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Trial registered on ANZCTR


Registration number
ACTRN12617000200381
Ethics application status
Approved
Date submitted
11/01/2017
Date registered
6/02/2017
Date last updated
22/01/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial comparing post operative shoes following surgery of the first ray
Scientific title
FORFoot: A randomised controlled trial of clinical and radiological outcomes comparing reverse camber forefoot offloading shoes with rigid flat soled shoes in adult patients with surgery of the first ray:
Secondary ID [1] 290869 0
nil known
Universal Trial Number (UTN)
Trial acronym
Forefoot Offloader vs Rigid flat shoe in forefoot surgery (FORfoot)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
musculoskeletal- first ray surgery 301564 0
Condition category
Condition code
Musculoskeletal 301278 301278 0 0
Other muscular and skeletal disorders
Surgery 301349 301349 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
intervention - rigid flat soled post operative shoe

- The intervention group receive a rigid flat soled shoe. This is a stable device enabling near normal gait at the cost of putting pressure through the operated first ray. Patients will be given an information leaflet summarising the risks and benefits of a rigid flat post operative shoe when compared to the control which allows offloading of the operated forefoot and the expense of stability when mobilising.


- The only difference between groups will be the type of shoe they are given. All other operative techniques and post operative instructions will be standardised between groups. The shoe will be fitted in theatre by a trained member of the surgical team (specialist nurse or subspecialist foot and ankle fellow) and the patient will be mobilised on the ward by a trained physiotherapist and discharged when safely walking with the aid of two crutches.

The patient information leaflet will include contact details of a member of the research team that they can contact if they have any queries or concerns.

The shoe will be kept in place for 6 weeks and the only non standard post operative request will be for the patient to complete a patient reported outcome booklet containing the primary outcome measure and a secondary satisfaction measure.

At one year all patients will be requested to complete a final radiograph which is not part of standard post operative care to assess for final radiographic outcome
Intervention code [1] 296814 0
Treatment: Devices
Comparator / control treatment
control- Reverse camber post operative shoe

The reverse camber shoe is a forefoot offloading device which is currently the gold standard after forefoot surgery. This type of shoe has been shown to reduce forefoot pressure when mobilising therefore protecting the operative procedures whilst allowing mobilisation. However, there is no clinical evidence as to whether forefoot offloading is required after first ray surgery and the reverse camber shoe used as a control has issues such as abnormal gait patterns and instability leading to falls risks.
Control group
Active

Outcomes
Primary outcome [1] 300690 0
100 point visual analogue score for pain
Timepoint [1] 300690 0
6 weeks post surgery
Secondary outcome [1] 330620 0
modified 5 point likert satisfaction questionnaire
Timepoint [1] 330620 0
6 weeks post surgery
Secondary outcome [2] 330623 0
radiographic analysis of union for arthrodesis
Timepoint [2] 330623 0
12 months post surgery
Secondary outcome [3] 330779 0
radiographic analysis of correction for hallux valgus
Timepoint [3] 330779 0
12 months post surgery

Eligibility
Key inclusion criteria
primary surgery of the first ray- arthrodesis of the 1st metatarsophalangeal joint or scarf/akin osteotomy for hallux valgus
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
revision surgery
bilateral surgery
first ray procedures other than those listed in the inclusion criteria (such as a lapidus fusion, dorsal cheilectomy and simple bunionectomy)

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary endpoint is a 100 point visual analogue score for pain. Previous studies have shown that the minimal clinical important difference in a (VAS) pain is around 20 points. To be certain there was no significant difference in pain between the groups we designed the study to detect a treatment effect of 10 points. Using mean pain relief and standard deviations from a recent study of first ray surgery we designed the study with 80% power at the 5% significance level. which required data from 84 patients. To allow for 10% loss to follow up we aim to recruit 100 patients.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
19/02/2016
Date of last participant enrolment
Anticipated
22/06/2017
Actual
27/11/2017
Date of last data collection
Anticipated
13/06/2018
Actual
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7240 0
North Shore Private Hospital - St Leonards
Recruitment hospital [2] 7241 0
Castlecrag Private Hospital - Castlecrag
Recruitment postcode(s) [1] 15005 0
2065 - St Leonards
Recruitment postcode(s) [2] 15006 0
2068 - Castlecrag

Funding & Sponsors
Funding source category [1] 295339 0
Self funded/Unfunded
Name [1] 295339 0
Dr Andrew P Wines
Country [1] 295339 0
Australia
Primary sponsor type
Individual
Name
Dr Andrew P Wines
Address
Suite G02, Mater Clinic
3 Gillies Street
Wollstonecraft NSW 2065
Country
Australia
Secondary sponsor category [1] 294164 0
None
Name [1] 294164 0
Address [1] 294164 0
Country [1] 294164 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296635 0
North Shore Private Hospital Ethics Committee
Ethics committee address [1] 296635 0
Ethics committee country [1] 296635 0
Australia
Date submitted for ethics approval [1] 296635 0
Approval date [1] 296635 0
02/11/2015
Ethics approval number [1] 296635 0
NSPHEC 2015-015

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

Contacts
Principal investigator
Name 71574 0
Dr Andrew P Wines
Address 71574 0
North Sydney Orthopaedics and Sports Medicine Centre,
Mater clinic, 3 Gillies st,
Crows Nest NSW 2065
Country 71574 0
Australia
Phone 71574 0
+61 2 94090500
Fax 71574 0
Email 71574 0
andrew@drapwines.com.au
Contact person for public queries
Name 71575 0
Frances Stewart
Address 71575 0
North Sydney Orthopaedics and Sports Medicine Centre,
Mater clinic, 3 Gillies st,
Crows Nest NSW 2065
Country 71575 0
Australia
Phone 71575 0
+61 2 94090500
Fax 71575 0
Email 71575 0
frances@drapwines.com.au
Contact person for scientific queries
Name 71576 0
Karen Fogarty
Address 71576 0
North Sydney Orthopaedics and Sports Medicine Centre,
Mater clinic, 3 Gillies st,
Crows Nest NSW 2065
Country 71576 0
Australia
Phone 71576 0
+61 2 94090500
Fax 71576 0
Email 71576 0
karenfog@optusnet.com.au

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
SourceTitleYear of PublicationDOI
EmbaseClinical and Radiological Outcomes of Forefoot Offloading Versus Rigid Flat Shoes in Patients Undergoing Surgery of the First Ray.2019https://dx.doi.org/10.1177/1071100719858621
N.B. These documents automatically identified may not have been verified by the study sponsor.