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Trial registered on ANZCTR
Registration number
ACTRN12617000444381
Ethics application status
Approved
Date submitted
2/10/2014
Date registered
27/03/2017
Date last updated
9/07/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Examination of inflammatory markers associated with Total Knee Replacement surgery, and the association with coagulopathies (bleeding/clotting disorders)
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Scientific title
Examination of inflammatory markers associated with Total Knee Replacement surgery, and the association with coagulopathies using ROTEM (Rotational thromboelastometry)
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Secondary ID [1]
285363
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Nil
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Universal Trial Number (UTN)
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Trial acronym
ALM Pilot Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coagulation Disturbance
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Osteoarthritis
293092
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Condition category
Condition code
Inflammatory and Immune System
293365
293365
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0
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Other inflammatory or immune system disorders
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Blood
293366
293366
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0
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Clotting disorders
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Musculoskeletal
293367
293367
0
0
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Osteoarthritis
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Patients will undergo a series of blood tests during their routine Total Knee Replacement surgery (TKR) and post-operative whilst in the ward during recovery. There are 6 time points at which blood will be taken and analysed for inflammatory and coagulopathic response to TKR surgery. Four (4) of the blood tests will be conducted under anaesthetic during surgery and soon after surgery in the recovery room, Two (2) samples will be conducted on the ward, post-operatively. Blood will be drawn by the anaesthetist during surgery and by the patient's doctor during their ward stay.
The duration of observation for each study participant is a period of 6 months following TKR.
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Intervention code [1]
290358
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Not applicable
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Comparator / control treatment
There is no control group. All patients will undergo the same procedure, and undergo the same cohort of blood tests.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Examine inflammatory markers (but not limited to) IL-1b, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, CRP, TNF-a, GM-CSF) in preoperative and postoperative blood samples and define the association with coagulopathies using ROTEM tests (EXTEM, FIBTEM and INTEM).
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Assessment method [1]
293285
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Timepoint [1]
293285
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1. Pre-op before Spinal. Rotem and Inflammatory
2. Skin incision - Rotem and Inflammatory
3. Bone cuts - Rotem and Inflammatory
4. Recovery - Rotem and Inflammatory
5. Day 1 recovery - Inflammatory including CRP
6. Day 3 recovery - Inflammatory including CRP
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Secondary outcome [1]
310715
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The Likert Questionnaire will be used to measure patient's sleep patterns
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Assessment method [1]
310715
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Timepoint [1]
310715
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14 day diary, commencing from day 1 of surgery to the first post op clinic
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Secondary outcome [2]
310716
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The Oxford 12-item Knee Questionnaire will be used to assess patient-reported knee function and pain following TKR
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Assessment method [2]
310716
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Timepoint [2]
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The Oxford 12-item Knee Questionnaire will be completed preoperatively and at 6 weeks and 6 months post-TKR surgery
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Secondary outcome [3]
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Patients perception of surgery efficacy will be assessed using the KOOS Patient Response Outcomes Measures
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Assessment method [3]
322304
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Timepoint [3]
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The KOOS will be completed preoperatively and at 6 weeks and 6 months post-TKR surgery
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Secondary outcome [4]
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The EQ-5D will be used to assess patient-reported health outcomespost TKR surgery
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Assessment method [4]
332576
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Timepoint [4]
332576
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The EQ-5D will be completed preoperatively and at 6 weeks and 6 months post TKR surgery
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Eligibility
Key inclusion criteria
Patients scheduled to undergo primary unilateral total knee replacement (TKR) will be eligible for inclusion in this study, Additional inclusion criteria that must be met are:
Age 40 - 75
Osteoarthritis of the knee; radiologically confirmed
Medically fit to undergo TKR
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Minimum age
40
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients taking anti-coagulant medication or have an existing medical condition which may increase their risk for coagulopathy during surgery.
Patients with known chronic inflammatory diseases, recent antibiotic treatment or inter-current infections before surgery, vascular disorders or autoimmune disorders will be excluded as cytokine response can be abnormal in response to these conditions.
