Status:
COMPLETED
Feasibility Study on Using Smart Templates, That Link Rectification Approaches to Particular Patient Characteristics, for Transtibial Prosthetic Socket Fitting
Lead Sponsor:
University of Southampton
Collaborating Sponsors:
Radii Devices Ltd
Opcare Ltd
Conditions:
Transtibial Amputation
Prosthetic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Prosthetic socket comfort and fit is important in ensuring individuals with amputation can get the most use from their prosthetic limb. Researchers from the University of Southampton and a spin out co...
Detailed Description
A well-fitting, comfortable prosthetic socket is an urgent priority for the 170 million people worldwide with amputation as it stops people being able to achieve their goals and participate in society...
Eligibility Criteria
Inclusion
- aged 18 years or over
- Attend the Bristol, Oxford or Roehampton NHS Opcare prosthetic services
- Have had a transtibial amputation
- Deemed ready to cast for a new prosthesis by the clinical team as per usual care at the prosthetic centre
- Able to understand verbal and written English and provide informed consent
Exclusion
- under the age of 18
- Have had an ankle disarticulation, Knee disarticulation or transfemoral amputation
- Contraindication to be fit for a prosthetic socket
- Unwilling to trial or unable to tolerate trialling two sockets at a fitting session
- Unable to answer verbal questions (as per normal fitting appointment) on their socket fitting and comfort
Key Trial Info
Start Date :
October 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT06597266
Start Date
October 17 2022
End Date
November 30 2023
Last Update
September 23 2024
Active Locations (3)
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1
Bristol Centre for Enablement
Bristol, United Kingdom
2
Oxford Centre for Enablement
Oxford, United Kingdom
3
Douglas Bader Rehabilitation Centre, Queen Mary's Hospital
Roehampton, United Kingdom