Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001600235
Ethics application status
Approved
Date submitted
22/09/2018
Date registered
26/09/2018
Date last updated
26/09/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does the medication 'tranexamic acid' decrease pain and improve function in the short term after arthroscopic meniscectomy?
Scientific title
Does the medication 'tranexamic acid' decrease pain and improve function in the short term after arthroscopic meniscectomy?
Secondary ID [1] 296130 0
None
Universal Trial Number (UTN)
U1111-1220-6679
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthroscopic meniscectomy for meniscal tear 309713 0
Condition category
Condition code
Musculoskeletal 308518 308518 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administration of tranexamic acid (one dose 1g in 10ml of 0.9% saline solution) or placebo (10ml 0.9% saline solution) intraoperatively. This is administered intravenously by the anaesthetist immediately post-induction.
Intervention code [1] 312459 0
Treatment: Drugs
Comparator / control treatment
Placebo (10ml 0.9% saline solution) administered intraoperatively
Control group
Placebo

Outcomes
Primary outcome [1] 307489 0
Pain (scale 0-10)
Timepoint [1] 307489 0
3 days, 14 days, 30 days
Primary outcome [2] 307490 0
Swelling (measurement of suprapatellar and mid-calf circumferences in cm, using measuring tape)
Timepoint [2] 307490 0
3 days, 14 days, 30 days
Primary outcome [3] 307491 0
Range of movement of knee flexion and extension in degrees, assessed using goniometer
Timepoint [3] 307491 0
3 days, 14 days, 30 days
Secondary outcome [1] 352063 0
Functional status as assessed by Lysholm knee score and Tegener activity score
Timepoint [1] 352063 0
3 days, 14 days, 30 days

Eligibility
Key inclusion criteria
Patients undergoing elective arthroscopic meniscectomy for meniscal tear(s)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous reconstructive surgery on the same knee
Known clotting disorders
Known renal impairment
Known allergy to tranexamic acid

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer generated sequence of groupings - 'a' or 'b'
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
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pilot study with 40 patients randomly assigned to two groups. Plan to evaluate data at the three time points stated (paired t-testing of mean numerical scores and measurements) to assess for differences between the groups. Following pilot study and analysis, decision regarding further expansion of study groups/continuation of study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/04/2018
Date of last participant enrolment
Anticipated
28/09/2018
Actual
Date of last data collection
Anticipated
29/10/2018
Actual
Sample size
Target
40
Accrual to date
36
Final
Recruitment outside Australia
Country [1] 20854 0
New Zealand
State/province [1] 20854 0
Canterbury

Funding & Sponsors
Funding source category [1] 300715 0
Government body
Name [1] 300715 0
Canterbury District Health Board
Country [1] 300715 0
New Zealand
Primary sponsor type
Individual
Name
Prof Gary Hooper
Address
Dept of Orthopaedic Surgery and Musculoskeletal Medicine
University of Otago Christchurch
PO Box 4345
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 300252 0
Individual
Name [1] 300252 0
Mary Nugent
Address [1] 300252 0
Dept of Orthopaedic Surgery
Christchurch Hospital
2 Riccarton Avenue
Christchurch 8011
Country [1] 300252 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301499 0
Southern Health and Disability Ethics Committees
Ethics committee address [1] 301499 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 301499 0
New Zealand
Date submitted for ethics approval [1] 301499 0
14/12/2017
Approval date [1] 301499 0
27/03/2018
Ethics approval number [1] 301499 0
18/STH/10

Summary
Brief summary
The aim of this pilot study is assess the efficacy of tranexamic acid in reducing post-operative pain, swelling and range of motion in patients undergoing arthroscopic meniscectomies. It is a blinded study in which participants are randomised to receive one intraoperative dose of either intravenous tranexamic acid or placebo (saline). Data collected is as follows: pain (0-10 scale), Lysholm knee score and Tegener activity score (to assess function), range of motion (measured by goniometer), suprapatellar and mid-calf circumferences (to assess swelling). Each of these data sets is collected pre-operatively (on the morning of surgery) and at three time points post-operatively (3, 14 and 30 days).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87202 0
Prof Gary Hooper
Address 87202 0
Dept of Orthopaedic Surgery and Musculoskeletal Medicine
University of Otago Christchurch
PO Box4345
Christchurch 8014
Country 87202 0
New Zealand
Phone 87202 0
+64 33641086
Fax 87202 0
Email 87202 0
[email protected]
Contact person for public queries
Name 87203 0
Dr Mary Nugent
Address 87203 0
Dept of Trauma & Orthopaedics
Christchurch Hospital
2 Riccarton Avenue
Christchurch 8011
Country 87203 0
New Zealand
Phone 87203 0
+64 33640640
Fax 87203 0
Email 87203 0
[email protected]
Contact person for scientific queries
Name 87204 0
Dr Mary Nugent
Address 87204 0
Dept of Trauma & Orthopaedics
Christchurch Hospital
2 Riccarton Avenue
Christchurch 8011
Country 87204 0
New Zealand
Phone 87204 0
+64 33640640
Fax 87204 0
Email 87204 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23691Study protocol   
23692Informed consent form   
23693Clinical study report   
23694Ethical approval   

Results publications and other study-related documents

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

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3853Basic resultsNo 376036-(Uploaded-02-09-2019-10-34-44)-Basic results summary.pdf
4101Plain language summaryNo Due to be published in Orthopaedic Journal of Spor... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDoes intravenous or intraarticular tranexamic acid (TXA) reduce joint bleeding following arthroscopic anterior cruciate ligament (ACL) reconstruction and arthroscopic meniscectomy? Can intraarticular use be harmful to chondrocytes?.2020https://dx.doi.org/10.22038/abjs.2020.50710.2513
EmbaseTranexamic acid is effective in decreasing postoperative intraarticular bleeding in arthroscopic knee surgery.2020https://dx.doi.org/10.1097/MBC.0000000000000895
EmbaseDoes Tranexamic Acid Reduce Knee Swelling and Improve Early Function Following Arthroscopic Meniscectomy? A Double-Blind Randomized Controlled Trial.2019https://dx.doi.org/10.1177/2325967119866122
N.B. These documents automatically identified may not have been verified by the study sponsor.