Trial Review

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
ACTRN12618000734268
Ethics application status
Approved
Date submitted
12/12/2017
Date registered
2/05/2018
Date last updated
2/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Comparative Outcome Study Using Tranexamic Acid in Arthroscopic Medial Meniscectomy
Scientific title
A Comparative Outcome Study Using Tranexamic Acid for pain in patients undergoing Arthroscopic Medial Meniscectomy
Secondary ID [1] 293589 0
None
Universal Trial Number (UTN)
U1111-1206-5126
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemarthrosis 305837 0
Arthroscopic meniscectomy 305838 0
Condition category
Condition code
Musculoskeletal 305049 305049 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The dose of 1 gram if tranexamic acid intravenously administered by the anaesthetist under supervision of the lead researcher will be given at induction prior to tourniquet inflation in 100 ml of normal saline as a single bolus.
Intervention code [1] 299843 0
Treatment: Drugs
Comparator / control treatment
In the placebo group they will be given 100 ml of normal saline intravenously at induction via an identically labeled syringe
Control group
Placebo

Outcomes
Primary outcome [1] 304208 0
Visual analogue scale pain
Timepoint [1] 304208 0
Day 14 post operative
Secondary outcome [1] 341257 0
100mm visual analogue scale pain
Timepoint [1] 341257 0
Day 3 and 30 post operatively
Secondary outcome [2] 341258 0
Haemarthrosis will be graded as per Coupens and Yates
Timepoint [2] 341258 0
Days 3, 14 and 30 post operatively
Secondary outcome [3] 345076 0
Swelling measured as diameter at the superior patellar border (suprapatellar girth) and the maximum circumference of the calf (calf girth)
Timepoint [3] 345076 0
Days 3, 14 and 30 postoperatively
Secondary outcome [4] 345077 0
Lysholm and Tegner knee functional scores
Timepoint [4] 345077 0
Days 3, 14 and 30 postoperatively

Eligibility
Key inclusion criteria
Patients at the offices of the primary surgeon with the intention of undergoing an arthroscopic meniscectomy will be screened for enrolment at the preoperative clinic using a screening form

Indication for meniscectomy includes but is not limited to a patient presenting with painful knee with locking, clicking or instability with examination findings of McMurray's test positive, tender joint line having an isolated meniscal tear on MRI and having trailed period of nonoperative management with no other cause for knee pain identified.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Our exclusion criteria will be younger than 18 years old, a history of bleeding or clotting disorder, pregnancy, preoperative anticoagulation therapy, renal disorder, allergy to local anesthetics or tranexamic acid, large preoperative swelling (grade 3 or 4 effusion), concurrent ligament injury, prior anterior cruciate ligament reconstruction, microfracture or a revision surgery.

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)
The clinical secretary will control the randomization schedule. Once the patient is consented, the patient will be given a study number and study category of “A” or “B”.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A master randomization schedule will be created at the initiation of the study based on atmospheric noise randomization generator found at Random.org which is free to use.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study, power analysis has not been done

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/04/2018
Date of last participant enrolment
Anticipated
2/07/2018
Actual
Date of last data collection
Anticipated
6/08/2018
Actual
Sample size
Target
40
Accrual to date
8
Final
Recruitment outside Australia
Country [1] 9427 0
New Zealand
State/province [1] 9427 0
Canterbury

Funding & Sponsors
Funding source category [1] 298207 0
Hospital
Name [1] 298207 0
St Georges Hospial, Christchurch
Country [1] 298207 0
New Zealand
Primary sponsor type
Individual
Name
Professor Gary Hooper
Address
Leinster Orthopaedic Centre
Leinster Chambers
165 Leinster Road
Strowan
Christchurch 8014
Country
New Zealand
Secondary sponsor category [1] 297306 0
Individual
Name [1] 297306 0
Dr Micheal Douglas
Address [1] 297306 0
Christchurch Public Hospital
2 Riccarton Ave
Christchurch Central
Christchurch 8011
Country [1] 297306 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299214 0
Health and Disability Ethics Committees New Zealand
Ethics committee address [1] 299214 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 299214 0
New Zealand
Date submitted for ethics approval [1] 299214 0
14/12/2017
Approval date [1] 299214 0
27/03/2018
Ethics approval number [1] 299214 0
18/STH/10

Summary
Brief summary
Arthroscopic meniscectomy is an established procedure with known benefits in the correct patient population. Common complications associated with arthroscopic knee procedures are haemarthrosis, swelling, decreased range of motion, increased pain and infection. Previous methods for decreasing postoperative haemarthrosis and swelling have been drain placement and compressive dressings.

TXA is a lysine based inhibitor of plasminogen to plasmin which has gained popularity in orthopaedic practice in the past decade after being shown to decrease blood loss. TXA administered intravenously has also been shown as safe with regards to events such as venous thromboembolism (VTE) and acute renal failure.

A recent double blinded level 1 evidence prospective randomized controlled trial has also shown the benefit of TXA in arthroscopic ACL reconstructions in reducing postoperative hemarthrosis, swelling, and pain while increasing function in the short term.

The safety of TXA has been well documented in the orthopaedic literature as well as other surgical fields for the purpose of reduction of blood loss. In 2006, a Cochrane review that included 65 trials that compared TXA versus control. These trials included a total of 4842 patients and showed that the use of TXA was not associated with an increased risk of MI, stroke, deep vein thrombosis (DVT), pulmonary embolism (PE) or renal failure. Specifically in the orthopaedic literature, a meta analysis compared the rate of VTE in patients undergoing knee and hip arthroplasty, none showing an increased risk of VTE associated with the use of TXA compared to control. Further to this, there are large joint registry retrospective cohort studies that have also shown no association with the use of TXA and increased risk of VTE.

The goal of this pilot study is to determine if there is a role for TXA in improving short term results and patient satisfaction in arthroscopic knee meniscectomies.
Trial website
None
Trial related presentations / publications
None
Public notes
Patients will be paying for their care and medications

Contacts
Principal investigator
Name 79682 0
Prof Gary Hooper
Address 79682 0
Leinster Orthopaedic Centre
Leinster Chambers
165 Leinster Road
Strowan
Christchurch 8014
Country 79682 0
New Zealand
Phone 79682 0
+64274326263
Fax 79682 0
Email 79682 0
[email protected]
Contact person for public queries
Name 79683 0
Dr Micheal Douglas
Address 79683 0
Christchurch Public Hospital
2 Riccarton Ave
Christchurch Central
Christchurch 8011
Country 79683 0
New Zealand
Phone 79683 0
+64220242162
Fax 79683 0
Email 79683 0
[email protected]
Contact person for scientific queries
Name 79684 0
Dr Micheal Douglas
Address 79684 0
Christhchurch Hospital
2 Riccarton Ave
Christchurch Central
Christchurch 8011
Country 79684 0
New Zealand
Phone 79684 0
+64220242162
Fax 79684 0
Email 79684 0
[email protected]

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

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

Documents added automatically
No additional documents have been identified.