Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000465459p
Ethics application status
Submitted, not yet approved
Date submitted
30/04/2025
Date registered
16/05/2025
Date last updated
16/05/2025
Date data sharing statement initially provided
16/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing Immediate and Delayed Weight Bearing in patients with ankle fractures
Scientific title
The effectiveness of Immediate weight-bearing versus delayed weight-bearing following Open Reduction and Internal Fixation of ankle fractures on functional outcome; A multi-centre randomised control trial.
Secondary ID [1] 314310 0
None
Universal Trial Number (UTN)
U1111-1322-0347
Trial acronym
BEAR trail (Bearing Early Accelerated Recovery)
Linked study record
ACTRN12623001107617
This record is a follow-up to a previously conducted pilot trial.

Health condition
Health condition(s) or problem(s) studied:
Ankle fractures 337260 0
Condition category
Condition code
Injuries and Accidents 333661 333661 0 0
Fractures
Physical Medicine / Rehabilitation 333662 333662 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Immediate Weight Bearing (IWB) group:
Eligible patients with displaced ankle fractures treated with open reduction and internal fixation will be randomised to the immediate weight bearing group post-operatively. Patients will have their ankle immobilised in a Moonboot for 6 weeks and will not be permitted to remove the moonboot for ankle range of motion exercises during this period. Patients will be instructed to commence weight bearing from day one post-operatively. The level of weight bearing will be determined by the patient's pain tolerance and physical fitness. Walking aids will be provided by the treatment medical team (including doctors, nurses, physiotherapists, and occupational therapists). Patients will be encouraged to progressively increase their weight bearing and transition to independent walking without aids as tolerated.
Adherence to the intervention will be assessed through a combination of strategies: 1) Participant self-report during follow-up assessments, 2) Trial manager check-ins (e.g., during safety checks), where participants can raise concerns or report deviations. Any deviation from the prescribed weight bearing protocol will be documented in the follow-up completion form.
Intervention code [1] 330922 0
Rehabilitation
Comparator / control treatment
Delayed Weight Bearing (DWB) group:
Eligible patients with displaced ankle fractures treated with open reduction and internal fixation will be randomised to the delayed weight bearing group post-operatively. Patients will have their ankle immobilised in a Moonboot for 6 weeks and will not be permitted to remove the moonboot for ankle range of motion exercises during this period. Patients in the DWB group will use walking aids such as crutches, walking frames, or knee scooter for mobilising and remain non-weight bearing for six weeks prior to allowing full weight bearing.
Adherence to the intervention will be assessed through a combination of strategies: 1) Participant self-report during follow-up assessments, 2) Trial manager check-ins (e.g., during safety checks), where participants can raise concerns or report deviations. Any deviation from the prescribed weight bearing protocol will be documented in the follow-up completion form.
Control group
Active

Outcomes
Primary outcome [1] 341259 0
Function using Self-Reported Foot and Ankle Score (SEFAS).
Timepoint [1] 341259 0
Assessed at 6 weeks, 3 months and 6 months post-surgery.
Secondary outcome [1] 446923 0
Function using Olerud and Molander Ankle Score (OMAS).
Timepoint [1] 446923 0
Assessed at 6 weeks, 3 months and 6 months post-surgery.
Secondary outcome [2] 446924 0
Short Form-36 (SF-36) Health Survey
Timepoint [2] 446924 0
Assessed at 6 weeks, 3 months, and 6 months post-sugrery.
Secondary outcome [3] 446925 0
Total complications
Timepoint [3] 446925 0
Assessed at 6 months post-surgery.
Secondary outcome [4] 446926 0
Venous thromboembolism
Timepoint [4] 446926 0
Assessed at patient routine hospital visits up to 6 months post-surgery.
Secondary outcome [5] 446928 0
Superficial wound infection
Timepoint [5] 446928 0
Assessed at 2 weeks and up to 6 weeks post-surgery.
Secondary outcome [6] 446930 0
Deep wound infection and wound dehiscence (composite data)
Timepoint [6] 446930 0
Assessed up to 6 months post-surgery.
Secondary outcome [7] 446932 0
Loss of reduction
Timepoint [7] 446932 0
Assessed up to 3 months post-surgery.
Secondary outcome [8] 446933 0
Malunion
Timepoint [8] 446933 0
Assessed between 3 and 6 months post-surgery.
Secondary outcome [9] 446934 0
Delayed union
Timepoint [9] 446934 0
It will be collected up to 6 months post-surgery.
Secondary outcome [10] 446936 0
Implant failure
Timepoint [10] 446936 0
Assessed up to 6 months post-surgery.
Secondary outcome [11] 446937 0
Time to full weight bearing
Timepoint [11] 446937 0
Assesed up to 6 months post-surgery.
Secondary outcome [12] 446938 0
Time to return to pre-injury activities
Timepoint [12] 446938 0
Assessed up to 6 months post-surgery.
Secondary outcome [13] 446939 0
Time to return to sport
Timepoint [13] 446939 0
Assessed up to 6 months post-surgery.
Secondary outcome [14] 446940 0
Time to return to work from date of injury
Timepoint [14] 446940 0
Assessed up to 6 months post-surgery.

