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Trial registered on ANZCTR


Registration number
ACTRN12618000425291
Ethics application status
Approved
Date submitted
6/03/2018
Date registered
23/03/2018
Date last updated
14/01/2021
Date data sharing statement initially provided
26/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the effects of tourniquet use in total knee arthroplasty
Scientific title
A single-centre, parallel-arm, double-blind randomised trial evaluating the effects of tourniquet use in total knee arthroplasty on intra-operative and post-operative outcomes
Secondary ID [1] 294311 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 306924 0
Knee arthroplasty 306925 0
Condition category
Condition code
Musculoskeletal 306023 306023 0 0
Osteoarthritis
Surgery 306118 306118 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants are undergoing total knee replacement.

Orthopaedic surgeons will complete each knee replacement, with training registrars operating under direct supervision. Each operation will last approximately 2 hours. The tourniquet will be used for the duration of the procedure and deflated immediately prior to wound closure.

Participants in the tourniquet group will have a tourniquet applied during surgery. After exsanguination of the operated limb with a rubber tube exsanguinator, the tourniquet will be inflated to 100mmHg above systolic blood pressure or 250mmHg, whichever is higher.

Adherence to the intervention protocol will be monitored by the principal investigator (orthopaedic surgeon) and research coordinator.
Intervention code [1] 300542 0
Treatment: Surgery
Comparator / control treatment
All participants are undergoing total knee replacement.

Orthopaedic surgeons will complete each knee replacement, with training registrars operating under direct supervision. Each operation will last approximately 2 hours.

Participants in the no-tourniquet group will not have a tourniquet applied during total knee replacement surgery.

Adherence to the intervention protocol will be monitored by the principal investigator (orthopaedic surgeon) and research coordinator.
Control group
Active

Outcomes
Primary outcome [1] 305057 0
Isometric quadriceps strength will be measured in Newtons and assessed by a trained research assistant using a fixed-base electromechanical dynamometer (IsoForceControl EVO2 dynamometer) with the knee stabilised in 60 degrees of flexion. Patient will be seated in a customised chair with a frame to fix the dynamometer in position. Following 1-2 practices, participants will extend their knee as forcefully as they can for 10 seconds. The maximum force from three consecutive attempts will be recorded.
Timepoint [1] 305057 0
3 months post-operatively
Secondary outcome [1] 344004 0
Isometric quadriceps strength will be measured in Newtons and assessed by a trained research assistant using a fixed-base electromechanical dynamometer (IsoForceControl EVO2 dynamometer) with the knee stabilised in 60 degrees of flexion. Patient will be seated in a customised chair with a frame to fix the dynamometer in position. Following 1-2 practices, participants will extend their knee as forcefully as they can for 10 seconds. The maximum force from three consecutive attempts will be recorded.
Timepoint [1] 344004 0
2 days, 5 days and 12 months post-operatively
Secondary outcome [2] 344007 0
Knee pain will be assessed using a 0-10 Likert scale (0=no pain, 10=extreme pain)
Timepoint [2] 344007 0
2 & 5 days post-operatively
Secondary outcome [3] 344008 0
Analgesic requirements will be determined from the patients hospital medication charts and the average morphine equivalent daily dose calculated (mg)
Timepoint [3] 344008 0
First 5 days post-operatively
Secondary outcome [4] 344009 0
Intra-operative blood loss (ml) will be estimated visually by the treating surgeon.
Timepoint [4] 344009 0
Immediately following surgery
Secondary outcome [5] 344010 0
Transfusions given (units) as recorded in the patient's hospital medical record
Timepoint [5] 344010 0
At patient discharge from hospital
Secondary outcome [6] 344012 0
Surgeon satisfaction with intra-operative visual field, assessed using a 1-10 Likert scale (1=completely unsatisfied, 10=completely satisfied)
Timepoint [6] 344012 0
Immediately following surgery
Secondary outcome [7] 344013 0
Operation and anaesthetic time as recorded in the patient's hospital medical record
Timepoint [7] 344013 0
Immediately following surgery
Secondary outcome [8] 344014 0
Tourniquet inflation time as recorded in the patient's hospital medical record
Timepoint [8] 344014 0
Immediately following surgery
Secondary outcome [9] 344015 0
Complications during inpatient stay as recorded in the patient's hospital medical record (deep vein thrombosis, pulmonary embolus)
Timepoint [9] 344015 0
At patient discharge from hospital
Secondary outcome [10] 344016 0
Oxford Knee Score (OKS) (Self-reported pain & physical function)
Timepoint [10] 344016 0
3 & 12 months post-operatively
Secondary outcome [11] 344017 0
Revision surgery as recorded in the patient's hospital medical record
Timepoint [11] 344017 0
12 months postoperatively
Secondary outcome [12] 344018 0
Cement mantle quality according to the Knee Society total knee arthroplasty roentgenographic evaluation and scoring system
Timepoint [12] 344018 0
12 months post-operatively
Secondary outcome [13] 344019 0
Patient satisfaction assessed with a 0-10 visual analogue scale
Timepoint [13] 344019 0
3 & 12 months post-operatively
Secondary outcome [14] 344020 0
Hospital length of stay according to the patient's hospital medical records
Timepoint [14] 344020 0
At discharge from hospital
Secondary outcome [15] 344597 0
WOMAC (Self-reported pain & physical function)
Timepoint [15] 344597 0
3 & 12 months post-operatively
Secondary outcome [16] 344601 0
EQ-5D-5L (quality of life)
Timepoint [16] 344601 0
3 & 12 months post-operatively

