Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001090101p
Ethics application status
Submitted, not yet approved
Date submitted
5/07/2019
Date registered
7/08/2019
Date last updated
7/08/2019
Date data sharing statement initially provided
7/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Perioperative use of steroids in knee arthroplasty trial
Scientific title
The effect of perioperative use of steroids in knee arthroplasty on early recovery: A prospective blinded randomised control trial
Secondary ID [1] 298662 0
None
Universal Trial Number (UTN)
U1111-1236-5827
Trial acronym
PHUCA Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of Knee 313557 0
Condition category
Condition code
Musculoskeletal 311989 311989 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prospective randomised control trial comparing standard perioperative care for primary total knee replacement with and without the addition of perioperative doses of methylprednisolone- 125mg at induction and 12hrs postoperatively administered intravenously. Doses will be given during hospital admission and adherence to the intervention will be monitored by drug chart review.

The addition of methylprednisolone 125mg IV at induction and 12hrs postop will be the treatment intervention.
Intervention code [1] 314922 0
Treatment: Drugs
Comparator / control treatment
All patients will receive spinal anaesthesia with 0.5% Heavy Marcaine and 150mcg intrathecal morphine and light sedation with Propofol (target controlled infusion). An intraoperative infiltration of 200-400 mg 0.2% ropivacaine in 200mls, 1mcg adrenaline, 30mg ketorolac and 2g of tranexamic acid administered by the surgeon. Post operatively for four weeks patients received a buprenorphine 5mcg topical patch, paracetamol 1g four times daily and celecoxib 100mg twice per day. Patients will have access to Targin (oxycodone & naloxone), Endone (oxycodone) and tramadol for break through analgesia, doses of which were recorded.

This is the Standard protocol at SJOGM currently in place (control) and will be compared with the addition of methylprednisolone 125mg IV at induction and 12hrs postop (comparator).
The control group (placebo) will receive IV 0.9% normal saline at 12 hours post-operatively in place of the methylprednisolone.
Control group
Placebo

Outcomes
Primary outcome [1] 320633 0
Composite Outcome: Postoperative pain, nausea and vomiting
Assessment
Pain- Visual Analgue Scale, Morphine equivalent for analgesia usage
PONV- PONV Intensity Scale, Antiemetic equivalent dose
Timepoint [1] 320633 0
Hospital Admission assessed daily until day of discharge
Secondary outcome [1] 372264 0
Pain scores assessed using the visual analogue scale
Timepoint [1] 372264 0
4weeks, 3months, 1 year post-operatively
Secondary outcome [2] 372442 0
Range of motion- Physiotherapist measured using Goniometer
Timepoint [2] 372442 0
Discharge from hospital, 4weeks, 3months, 1year at routine follow up appointments

Eligibility
Key inclusion criteria
>18yo
Primary Osteoarthritis
BMI <40
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inflammatory arthritis
Prior knee surgery
Revision surgery
Infection
Diabetes - Type one and two

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)
Central randomisation by phone/fax/computer.
Patients will be randomised using a computer generated algorithm into two groups.
The surgeon performing the operation will be unaware as to which group the patient has been allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer
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
Efficacy
Statistical methods / analysis
Power study - 110 participants
To estimate the appropriate sample size, we conducted a power analysis before the study. The a level was set a priori at P = .05, and power was set at 80%. Effect size was estimated at a difference of 2 on the visual analogue scale, which was calculated based on previous study literature (Mullaji A, Kanna R, Shetty GM, Chavda V, Singh DP. Efficacy of periarticular injection of bupivacaine, fentanyl, and methylprednisolone in total knee arthroplasty. a prospective, randomized trial J Arthroplasty. 2010;25(6):85). Results of the power analysis indicated that 49 participants per group would provide sufficient power. Furthermore, we have increased this to 110 participants to assume a 10% drop out rate. Any loss to follow up will be included as part of an intention to treat analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2019
Actual
Date of last participant enrolment
Anticipated
1/03/2020
Actual
Date of last data collection
Anticipated
1/06/2020
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 303201 0
Commercial sector/Industry
Name [1] 303201 0
Orthopaedics WA
Country [1] 303201 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Orthopaedics WA
Address
Wexford Medical Centre, 15/3 Barry Marshall Parade, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 303215 0
None
Name [1] 303215 0
Nil
Address [1] 303215 0
Nil
Country [1] 303215 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303762 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 303762 0
St John of God Health Care Human Research Ethics Committee
C/o St John of God Subiaco Hospital
12 Salvado Road
Subiaco Western Australia 6008
Ethics committee country [1] 303762 0
Australia
Date submitted for ethics approval [1] 303762 0
07/07/2019
Approval date [1] 303762 0
Ethics approval number [1] 303762 0

Summary
Brief summary
This study will consist of a prospective randomised control trial comparing standard perioperative care for primary total knee replacement with and without the addition of a perioperative dose of methylprednisolone.

We aim to determine the best peri-operative pain control for patients undergoing this painful procedure whilst limiting the risks. This is hypothesised to allow early gains in range of movement, hospital discharge and reduction in post operative nausea and vomiting, postural hypotension, post operative analgesia requirements and an improvement in knee scores.

Patients will be assessed daily during their inpatient stay and then at 2 and 6 weeks for pain control, satisfaction, signs of infection and range of movement. The study will be conducted over a three month time frame.

This information will be used to enhance pain control for future patients whilst reducing risks. It is also expected to enhance the patient journey for those undergoing TKA at SJOG Murdoch.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94710 0
Dr Sheldon Moniz
Address 94710 0
Wexford Medical Centre, 15/3 Barry Marshall Parade, Murdoch WA 6150
Country 94710 0
Australia
Phone 94710 0
+61 433828016
Fax 94710 0
Email 94710 0
monizsheldon@gmail.com
Contact person for public queries
Name 94711 0
Dr Sheldon Moniz
Address 94711 0
Wexford Medical Centre, 15/3 Barry Marshall Parade, Murdoch WA 6150
Country 94711 0
Australia
Phone 94711 0
+61 433828016
Fax 94711 0
Email 94711 0
monizsheldon@gmail.com
Contact person for scientific queries
Name 94712 0
Dr Sheldon Moniz
Address 94712 0
Wexford Medical Centre, 15/3 Barry Marshall Parade, Murdoch WA 6150
Country 94712 0
Australia
Phone 94712 0
+61 433828016
Fax 94712 0
Email 94712 0
monizsheldon@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.