Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001107617p
Ethics application status
Submitted, not yet approved
Date submitted
19/09/2023
Date registered
24/10/2023
Date last updated
24/10/2023
Date data sharing statement initially provided
24/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
What is the appropriate time for weight bearing after ankle surgery?
Scientific title
Comparing Immediate Weight Bearing with Delayed Weight Bearing in Patients with Ankle Fractures Treated with Open Reduction Internal Fixation – a Randomised Control Pilot Trial Investigating the Feasibility of a Definitive RCT
Secondary ID [1] 310558 0
None
Universal Trial Number (UTN)
U1111-1297-6747
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ankle fractures 331390 0
Condition category
Condition code
Injuries and Accidents 328153 328153 0 0
Fractures
Physical Medicine / Rehabilitation 328425 328425 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Immediate Weight Bearing (IWB) group:
Patients will receive pre-operative x-rays and CT scans as required. They will be treated by orthopaedic registrars, fellows or consultants according to their preferred techniques. After surgery, all included patients will be placed in a moonboot. They will be instructed to keep their moonboots on at all times, and to keep their wounds dry.

Patients in the IWB group will be encouraged to fully weight bear within 24 hours which means they should stand or walk without using walking aids. It is envisaged that patients in the IWB group will self-limit the amount of weight they put through their ankle based on their pain tolerance and physical fitness. If necessary, walking aids (crutches, walking frames etc.) will be provided as determined by the treating doctors, nurses, physiotherapists and occupational therapists.

Patients will document the date that they are able to fully weight bear without walking aids in the provided reporting log for assessment purpose. Adherence to weight bearing status will be assessed through participants interviews at the end of the study.
Intervention code [1] 326964 0
Rehabilitation
Comparator / control treatment
Delayed Weight Bearing (DWB) group:
Patients will receive pre-operative x-rays and CT scans as required. They will be treated by orthopaedic registrars, fellows or consultants according to their preferred techniques. After surgery, all included patients will be placed in a moonboot. They will be instructed to keep their moonboots on at all times, and to keep their wounds dry.

Patients in the DWB group will use walking aids (crutches, walking frames etc.) for mobilising and remain non-weight bearing for six weeks prior to allowing full weight bearing.

Patients will document the date that they are able to fully weight bear without walking aids in the provided reporting log for assessment purpose. Adherence to non-weight bearing status will be assessed through participants interviews at the end of the study.
Control group
Active

Outcomes
Primary outcome [1] 336029 0
Recruitment rate: We will use eligibility criteria log to screen participants. We will document the number of participants who were screened and the number of eligible participants who agreed to be randomised in an Excel spreadsheet. The recruitment rate will be calculated as the proportion of enrolled participants to screened participants and the number of enrolled participants per month.
Timepoint [1] 336029 0
At 6 months post-surgery.
Primary outcome [2] 336030 0
Adherence rate: This will be identified by the proportion of participants who followed the weight bearing status to all participants at their allocated arm. This will be recorded through participant self-report during an interview meeting at the end of the study.
Timepoint [2] 336030 0
At 6 months post-surgery.
Primary outcome [3] 336031 0
Drop-out rate: The data related to participants who withdraw from the study will be documented in the Excel spreadsheet. The drop-out will be reported as the proportion of participants who withdraw to those who initially enrolled in the study.
Timepoint [3] 336031 0
At 6 months post-surgery.
Secondary outcome [1] 426511 0
Function using Olerud and Molander Ankle Score (OMAS), scoring from 0-100, with higher score representing a perfect ankle. (This will be the primary outcome in the full RCT).
Timepoint [1] 426511 0
At 6 weeks, 3 months, and 6 months post-surgery.
Secondary outcome [2] 426512 0
Function using Self-Reported Foot and Ankle Score (SEFAS), scoring from 0-48 with higher score indicating the most favourable outcome.
Timepoint [2] 426512 0
At 6 weeks, 3 months and 6 months post-surgery.
Secondary outcome [3] 426513 0
Quality of life using SF-36, scoring from 0-100 with higher scores representing better quality of life.
Timepoint [3] 426513 0
At 6 weeks, 3 months and 6 months post-surgery.
Secondary outcome [4] 426514 0
Time to return to work as recorded in participant reporting log.
Timepoint [4] 426514 0
It will be followed up to 6 months post-surgery.
Secondary outcome [5] 426515 0
Time to full weight bearing as recorded in participant reporting log.
Timepoint [5] 426515 0
It will be followed up to 6 months post-surgery.
Secondary outcome [6] 426518 0
Time to return to pre-injury activities as recorded in participant reporting log.
Timepoint [6] 426518 0
It will be followed up to 6 months post-surgery.
Secondary outcome [7] 426520 0
Total complication: This will be a composite data comprising all complications including wound infection, venous thromboembolism, loss of reduction, fracture malunion, non-union and implant failure. During in each assessment timepoint, we will record patient complications from their medical record. At the end of the study, total complication rate will be calculated as the ratio of patients with complications (binary data Yes/No) to the total number of patients.
Timepoint [7] 426520 0
At 6 months post-surgery.
Secondary outcome [8] 426522 0
Wound complications: (a report of either superficial, deep wound infection or wound dehiscence). This will be collected from surgeon reports during patient follow up visits.
Timepoint [8] 426522 0
At 2 weeks post-surgery.
Secondary outcome [9] 426523 0
Venus thromboembolism: This will be collected from surgeon's report from patient hospital medical record.
Timepoint [9] 426523 0
This will be followed during the hospitalisation period or up to 6 weeks post-surgery.
Secondary outcome [10] 426524 0
Loss of reduction: Reduction loss will be defined as a displacement greater than 2mm compared with intraoperative images or syndesmosis widening. This will be collected from the radiologist or surgeon's X-ray interpretations.
Timepoint [10] 426524 0
At 6 weeks, 3 and 6 months post-surgery.
Secondary outcome [11] 426525 0
Implant failure requiring revision surgery: Implant failure will be a breakage of the plate or screws. This will be collected from the radiologist or surgeon report from X-ray reviews.
Timepoint [11] 426525 0
At 6 weeks, 3 and 6 months post-surgery.
Secondary outcome [12] 426526 0
Malunion and or mal-reduction (composite date): This will be collected from radiologist or surgeons interpretation of X-rays.
Timepoint [12] 426526 0
At 6 weeks, 3 and 6 months post surgery.
Secondary outcome [13] 426616 0
Non-union: Non-union will be defined the absence of radiologic evidence of healing at 6 months post operation as determined by the radiologist or operating surgeon, combined with clinical findings.
Timepoint [13] 426616 0
At 3 and 6 months post-surgery.

