Status:
ACTIVE_NOT_RECRUITING
Acceptability of an Interim Socket System
Lead Sponsor:
University of Hull
Collaborating Sponsors:
Portsmouth Hospitals NHS Trust
University Hospitals Dorset NHS Foundation Trust
Conditions:
Amputation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will explore the acceptability of an interim socket system to new patients with a below-knee amputation and also to NHS healthcare providers.
Detailed Description
After a transtibial amputation, post-operative swelling, followed by muscle wasting, can lead to residual limb volume changes during the first 12 months. Managing this volume change often involves man...
Eligibility Criteria
Inclusion
- Over the age of 18
- New transtibial amputation within the last 6 months
- Deemed ready to cast for a prosthesis by the clinical team as per usual care at the prosthetic centre
- Able to understand written English and provide informed consent
Exclusion
- Participants under the age of 18
- Participants with an ankle disarticulation, Knee disarticulation or transfemoral amputation
- Body mass \> 125 kg with a distal circumference of 23-34 cm (small socket)
- Body mass \> 150 kg with a distal circumference of 30-45 cm (large socket)
- Residual limb longer than 27 cm
- Severe upper limb dysfunction (due to strength requirements to don the liner)
- Severe visual requirements (that would restrict the person's ability to monitor their residual limb)
- Contraindication to be fit for a prosthetic socket
- Recent cerebrovascular event (i.e., stroke, haemorrhage, brain injury)
- Disease affecting their memory
- Unwilling to trial the confidence socket system
- Unable to tolerate wearing a prosthetic liner due to excess sweating/ allergic reaction or other reasons
Key Trial Info
Start Date :
October 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 28 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05196100
Start Date
October 12 2021
End Date
November 28 2024
Last Update
September 27 2024
Active Locations (2)
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1
University Hospitals Dorset NHS Foundation Trust
Bournemouth, United Kingdom, BH7 7DW
2
Portsmouth Hospitals University NHS Trust
Portsmouth, United Kingdom, PO3 6AD