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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
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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
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Secondary ID [1]
294311
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis
306924
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Knee arthroplasty
306925
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Condition category
Condition code
Musculoskeletal
306023
306023
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0
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Osteoarthritis
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Surgery
306118
306118
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0
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Surgical techniques
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
300542
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Treatment: Surgery
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
305057
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Timepoint [1]
305057
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3 months post-operatively
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Secondary outcome [1]
344004
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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.
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Assessment method [1]
344004
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Timepoint [1]
344004
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2 days, 5 days and 12 months post-operatively
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Secondary outcome [2]
344007
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Knee pain will be assessed using a 0-10 Likert scale (0=no pain, 10=extreme pain)
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Assessment method [2]
344007
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Timepoint [2]
344007
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2 & 5 days post-operatively
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Secondary outcome [3]
344008
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Analgesic requirements will be determined from the patients hospital medication charts and the average morphine equivalent daily dose calculated (mg)
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Assessment method [3]
344008
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Timepoint [3]
344008
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First 5 days post-operatively
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Secondary outcome [4]
344009
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Intra-operative blood loss (ml) will be estimated visually by the treating surgeon.
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Assessment method [4]
344009
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Timepoint [4]
344009
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Immediately following surgery
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Secondary outcome [5]
344010
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Transfusions given (units) as recorded in the patient's hospital medical record
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Assessment method [5]
344010
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Timepoint [5]
344010
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At patient discharge from hospital
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Secondary outcome [6]
344012
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Surgeon satisfaction with intra-operative visual field, assessed using a 1-10 Likert scale (1=completely unsatisfied, 10=completely satisfied)
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Assessment method [6]
344012
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Timepoint [6]
344012
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Immediately following surgery
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Secondary outcome [7]
344013
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Operation and anaesthetic time as recorded in the patient's hospital medical record
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Assessment method [7]
344013
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Timepoint [7]
344013
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Immediately following surgery
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Secondary outcome [8]
344014
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Tourniquet inflation time as recorded in the patient's hospital medical record
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Assessment method [8]
344014
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Timepoint [8]
344014
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Immediately following surgery
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Secondary outcome [9]
344015
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Complications during inpatient stay as recorded in the patient's hospital medical record (deep vein thrombosis, pulmonary embolus)
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Assessment method [9]
344015
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Timepoint [9]
344015
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At patient discharge from hospital
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Secondary outcome [10]
344016
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Oxford Knee Score (OKS) (Self-reported pain & physical function)
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Assessment method [10]
344016
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Timepoint [10]
344016
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3 & 12 months post-operatively
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Secondary outcome [11]
344017
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Revision surgery as recorded in the patient's hospital medical record
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Assessment method [11]
344017
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Timepoint [11]
344017
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12 months postoperatively
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Secondary outcome [12]
344018
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Cement mantle quality according to the Knee Society total knee arthroplasty roentgenographic evaluation and scoring system
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Assessment method [12]
344018
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Timepoint [12]
344018
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12 months post-operatively
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Secondary outcome [13]
344019
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Patient satisfaction assessed with a 0-10 visual analogue scale
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Assessment method [13]
344019
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Timepoint [13]
344019
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3 & 12 months post-operatively
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Secondary outcome [14]
344020
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Hospital length of stay according to the patient's hospital medical records
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Assessment method [14]
344020
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Timepoint [14]
344020
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At discharge from hospital
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Secondary outcome [15]
344597
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WOMAC (Self-reported pain & physical function)
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Assessment method [15]
344597
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Timepoint [15]
344597
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3 & 12 months post-operatively
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Secondary outcome [16]
344601
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EQ-5D-5L (quality of life)
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Assessment method [16]
344601
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Timepoint [16]
344601
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3 & 12 months post-operatively
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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
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Minimum age
18
Years
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Maximum age
No limit
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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
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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
1/10/2014
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Date of last participant enrolment
Anticipated
31/10/2019
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Actual
16/01/2020
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Date of last data collection
Anticipated
16/01/2021
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Actual
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Sample size
Target
90
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Accrual to date
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Final
90
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
298884
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Hospital
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Name [1]
298884
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Barwon Health
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Address [1]
298884
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Bellarine Street, Geelong, Victoria, Australia, 3220
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Country [1]
298884
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Australia
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Primary sponsor type
Hospital
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Name
Barwon Health
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Address
Bellarine Street, Geelong, Victoria, Australia, 3220
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Country
Australia
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Secondary sponsor category [1]
298172
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None
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Name [1]
298172
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Address [1]
298172
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Country [1]
298172
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299826
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Barwon Health Human Research Ethics Committee
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Ethics committee address [1]
299826
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Bellarine Street, Geelong, Victoria, Australia, 3220
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Ethics committee country [1]
299826
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Australia
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Date submitted for ethics approval [1]
299826
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Approval date [1]
299826
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17/08/2012
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Ethics approval number [1]
299826
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11/89
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Summary
Brief summary
The objective of the study is to determine whether tourniquet use during total knee replacement results in superior intra-operative and post-operative outcomes when compared to not using a tourniquet. All participants will be undergoing total knee replacement for advanced osteoarthritis. Participants will be followed up for one year following surgery. Outcomes include knee extension strength, pain and analgesia requirements, self-reported physical function and quality of life, blood loss and replacement, surgeon satisfaction with the intra-operative visual field, operation and anaesthetic time, tourniquet inflation time, complications including revision surgery, cement mantle quality, patient satisfaction, and hospital length of stay.
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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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Prof Richard Page
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Address
81690
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Barwon Centre for Orthopaedic Research and Education
St John of God Hospital
Myers St, Geelong, Victoria, Australia, 3220
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Country
81690
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Australia
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Phone
81690
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+61 3 5222 5777
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Fax
81690
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Email
81690
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richard.page@deakin.edu.au
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Contact person for public queries
Name
81691
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Stephen Gill
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Address
81691
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Barwon Centre for Orthopaedic Research and Education
St John of God Hospital
Myers St, Geelong, Victoria, Australia, 3220
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Country
81691
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Australia
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Phone
81691
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+61 3 52150902
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Fax
81691
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Email
81691
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stephen.gill2@deakin.edu.au
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Contact person for scientific queries
Name
81692
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Stephen Gill
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Address
81692
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Barwon Centre for Orthopaedic Research and Education
St John of God Hospital
Myers St, Geelong, Victoria, Australia, 3220
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Country
81692
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Australia
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Phone
81692
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+61 3 52150902
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Fax
81692
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Email
81692
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stephen.gill2@deakin.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
We have yet to confirm our data sharing plans.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
4042
Study protocol
Page 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/s12891-018-2352-8
https://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
Source
Title
Year of Publication
DOI
Embase
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.
2018
https://dx.doi.org/10.1186/s12891-018-2352-8
N.B. These documents automatically identified may not have been verified by the study sponsor.
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