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
There is no power calculation to support the sample size for this observational study. This is a pilot study and is designed to identify specific key inflammatory markers to inform samples sizes for larger studies in the future.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
5/03/2015
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Date of last participant enrolment
Anticipated
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Actual
17/02/2017
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Date of last data collection
Anticipated
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Actual
17/08/2017
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Sample size
Target
20
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Accrual to date
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Final
22
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment postcode(s) [1]
8760
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4812 - Pimlico
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Funding & Sponsors
Funding source category [1]
290038
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Other
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Name [1]
290038
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Orthopaedic Research Institute of Queensland (ORIQL)
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Address [1]
290038
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7 Turner Street
Pimlico, Townsville QLD 4812
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Country [1]
290038
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Australia
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Primary sponsor type
Other
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Name
Orthopaedic Research Institute of Queensland (ORIQL)
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Address
7 Turner Street
Pimlico, Townsville QLD 4812
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Country
Australia
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Secondary sponsor category [1]
292032
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None
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Name [1]
292032
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Address [1]
292032
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Country [1]
292032
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
291749
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Mater Health Services North Queensland Human Research Ethics Committee
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Ethics committee address [1]
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21-37 Fulham Rd Pimlico, QLD 4812
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Ethics committee country [1]
291749
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Australia
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Date submitted for ethics approval [1]
291749
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12/08/2014
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Approval date [1]
291749
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12/09/2014
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Ethics approval number [1]
291749
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HREC
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Summary
Brief summary
The primary aim of this project is to examine specific inflammatory markers and define the association with coagulopathies in patients undergoing elective total knee arthroplasty (TKA). A total of 20 patients will be observed in the trial; these patients are all undergoing Primary TKA for treatment of osteoarthritis (OA). There are multiple traumatic events that occur over the duration of TKA surgery, all which illicit some form of inflammatory and immune response; it is this response that we are interested in examining. Disruption to the skin, bone and synovial membrane all trigger an inflammatory cytokine cascade. The concentrations in peripheral blood of selected cytokines have been reported to undergo more rapid increases and quicker return to normal values after surgery than either CRP or ESR suggesting they may be better markers for risk of early infection following TKR. There has been limited research to determine whether there is an association between particular inflammatory cytokine markers, coagulopathies and clinical outcomes post-surgery. We aim to examine the changes in concentration of key inflammatory cytokine markers in peripheral blood of elective TKA patients during and after surgery and to define the association with coagulopathies. Patients undergoing unilateral TKA for OA will have blood samples taken at six time-points peri-operative and on the ward at day one and three post-surgery The blood samples will be used for analysis of key inflammatory markers and coagulopathy parameters. Patient-reported health outcomes relating to pain, analgesia, sleep and joint function will be completed pre and post-surgery. Patient rehabilitation post-surgery will be consistent with current standard protocols with the exception of NSAID administration, unless otherwise advised. The use of tranexamic acid during TKA to treat or prevent excessive blood loss during surgery will be recorded. Data collected will be analysed to identify significant changes in both coagulation and inflammatory markers in response to trauma during surgery and in recovery, Correlations between biological markers and patient health outcomes will be explored.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Peter McEwen
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Address
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Peter McEwen Orthopaedic Surgeon
Suite 3, Level 2, Mater Medical Centre 21-29 Fulham Rd
Pimlico, Qld 4812
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Country
51518
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Australia
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Phone
51518
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61747794788
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Fax
51518
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Email
51518
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[email protected]
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Contact person for public queries
Name
51519
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Andrea Grant
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Address
51519
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ORIQL - Research Coordinator
7 Turner Street
Pimlico, QLD, 4812
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Country
51519
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Australia
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Phone
51519
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617477753564
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Fax
51519
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Email
51519
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[email protected]
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Contact person for scientific queries
Name
51520
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Andrea Grant
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Address
51520
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ORIQL - Research Coordinator
7 Turner Street
Pimlico, QLD, 4812
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Country
51520
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Australia
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Phone
51520
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617477753564
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Fax
51520
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Email
51520
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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