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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)
Scientific title
Examination of inflammatory markers associated with Total Knee Replacement surgery, and the association with coagulopathies using ROTEM (Rotational thromboelastometry)
Secondary ID [1] 285363 0
Nil
Universal Trial Number (UTN)
Trial acronym
ALM Pilot Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coagulation Disturbance
 293090 0
Osteoarthritis 293092 0
Condition category
Condition code
Inflammatory and Immune System 293365 293365 0 0
Other inflammatory or immune system disorders
Blood 293366 293366 0 0
Clotting disorders
Musculoskeletal 293367 293367 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 290358 0
Not applicable
Comparator / control treatment
There is no control group. All patients will undergo the same procedure, and undergo the same cohort of blood tests.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293285 0
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).
Timepoint [1] 293285 0
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
Secondary outcome [1] 310715 0
The Likert Questionnaire will be used to measure patient's sleep patterns
Timepoint [1] 310715 0
14 day diary, commencing from day 1 of surgery to the first post op clinic
Secondary outcome [2] 310716 0
The Oxford 12-item Knee Questionnaire will be used to assess patient-reported knee function and pain following TKR
Timepoint [2] 310716 0
The Oxford 12-item Knee Questionnaire will be completed preoperatively and at 6 weeks and 6 months post-TKR surgery
Secondary outcome [3] 322304 0
Patients perception of surgery efficacy will be assessed using the KOOS Patient Response Outcomes Measures
Timepoint [3] 322304 0
The KOOS will be completed preoperatively and at 6 weeks and 6 months post-TKR surgery
Secondary outcome [4] 332576 0
The EQ-5D will be used to assess patient-reported health outcomespost TKR surgery
Timepoint [4] 332576 0
The EQ-5D will be completed preoperatively and at 6 weeks and 6 months post TKR surgery

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
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/03/2015
Date of last participant enrolment
Anticipated
Actual
17/02/2017
Date of last data collection
Anticipated
Actual
17/08/2017
Sample size
Target
20
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 8760 0
4812 - Pimlico

Funding & Sponsors
Funding source category [1] 290038 0
Other
Name [1] 290038 0
Orthopaedic Research Institute of Queensland (ORIQL)
Country [1] 290038 0
Australia
Primary sponsor type
Other
Name
Orthopaedic Research Institute of Queensland (ORIQL)
Address
7 Turner Street
Pimlico, Townsville QLD 4812
Country
Australia
Secondary sponsor category [1] 292032 0
None
Name [1] 292032 0
Address [1] 292032 0
Country [1] 292032 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291749 0
Mater Health Services North Queensland Human Research Ethics Committee
Ethics committee address [1] 291749 0
21-37 Fulham Rd
Pimlico, QLD 4812
Ethics committee country [1] 291749 0
Australia
Date submitted for ethics approval [1] 291749 0
12/08/2014
Approval date [1] 291749 0
12/09/2014
Ethics approval number [1] 291749 0
HREC

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51518 0
Dr Peter McEwen
Address 51518 0
Peter McEwen Orthopaedic Surgeon
Suite 3, Level 2, Mater Medical Centre 21-29 Fulham Rd
Pimlico, Qld 4812
Country 51518 0
Australia
Phone 51518 0
61747794788
Fax 51518 0
Email 51518 0
peter@kneesurgeon.com.au
Contact person for public queries
Name 51519 0
Andrea Grant
Address 51519 0
ORIQL - Research Coordinator
7 Turner Street
Pimlico, QLD, 4812
Country 51519 0
Australia
Phone 51519 0
617477753564
Fax 51519 0
Email 51519 0
research_coordinator@oriql.com.au
Contact person for scientific queries
Name 51520 0
Andrea Grant
Address 51520 0
ORIQL - Research Coordinator
7 Turner Street
Pimlico, QLD, 4812
Country 51520 0
Australia
Phone 51520 0
617477753564
Fax 51520 0
Email 51520 0
research_coordinator@oriql.com

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

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