Feasibility of Other Orthosis for Talipes (FOOT) trial
Research type
Research Study
Full title
Feasibility study for a randomisation trial of a new abduction orthosis for patients with Ponseti treated Congenital Talipes Equinovarus.
IRAS ID
159993
Contact name
Nigel Kiely
Contact email
Sponsor organisation
Robert Jones and Agnes Hunt (RJAH) Hospital
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Congenital talipes equinovarus (CTEV) is the commonest limb deformity affecting newborn children in the UK. It can be corrected using a technique called the Ponseti method which involves a series of manipulations, plaster casts and a small operation. The child must then wear a ‘boots and bar’ device (orthosis) where the feet are maintained in the desired position by a bar connecting the child’s boots preventing movement of the feet. This orthosis is worn for 23 hours a day for 3 months and overnight until the age of 5 to maintain correction of the foot position. It is important that the child and their family use the orthosis to avoid recurrent deformity requiring further plaster casts or surgery. In 2014 the Abduction Dorsiflexion Mechanism (ADM) came to market as a new treatment for CTEV. Unlike the traditional orthosis the ADM doesn’t require a bar or constrain the patient’s foot; moreover patients with one affected foot need only to use the ADM on that foot whilst currently both feet need to be in the ‘boots and bar’. The aim of this study is to establish the feasibility of running a large, long-term, multi-centre study to determine if the outcomes of treating CTEV with the new ADM device are equivalent to those using the traditional ‘boots and bar’. This study will assess willingness of consultants and parents/guardians of children with CTEV to take part in such a study, what outcomes are most important to the consultants and parents/guardians, and it will establish consensus from the consultants on study design. In addition we will gain experience of the ADM device in a normal clinical setting by recruiting children with CTEV (affecting only one foot) and whose families report good compliance with the traditional device to use the ADM for 3 months.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
15/WM/0142
Date of REC Opinion
18 May 2015
REC opinion
Further Information Favourable Opinion