Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000262808p
Ethics application status
Submitted, not yet approved
Date submitted
14/12/2020
Date registered
10/03/2021
Date last updated
4/04/2022
Date data sharing statement initially provided
10/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of stiff sole shoes vs flexible sole shoes (sneakers) on foot and ankle function in patients undergoing forefoot surgery
Scientific title
Comparison of Rigid Flat Shoes Versus Flexible Sole Shoes on Foot and Ankle Function in Patients Undergoing Forefoot Surgical Treatment (ComForT)
Secondary ID [1] 303018 0
None
Universal Trial Number (UTN)
U1111-1262-7024
Trial acronym
ComForT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Forefoot Surgery 320082 0
Condition category
Condition code
Surgery 318012 318012 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comfortable lace up shoes (e.g. sneaker) owned by the participant will be worn 2 weeks after surgery. The shoes will be worn while the patient is weight bearing, i.e. walking for any length of time. The shoes may be removed for sleeping or when the patient is not weight bearing. This will start at 2 weeks post surgery. This will be needed for at least unto 6 weeks after surgery. As these are the patient's own lace up shoes, they may continue to wear these in the future as they wish. The intervention will administered by the orthopaedic surgeon/staff in the clinic at their 2 weeks post surgery visit. The patient will be reminded to bring their shoes to this visit. Adherence will not be measured
Intervention code [1] 319306 0
Treatment: Other
Comparator / control treatment
Immediately post surgery, the patient will be placed in a stiff sole shoe (provided by the hospital) by the orthopaedic surgeon. The patient will be discharged with this stiff sole shoe. The patient will continue to wear this while weight bearing i.e. walking. This will be administered by the orthopaedic surgeon in the operating room after surgery. Adherence will not be measured
Control group
Active

Outcomes
Primary outcome [1] 326008 0
100 point visual analogue score for pain
Timepoint [1] 326008 0
6 weeks post surgery
Secondary outcome [1] 389837 0
modified 5 point likert satisfaction questionnaire will measure patient satisfaction with the specific shoe type
Timepoint [1] 389837 0
6 weeks post surgery
Secondary outcome [2] 389838 0
radiographic analysis of union for arthrodesis/correction of hallux valgus
Timepoint [2] 389838 0
1 year post surgery
Secondary outcome [3] 389839 0
Adverse events e.g. blisters, paraesthesia, DVTs, PEs, infection. This will be collected when assessing the patient directly
Timepoint [3] 389839 0
6 weeks post surgery of the participant
Secondary outcome [4] 391180 0
Foot and Ankle Outcome Score (FAOS). This is a validated composite patient reported outcome measure
Timepoint [4] 391180 0
3 months post surgery of the participant
Secondary outcome [5] 391181 0
Foot and Ankle Outcome Score (FAOS)
Timepoint [5] 391181 0
6 months post surgery of the participant
Secondary outcome [6] 391182 0
Foot and Ankle Outcomes Score (FAOS)
Timepoint [6] 391182 0
12 months post surgery of the participant
Secondary outcome [7] 392557 0
General Health using the VR-12 general health survey
Timepoint [7] 392557 0
at 3 months post surgery of the participant

Eligibility
Key inclusion criteria
Patients between the ages of 18 to 80 (inclusive) undergoing 1st ray surgery surgery (either scarf and akin osteotomies for hallux valgus correction or first MTP joint fusion) will be recruited. Patients undergoing concomitant additional forefoot procedures (such as interphalangeal joint (IPJ) fusion of lesser toes, soft tissue corrective procedures, or excision of Morton’s neuroma) will be included.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be bilateral surgery, revision procedures, additional foot arthrodesis or osteotomy procedures performed proximal to the forefoot, not willing to participate in the trial, cognitive impairment that may impair the patient’s ability to follow post-operative instructions or unable to provide informed consent

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 sequentially labelled envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random number generators
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Continuous variables will be assessed using T test, while categorical ones will be assessed using non-parametric tests

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 32261 0
2060 - North Sydney

Funding & Sponsors
Funding source category [1] 307429 0
Self funded/Unfunded
Name [1] 307429 0
Andrew Wines
Country [1] 307429 0
Australia
Primary sponsor type
Individual
Name
Andrew Wines
Address
Suite G02, Mater Clinic
3 Gillies Street
Wollstonecraft NSW 2065
Country
Australia
Secondary sponsor category [1] 308420 0
None
Name [1] 308420 0
Address [1] 308420 0
Country [1] 308420 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 307511 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 307511 0
97-105 Boundary Street
Darlinghurst NSW 2010
Ethics committee country [1] 307511 0
Australia
Date submitted for ethics approval [1] 307511 0
08/02/2021
Approval date [1] 307511 0
Ethics approval number [1] 307511 0

Summary
Brief summary
With novel surgical techniques and hardware design, plaster casts are not necessary to immobilise feet after 1st metatarsal surgery. Most surgeons support the use of a stiff sole post-operative shoe in either partial or full weight bearing to protect the surgical site and prevent complications over the course of 6 weeks post-surgery. We have previously demonstrated the use of rigid flat shoes improves satisfaction over the use of reverse camber shoe. The purpose of this study is to assess whether the use of comfortable shoes vs stiff sole shoes affects patient reported outcomes. Differences in long-term surgical outcomes of non-union and recurrence will also be investigated.
Trial website
Trial related presentations / publications
Public notes
None

Contacts
Principal investigator
Name 107498 0
Dr Rajat Mittal
Address 107498 0
Suite 10
Mons road
Westmead Private Hospital
Westmead, 2145, NSW
Country 107498 0
Australia
Phone 107498 0
+61 2 8755 2644
Fax 107498 0
Email 107498 0
[email protected]
Contact person for public queries
Name 107499 0
Dr Rajat Mittal
Address 107499 0
Suite 10
Mons road
Westmead Private Hospital
Westmead, 2145, NSW
Country 107499 0
Australia
Phone 107499 0
+61 2 8755 2644
Fax 107499 0
Email 107499 0
[email protected]
Contact person for scientific queries
Name 107500 0
Dr Rajat Mittal
Address 107500 0
Suite 10
Mons road
Westmead Private Hospital
Westmead, 2145, NSW
Country 107500 0
Australia
Phone 107500 0
+61 2 8755 2644
Fax 107500 0
Email 107500 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
For privacy reasons, individual patient data will not be made available


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.