Eligibility
Key inclusion criteria
Patients with unilateral closed ankle fractures treated with open reduction internal fixation will be included.
Eligible fracture pattern will be Isolated malleolar fracture (including medial, lateral, or posterior malleolus fractures), bimalleolar and trimalleolar fractures.
Patients treated with an external fixator before ORIF remain eligible. These fracture patterns will be eligible if post-operative stability is confirmed by operating surgeons.
Patients must have been ambulatory with or without walking aids before injury.


Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Key exclusion criteria
1) Fractures with questionable stability after fixation as determined by the surgeon.
2) Pilon fractures,
3) patients require syndesmotic fixation
4) patients with concurrent injuries preventing protocol adherence
5) Pathological fracture
6) Compound fracture
7) Patients with neurological disorders (e.g., severe cognitive impairment, substance abuse, intellectual disability).
8) Patients with dense peripheral neuropathy.
9) Patients with significant additional physical impairments (e.g., polytrauma patients).

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)
Randomisation will be conducted using REDCap, ensuring that allocation concealment is maintained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated random sequence will be used for randomisation, with blocks of size 4 to ensure balanced allocation. The allocation ratio will be 1:1, meaning participants will have an equal chance of being assigned to each group.
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
The smallest detectable difference for the SEFAS that can be detected beyond the measurement error was reported 5 at three months (Cöster et al., 2017). Considering the average standard deviation at 9, this gives a sample size of 70 per group for the main trial to achieve 90% power at a two-sided alpha of 0.05. Given a 10% drop-out, we will need a total of 154 participants for the full trial. To minimise the sample size required, the data collected from 32 participants in the pilot trial will be added to the full trial. Therefore, overall, we will need an additional 122 participants for the full trial.

Statistical analysis
Participant demographics and clinical characteristics measured at baseline will be summarised using simple descriptive statistics by treatment group. The between-group difference in the primary outcome (SEFAS measured at 3 months) will be estimated with 95% confidence intervals, and p value calculated using a 2-sample t-test. Secondary continuous outcomes (OMAS and SF-36) will be treated in a similar manner. Time to full weight bearing, return to pre-injury activities and return to work for those with physical job demands will be calculated as weeks from the operation and compared between treatment groups using semiparametric or parametric survival analysis models as appropriate. The number of participants experiencing complications, including wound infections and hardware failures, will be reported for each group and compared using Chi Square or Fisher’s exact tests. A P-value of less than 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
30/09/2027
Actual
Date of last data collection
Anticipated
28/07/2028
Actual
Sample size
Target
154
Accrual to date
Final
Recruitment outside Australia
Country [1] 27022 0
New Zealand
State/province [1] 27022 0
Canterbury

Funding & Sponsors
Funding source category [1] 318832 0
Charities/Societies/Foundations
Name [1] 318832 0
Wishbone Orthopaedic Research Foundation of New Zealand
Country [1] 318832 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 321280 0
None
Name [1] 321280 0
Address [1] 321280 0
Country [1] 321280 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317448 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 317448 0
Ethics committee country [1] 317448 0
New Zealand
Date submitted for ethics approval [1] 317448 0
08/05/2025
Approval date [1] 317448 0
Ethics approval number [1] 317448 0

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

Contacts
Principal investigator
Name 141066 0
Dr Helen Ignoe
Address 141066 0
University of Otago, 2 Riccarton Avenue, City Centre, Christchurch 8011
Country 141066 0
New Zealand
Phone 141066 0
+64 212405017
Fax 141066 0
Email 141066 0
[email protected]
Contact person for public queries
Name 141067 0
Zohreh Jafarian Tangrood
Address 141067 0
University of Otago, 2 Riccarton Avenue, City Centre, Christchurch 8011
Country 141067 0
New Zealand
Phone 141067 0
+64 223013366
Fax 141067 0
Email 141067 0
[email protected]
Contact person for scientific queries
Name 141068 0
Zohreh Jafarian Tangrood
Address 141068 0
University of Otago, 2 Riccarton Avenue, City Centre, Christchurch 8011
Country 141068 0
New Zealand
Phone 141068 0
+64 223013366
Fax 141068 0
Email 141068 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.