ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Knee osteoarthritis

Knee arthroplasty

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Surgery

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]

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]

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]

3 months post-operatively

Secondary outcome [1]

Timepoint [1]

2 days, 5 days and 12 months post-operatively

Secondary outcome [2]

Knee pain will be assessed using a 0-10 Likert scale (0=no pain, 10=extreme pain)

Timepoint [2]

2 & 5 days post-operatively

Secondary outcome [3]

Analgesic requirements will be determined from the patients hospital medication charts and the average morphine equivalent daily dose calculated (mg)

Timepoint [3]

First 5 days post-operatively

Secondary outcome [4]

Intra-operative blood loss (ml) will be estimated visually by the treating surgeon.

Timepoint [4]

Immediately following surgery

Secondary outcome [5]

Transfusions given (units) as recorded in the patient's hospital medical record

Timepoint [5]

At patient discharge from hospital

Secondary outcome [6]

Surgeon satisfaction with intra-operative visual field, assessed using a 1-10 Likert scale (1=completely unsatisfied, 10=completely satisfied)

Timepoint [6]

Immediately following surgery

Secondary outcome [7]

Operation and anaesthetic time as recorded in the patient's hospital medical record

Timepoint [7]

Immediately following surgery

Secondary outcome [8]

Tourniquet inflation time as recorded in the patient's hospital medical record

Timepoint [8]

Immediately following surgery

Secondary outcome [9]

Complications during inpatient stay as recorded in the patient's hospital medical record (deep vein thrombosis, pulmonary embolus)

Timepoint [9]

At patient discharge from hospital

Secondary outcome [10]

Oxford Knee Score (OKS) (Self-reported pain & physical function)

Timepoint [10]

3 & 12 months post-operatively

Secondary outcome [11]

Revision surgery as recorded in the patient's hospital medical record

Timepoint [11]

12 months postoperatively

Secondary outcome [12]

Cement mantle quality according to the Knee Society total knee arthroplasty roentgenographic evaluation and scoring system

Timepoint [12]

12 months post-operatively

Secondary outcome [13]

Patient satisfaction assessed with a 0-10 visual analogue scale

Timepoint [13]

3 & 12 months post-operatively

Secondary outcome [14]

Hospital length of stay according to the patient's hospital medical records

Timepoint [14]

At discharge from hospital

Secondary outcome [15]

WOMAC (Self-reported pain & physical function)

Timepoint [15]

3 & 12 months post-operatively

Secondary outcome [16]

EQ-5D-5L (quality of life)

Timepoint [16]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Barwon Health

Address [1]

Bellarine Street, Geelong, Victoria, Australia, 3220

Country [1]

Australia

Primary sponsor type

Hospital

Name

Barwon Health

Address

Bellarine Street, Geelong, Victoria, Australia, 3220

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Barwon Health Human Research Ethics Committee

Ethics committee address [1]

Bellarine Street, Geelong, Victoria, Australia, 3220

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

17/08/2012

Ethics approval number [1]

11/89

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Richard Page

Address

Barwon Centre for Orthopaedic Research and Education
St John of God Hospital
Myers St, Geelong, Victoria, Australia, 3220

Country

Australia

Phone

+61 3 5222 5777

Fax

[email protected]

Contact person for public queries

Name

Stephen Gill

Address

Barwon Centre for Orthopaedic Research and Education
St John of God Hospital
Myers St, Geelong, Victoria, Australia, 3220

Country

Australia

Phone

+61 3 52150902

Fax

[email protected]

Contact person for scientific queries

Name

Stephen Gill

Address

Barwon Centre for Orthopaedic Research and Education
St John of God Hospital
Myers St, Geelong, Victoria, Australia, 3220

Country

Australia

Phone

+61 3 52150902

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

We have yet to confirm our data sharing plans.

What supporting documents are/will be available?

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.

Trial Review

Documents added manually

Documents added automatically