Eligibility
Key inclusion criteria
Unilateral ankle fractures requiring open reduction internal fixation
Fracture patterns will include with isolated medial or lateral malleolus fractures, bimalleolar and trimalleolar fractures
Closed fracture
Fractures whose post-operative stability has been confirmed by operating surgeons
Participants who are available to attend follow-up in Christchurch Hospital.
Participants must be physically active (with or without walking aids) in the community before the injury
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Fractures where stability is still questionable following fixation by the operating surgeon,
Open fracture.
Compound fracture
Pathological fracture
Non-ambulator pre-injury
Active infection at the surgical site
Concurrent injuries that preclude adhering to the follow up protocol
Inability to cooperate protocol due to neurologic disorders (i.e., cognitive impairment, substance abuse, mental illness, intellectual disability, and dense peripheral neuropathy) or significant additional physical impairment (i.e., polytrauma patients with other limb, head or visceral injuries).

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 through sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated random sequence using blocks of 4 with a 1 to 1 ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size:
As this is a preliminary pilot trial, it is not expected to assess the efficacy of intervention. Rather, we have estimated the sample size based on expected range for effect size. The minimum clinically important difference for the OMAS was reported 10.5 at three months. Considering with the average SD at 16 from a prior study, this gives a standard effect size of 0.66 (a medium effect size), a sample size of 13 participants per group would give the minimum sample size needed for the overall clinical trial program (pilot + full trial). Given a drop-out rate of 20%, we will need a total of 32 participants for this trial.


Statistical analysis:
Descriptive statistics will be used to report participants’ recruitment rate, adherence rate, and the drop-out rate. SPSS (version 28.0; IBM Corporation, Armonk, NY) will be used for statistical analysis. We will report mean and SD for continuous data (OMAS, SEFAS, SF-36, time to full weight bearing, time to return to work and pre-injury activities) and percentage or number for categorical data (total and individual complications).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment outside Australia
Country [1] 25761 0
New Zealand
State/province [1] 25761 0
Canterbury

Funding & Sponsors
Funding source category [1] 314762 0
Government body
Name [1] 314762 0
Health Research Council of New Zealand (hrc nz)
Country [1] 314762 0
New Zealand
Primary sponsor type
Individual
Name
Blair Mason
Address
Orthopaedic Surgery, Christchurch Hospital, 2 Riccarton Ave, city centre, 8011
Country
New Zealand
Secondary sponsor category [1] 316746 0
Individual
Name [1] 316746 0
Zohreh Jafarian Tangrood
Address [1] 316746 0
Orthopaedic Surgery and Musculoskeletal Medicine Department, Christchurch Hospital, 2 Riccarton Ave, city centre, 8011
Country [1] 316746 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313770 0
Northern Health and Disability Ethics Committees
Ethics committee address [1] 313770 0
Ethics committee country [1] 313770 0
New Zealand
Date submitted for ethics approval [1] 313770 0
16/10/2023
Approval date [1] 313770 0
Ethics approval number [1] 313770 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129306 0
Dr Blair Mason
Address 129306 0
Orthopaedic Surgery, Christchurch Hospital, 2 Riccarton Ave, city centre, 8011
Country 129306 0
New Zealand
Phone 129306 0
+64274384161
Fax 129306 0
Email 129306 0
[email protected]
Contact person for public queries
Name 129307 0
Zohreh Jafarian Tangrood
Address 129307 0
Department of Musculoskeletal surgery, Christchurch Hospital, 2 Riccarton Ave, city centre, 8011
Country 129307 0
New Zealand
Phone 129307 0
+64 223013366
Fax 129307 0
Email 129307 0
[email protected]
Contact person for scientific queries
Name 129308 0
Blair Mason
Address 129308 0
Orthopaedic Surgery, Christchurch Hospital, 2 Riccarton Ave. city centre, 8011
Country 129308 0
New Zealand
Phone 129308 0
+64274384161
Fax 129308 0
Email 129308 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be presented for each group as mean and SD. During data analysis, we will use code to maintain participants' confidentiality.


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.