New implantable leg prosthesis aims to end socket pain for amputees
NCT ID NCT03445481
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This pilot study tested a new type of leg prosthesis that is implanted into the bone, instead of using a socket that fits over the stump. It was for people with above-knee amputation who had pain or discomfort with their current socket prosthesis. The study was small (3 participants) and focused on quality of life and safety, but it was terminated early.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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3 people
The number who actually took part.
- Started
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Feb 2018
- Finished
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Sep 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age \>18 and \<75 years * Patients with Trans-femoral Amputations since at least 2 years and suffering from pain and discomfort with the current standard socket prosthesis, i.e., with a baseline VAS score for pain between 3 and 10 or a health-related quality of life (Eq-5D) score \< 60 or an SF-36 result below the 50th percentile * Amputation due to: 1. Trauma 2. Oncologic disease * Written informed consent Exclusion Criteria: * Trans-femoral amputation due to infection * Patients affected by 1. metabolic disease 2. neurologic degenerative disease 3. vascular disease proximal to the amputation 4. body weight \>100 kg 5. Hip arthritis of the amputated limb
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ospedale Regionale di Lugano Civico e Italiano
Lugano, 6900, Switzerland