A Comparison of Patient Satisfaction Between Darco, Podalux and Standard Dressing Shoes Following Forefoot Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 83
- Locations
- 2
- Primary Endpoint
- Manchester-Oxford Foot Questionnaire (Outcome measure looking at foot pain,and function)
Study Overview
Brief Summary
This study compares patient satisfaction in terms of pain relief, mobility and ease of use between 3 commonly used types of post-surgical footwear. This study randomises patients who participate into one of 3 groups of footwear, namely Darco, Podalux or standard dressing shoe. Number of patients enrolled is determined by power calculation. Patients complete a single, simple previously validated questionnaire the MOXFQ (Manchester-Oxford Foot Questionnaire) at their 6 week follow-up appointment and statistical differences between the group are calculated using a significance level of p<0.05. This study will help us determine the best foot-wear to offer the investigators post-surgical patients.
This study will form original research.
Detailed Description
Methodology:
This will be a randomised trial with three arms: 1. Darco, 2. Podalux, 3. Standard dressing shoe.
Design:
A randomised controlled trial will ensure that shoes are distributed without surgeon bias, and will be performed prior to surgery by the principle investigator. Baseline differences will be assessed for by administration of a pre-operative MOXFQ score prior to randomisation. Primary outcome measure will be difference in score between groups post-operatively, however we will also analyse the absolute change in score between groups, although this we do not feel can be the primary outcome measure as the major reason for the change in MOXFQ from pre to post operation will be the surgery itself.
Blinding and randomisation:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients over 18 years age
- •Patients normally independently mobile
- •Patients with no significant co-morbidities that would be expected to affect normal ambulation
- •Patients undergoing straightforward 1st ray surgery eg. 1st MTPJ arthrodesis, 1st metatarsal osteotomy, (in combination with 2nd ray procedures allowed)
- •Patients able to understand and complete questionnaires
Exclusion Criteria
- •Patients under 18 years age
- •Patients not independently mobile
- •Patients with significant co-morbidities that effect normal ambulation (eg hip arthritis)
- •Patients undergoing complicated forefoot reconstructive surgery or surgery on rays other then 1st and 2nd.
- •Patients unable to understand or complete self-administered questionnaires
Arms & Interventions
Standard dressing shoe
Standard dressing shoe
Intervention: Standard dressing shoe (Device)
Darco shoe
Darco walking shoe provided
Intervention: Darco shoe (Device)
Podalux Shoe
Podalus shoe
Intervention: Podalux shoe (Device)
Outcomes
Primary Outcomes
Manchester-Oxford Foot Questionnaire (Outcome measure looking at foot pain,and function)
Time Frame: Change from baseline at 6 weeks post-operative
Differences between the 2 groups in change from baseline in questionnaire score at 6 weeks post operative
Secondary Outcomes
- Surgical Shoe Questionnaire(6 weeks post-operative)