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Bone-Anchored prosthesis could replace painful sockets for amputees

NCT ID NCT06737770

Disease control Sponsor: Istituto Ortopedico Rizzoli Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing an osteointegrated implant for people with leg amputations. Instead of a traditional socket that can cause skin problems, a metal stem is anchored directly to the bone. Researchers will measure quality of life and mobility in 15 participants to see if this approach is a better option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
osseointegrated surgery for transfemoral amputation
What this could lead to
If successful, this could provide a more comfortable and functional alternative to traditional socket prostheses for leg amputees.
What could go wrong
This is a small, early-stage study with only 15 participants, so results may not apply to everyone. The surgery carries risks like infection or implant failure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects of both sexes, aged between 18 and 65 years; * Subjects with unilateral transfemoral amputation, following trauma, tumor, infection, or congenital defect; * Subjects already scheduled for osteointegrated prosthesis surgery for amputation; * BMI \< 35 kg/m²; * Difficulty in using the traditional socket prosthesis (pain, reduced mobility, short residual limb, skin infections, ulcers, volume changes in the residual limb); * Subjects who have signed informed consent and reviewed the study information sheet. Absolute exclusion criteria: * Peripheral vascular diseases; * Pregnancy; * Rheumatoid arthritis; * Neurological deficits; * Amputation of the contralateral limb; * Active infections; * Immunodeficiency; * Comorbidities/concurrent disabilities, general or localized (Multiple Sclerosis, Parkinson's disease, muscle tone disorders, malignant neoplasms, etc.), that may interfere with the study; * Presence of uncontrolled psychiatric comorbidities; * Declared or evident cognitive deficits that would impair understanding of the tasks required (MMSE ≤ 24); * Insufficient degree of cooperation; * Length of the bone stump (measured from the lesser trochanter to the apex of the stump) less than 15 cm; * Previous radiotherapy on the amputated limb; * Ongoing chemotherapy treatments. Relative exclusion criteria: * Smoking; * Uncontrolled diabetes; * Previous infections; * Presence of additional joint prostheses on the same limb; * Osteoporosis with a T-score of -2.5 or lower.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amputation; traumatic, leg, lower Lower limb amputation knee Prosthesis

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • IRCCS Rizzoli Orthopedic Institute

    RECRUITING

    Bologna, 40136, Italy

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