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
ACTRN12618001281280p
Ethics application status
Not yet submitted
Date submitted
24/07/2018
Date registered
30/07/2018
Date last updated
30/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of shoe insert intervention on participants following first metatarsal distal osteotomies with fixation.
Scientific title
The effectiveness of shoe insert intervention following first metatarsal distal osteotomies with fixation.
Secondary ID [1] 295654 0
Nil
Universal Trial Number (UTN)
U1111-1217-9842
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bunions 308990 0
hallux rigidus 308991 0
Hallux limitus 309009 0
Condition category
Condition code
Surgery 307893 307893 0 0
Other surgery
Musculoskeletal 307908 307908 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 307909 307909 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Shoe insert intervention following first metatarsal distal osteotomies with fixation.
1. Group 1: Orthotic intervention 6 weeks after osteotomy (20 participants).
Group 2: Orthotic intervention 12 weeks after osteotomy (20 participants).
Group 3: Sham orthotics at either 6 or 12 weeks after osteotomy (10 participants in each group).
2. A standard full length pre-fabricated orthotic will be used (footbionics).
3. Surgeons and the administering podiatrist will be monitoring the intervention.
4. Duration of wear will be 6 weeks and will be on a daily basis for at least 80% of daily gait.
5. There will be a diary to record and assess adherence to the orthotic intervention.
Intervention code [1] 301966 0
Treatment: Devices
Intervention code [2] 301967 0
Rehabilitation
Comparator / control treatment
1. Sham orthoses: a cushioning non-biomechanically altering insole that will not add support to the foot.
2. The main comparison being made is between early vs late orthotic intervention, but will also use a control group to see if only cushioning devices work just as well in either groups (early and late).
Control group
Active

Outcomes
Primary outcome [1] 306895 0
1. changes in pain will be assessed by foot health status questionnaire (FHSQ). A change of 3 or more points will be significant.
Timepoint [1] 306895 0
6 months
Secondary outcome [1] 350046 0
2. Change in Range of Motion will be assessed by a hand held angle finder the researcher will place on the participants toe. This will be done before and after surgery and before and after receiving your shoe inserts. A change of more than 5 degree will be significant.
Timepoint [1] 350046 0
6 months

Eligibility
Key inclusion criteria
If you are having a first metatarsal distal osteotomies with fixation and have a flat foot type as determined through assessment by a researcher and are over 18 years of age you are eligible for inclusion in this study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If first metatarsal distal osteotomies with fixation is combined with other forefoot procedures the patient will be excluded from the study.

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 envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/08/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/03/2019
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300234 0
Other
Name [1] 300234 0
Fayad podiatry clinic
Country [1] 300234 0
Australia
Primary sponsor type
Other
Name
Fayad podiatry clinic
Address
Heel to Toe Podiatry
Shop 1069A Stockland Mall, 199-201 Pitt Street, Merrylands NSW 2160.
Country
Australia
Secondary sponsor category [1] 299688 0
None
Name [1] 299688 0
Address [1] 299688 0
Country [1] 299688 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 301057 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 301057 0
University Drive, Callaghan
NSW 2308, Australia
Ethics committee country [1] 301057 0
Australia
Date submitted for ethics approval [1] 301057 0
06/08/2018
Approval date [1] 301057 0
Ethics approval number [1] 301057 0

Summary
Brief summary
Shoe inserts may be used after surgery for bunions and are proposed to help support the foot, reduce pain and improve the movement in the first toe joint. However it is unknown whether having shoe inserts soon after surgery or waiting for complete healing is better to achieve these outcomes. This study will investigate if early (6 week) intervention or later (12 week) intervention with shoe inserts is better for improving first toe joint pain and range of motion following a first metatarsal distal osteotomy with fixation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85738 0
Mr Usama Fayad
Address 85738 0
Heel to toe podiatry
Shop 1069A Stockland Mall, 199-201 Pitt Street, Merrylands NSW 2160
Country 85738 0
Australia
Phone 85738 0
+61 416633445
Fax 85738 0
Email 85738 0
[email protected]
Contact person for public queries
Name 85739 0
Mr Usama Fayad
Address 85739 0
Heel to toe podiatry
Shop 1069A Stockland Mall, 199-201 Pitt Street, Merrylands NSW 2160
Country 85739 0
Australia
Phone 85739 0
+61 416633445
Fax 85739 0
Email 85739 0
[email protected]
Contact person for scientific queries
Name 85740 0
Mr Usama Fayad
Address 85740 0
Heel to toe podiatry
Shop 1069A Stockland Mall, 199-201 Pitt Street, Merrylands NSW 2160
Country 85740 0
Australia
Phone 85740 0
+61 416633445
Fax 85740 0
Email 85740 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.