Osseointegrated Prostheses for Lower Limb Amputation
Instrumental Analysis of Walking in People With Osseointegrated Prostheses for Lower Extremity Amputation: Comparative Evaluation With Traditional Socket Prostheses
Recruiting
N/AInterventional Study
Lower Extremity Amputation
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
8 (estimated)
Sponsor
Istituto Auxologico Italiano · Other
Who this trial is looking for
This trial is looking for adults with a single lower limb amputation to compare two types of prostheses: traditional socket-mounted ones and new osseointegrated prostheses. Participants will help researchers understand how these different prostheses affect walking and balance.
Are You a Good Fit for This Trial?
You may be able to join if
I have a unilateral lower extremity amputation.
I am over 18 years old.
My Body Mass Index is between 18 and 25.
I can understand instructions.
I can sign the informed consent form.
You may not be able to join if
I have had other major knee injuries or surgeries on my lower limbs.
I have neurological conditions or vascular diseases.
I have cancer in the area that will be examined.
I have other neurological issues affecting my balance and walking.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The currently accepted standard for rehabilitation and mobility following amputation is a socket-mounted prosthesis. Osseointegration is an alternative method that has gradually gained greater acceptance in the last 30 years. It is defined as a procedure in which a metal implant is directly anchored to the residual bone, attached to a prosthetic limb using a transcutaneous connector.
The advantag…
The currently accepted standard for rehabilitation and mobility following amputation is a socket-mounted prosthesis. Osseointegration is an alternative method that has gradually gained greater acceptance in the last 30 years. It is defined as a procedure in which a metal implant is directly anchored to the residual bone, attached to a prosthetic limb using a transcutaneous connector.
The advantages of osseointegrated prostheses over conventional socket prostheses include stable fixation, significant increases in walking ability, range of motion and control of the prosthesis, and health-related quality of life. Moreover, bodyweight distribution results more similar to physiological conditions.
No formal consensus exists for osseointegration surgery. However, based on the positive clinical experience, surgeons currently indicate this surgery for those patients who show poor tolerance of socket prostheses.
The present study investigates neuro-physiologic and mechanical parameters of walking and balance in patients with lower limb amputation and osseointegrated prostheses and in matched patients with traditional socket prostheses to highlight strengths and weaknesses of the alternative technique with respect to the present standard of care.
The primary endpoint is the investigation of the neurologic and mechanic adaptation in terms of a) kinematic and dynamic segmental analysis of walking and transfer of the body center of mass during walking; b) capacity to retain balance in response to different conditions of oscillation, tilt, and translation of a posturographic platform.
The secondary endpoint is investigating of adaptation to walking on a split-belt treadmill mounted on force sensors with the belts running at different velocities.
We hypothesize that:
* the deficit in joint power of the prosthetic limb is associated with a phenomenon of "learned non-use" both in balance and during gait. This behavior looks automatic and unconscious. It consists of the under recruitment of the impaired side as a form of unconscious protection, which is adopted when the contralateral side may be exploited to carry out the function;
* the joint power provided by the prosthetic limb may increase both by increasing treadmill velocity and by walking in split-belt modality with the prosthetic limb on the faster belt;
* an "after-effect" will be evidenced after the split-belt walking test when the two belts will return to the same velocity; patients with osseointegrated prostheses and patients with socket prostheses may show different behaviors in the adaptation to split-belt walking and the following post-adaptation, as a result of the residual proprioception of the amputated limb.
Results from the present study will allow:
* the identification of the possible advantages in walking and balance symmetry in patients with osseointegrated prostheses with respect to patients with socket prostheses;
* the estimate of the sample size for future experimental protocols and new rehabilitative programs.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* unilateral lower extremity amputation;
* age \> 18 years;
* amputation-adjusted Body Mass Index between 18 and 25;
* ability to understand the instructions;
* ability to wittingly sign the informed consent form.
Exclusion Criteria:
* other previous knee injuries or major sur…
Inclusion Criteria:
* unilateral lower extremity amputation;
* age \> 18 years;
* amputation-adjusted Body Mass Index between 18 and 25;
* ability to understand the instructions;
* ability to wittingly sign the informed consent form.
Exclusion Criteria:
* other previous knee injuries or major surgical interventions at the lower limbs;
* comorbidities, such as neurological conditions, vascular diseases, or diseases of orthopedic, cardiac, or pulmonary origin;
* cancer disease in the site under examination;
* other neurological pathologies with impact on balance and gait.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.