Tijdsspanne: 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.
6 weeks, 12 weeks, 26 weeks, 52 weeks, 78 weeks and 104 weeks (for Australian sites only)
Radiographic Parameters: Depression at Baseline
Tijdsspanne: Baseline
The anatomical grading parameter "depression" was assessed the following way: Anterior-Posterior (AP) and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Baseline
Radiographic Parameters: Depression at Surgery
Tijdsspanne: Surgery
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
Surgery
Radiographic Parameters: Depression at 6 Weeks
Tijdsspanne: 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
Radiographic Parameters: Depression at 12 Weeks
Tijdsspanne: 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
Radiographic Parameters: Depression at 26 Weeks
Tijdsspanne: 26 weeks
The anatomical grading parameter "depression" was assessed the following way: AP and lateral radiographs were taken for the fractured and healthy tibia plateau at Baseline, right after surgery and all follow-up timepoint. Additional oblique radiographs at 45° or other fracture imaging was optional. All post-operative radiographs were compared against the healthy tibia films post-surgery and all follow-up radiographs were compared with the post-operative radiographs to evaluate the quality and changes in reduction at each timepoint. CT scans were only mandatory at Baseline.
26 weeks
Radiographic Parameters:: Depression at 52 Weeks
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline
The extension ability of the knee was investigated by the investigator right after surgery (Baseline) and at each follow-up visit.
Baseline
Knee Function and Stability: Extension at 6 Weeks
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 78 weeks
Knee extension stability was evaluated by the investigator right after surgery (Baseline) and at each follow-up visit.
78 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Synthes GmbH

Medewerkers

Synthes Asia Pacific

Onderzoekers

  • Hoofdonderzoeker: Zsolt Balogh, MD, John Hunter Hospital, New Lambton, NSW, Australia
  • Hoofdonderzoeker: Ian Harris, MD, Liverpool Hospital, Liverpool, NSW, Australia

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2008

Primaire voltooiing (Werkelijk)

1 september 2013

Studie voltooiing (Werkelijk)

1 september 2013

Studieregistratiedata

Eerst ingediend

16 februari 2010

Eerst ingediend dat voldeed aan de QC-criteria

26 mei 2010

Eerst geplaatst (Schatting)

28 mei 2010

Updates van studierecords

Laatste update geplaatst (Schatting)

11 juni 2015

Laatste update ingediend die voldeed aan QC-criteria

26 mei 2015

Laatst geverifieerd

1 mei 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ND-AUS-01

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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