Eligibility
Key inclusion criteria
1. undergoing primary total knee replacement for primary osteoarthritis
2. > 18 years of age
3. Willing, able and mentally competent to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Undergoing bilateral total knee replacement
2. Neurological deficit affecting operated knee
3. Rheumatoid arthritis
4. Pre-operative knee flexion <60 (degree of flexion required for strength testing)
5. Varus/valgus deformity > 15
6. Opioid tolerant (current use of oxycontin, opioid patches, or tramadol; >4 tabs panadeine forte per day)
7. Sulphonamide allergy (to allow parecoxib/celecoxib use)
8. Intolerant/allergic to oxycodone
9. Poorly controlled diabetes (HbA1C >8) (impacts on choice of dexamethasone as antiemetic)
10. Cognitively impaired (mini-mental state examination of <25/30 [18])
11. eGFR < 60 mL/min/1.73m2 (to allow parecoxib/celecoxib use)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed until immediately prior to anaesthetic induction, at which time the surgeon will access the allocation code for that participant via an opaque sealed envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be computer generated using a 1:1 allocation ratio in blocks of 10.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
1/10/2014
Date of last participant enrolment
Anticipated
31/10/2019
Actual
16/01/2020
Date of last data collection
Anticipated
16/01/2021
Actual
Sample size
Target
90
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 298884 0
Hospital
Name [1] 298884 0
Barwon Health
Country [1] 298884 0
Australia
Primary sponsor type
Hospital
Name
Barwon Health
Address
Bellarine Street, Geelong, Victoria, Australia, 3220
Country
Australia
Secondary sponsor category [1] 298172 0
None
Name [1] 298172 0
Address [1] 298172 0
Country [1] 298172 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299826 0
Barwon Health Human Research Ethics Committee
Ethics committee address [1] 299826 0
Ethics committee country [1] 299826 0
Australia
Date submitted for ethics approval [1] 299826 0
Approval date [1] 299826 0
17/08/2012
Ethics approval number [1] 299826 0
11/89

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81690 0
Prof Richard Page
Address 81690 0
Barwon Centre for Orthopaedic Research and Education
St John of God Hospital
Myers St, Geelong, Victoria, Australia, 3220
Country 81690 0
Australia
Phone 81690 0
+61 3 5222 5777
Fax 81690 0
Email 81690 0
richard.page@deakin.edu.au
Contact person for public queries
Name 81691 0
Stephen Gill
Address 81691 0
Barwon Centre for Orthopaedic Research and Education
St John of God Hospital
Myers St, Geelong, Victoria, Australia, 3220
Country 81691 0
Australia
Phone 81691 0
+61 3 52150902
Fax 81691 0
Email 81691 0
stephen.gill2@deakin.edu.au
Contact person for scientific queries
Name 81692 0
Stephen Gill
Address 81692 0
Barwon Centre for Orthopaedic Research and Education
St John of God Hospital
Myers St, Geelong, Victoria, Australia, 3220
Country 81692 0
Australia
Phone 81692 0
+61 3 52150902
Fax 81692 0
Email 81692 0
stephen.gill2@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We have yet to confirm our data sharing plans.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4042Study protocolPage RS, Williams S, Selvaratnam A, Waring S, Conroy M, Thomson A, Beattie S, Ganeshalingam R, Gill SD. Protocol for a single-centre, parallel-arm, double-blind randomised trial evaluating the effects of tourniquet use in total knee arthroplasty on intra-operative and post-operative outcomes. BMC Musculoskelet Disord 2018;19(1):435. doi: 10.1186/s12891-018-2352-8https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-018-2352-8 



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for a single-centre, parallel-arm, double-blind randomised trial evaluating the effects of tourniquet use in total knee arthroplasty on intra-operative and post-operative outcomes.2018https://dx.doi.org/10.1186/s12891-018-2352-8
N.B. These documents automatically identified may not have been verified by the study sponsor.