ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

ALM Pilot Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Coagulation Disturbance

Osteoarthritis

Condition category

Condition code

Inflammatory and Immune System

Other inflammatory or immune system disorders

Blood

Clotting disorders

Musculoskeletal

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]

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]

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]

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]

The Likert Questionnaire will be used to measure patient's sleep patterns

Timepoint [1]

14 day diary, commencing from day 1 of surgery to the first post op clinic

Secondary outcome [2]

The Oxford 12-item Knee Questionnaire will be used to assess patient-reported knee function and pain following TKR

Timepoint [2]

The Oxford 12-item Knee Questionnaire will be completed preoperatively and at 6 weeks and 6 months post-TKR surgery

Secondary outcome [3]

Patients perception of surgery efficacy will be assessed using the KOOS Patient Response Outcomes Measures

Timepoint [3]

The KOOS will be completed preoperatively and at 6 weeks and 6 months post-TKR surgery

Secondary outcome [4]

The EQ-5D will be used to assess patient-reported health outcomespost TKR surgery

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4812 - Pimlico

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Orthopaedic Research Institute of Queensland (ORIQL)

Address [1]

7 Turner Street
Pimlico, Townsville QLD 4812

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mater Health Services North Queensland Human Research Ethics Committee

Ethics committee address [1]

21-37 Fulham Rd
Pimlico, QLD 4812

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/08/2014

Approval date [1]

12/09/2014

Ethics approval number [1]

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

Dr Peter McEwen

Address

Peter McEwen Orthopaedic Surgeon
Suite 3, Level 2, Mater Medical Centre 21-29 Fulham Rd
Pimlico, Qld 4812

Country

Australia

Phone

61747794788

Fax

peter@kneesurgeon.com.au

Contact person for public queries

Name

Andrea Grant

Address

ORIQL - Research Coordinator
7 Turner Street
Pimlico, QLD, 4812

Country

Australia

Phone

617477753564

Fax

research_coordinator@oriql.com.au

Contact person for scientific queries

Name

Andrea Grant

Address

ORIQL - Research Coordinator
7 Turner Street
Pimlico, QLD, 4812

Country

Australia

Phone

617477753564

Fax

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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Documents added automatically

No additional documents have been identified.

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