Transfemoral AmputeesNCT01982721
Evaluation of an Acceleration-Based Prosthetic Knee Locking Mechanism for Reducing the Risk of Falling in Transfemoral Amputees
A study testing Locking mechanism for prosthetic knee in people with Transfemoral Amputees, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The investigators hypothesize that a new automatic prosthetic knee locking mechanism will improve gait characteristics during an induced controlled trip and reduce fear of falling. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Transfemoral Amputees
- What is being tested?
- Locking mechanism for prosthetic knee
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Nov 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- transfemoral amputees
- Independent ambulation with a prosthesis
- Full cognitive and cooperative ability to follow simple instructions
- No orthopaedic or neurologic impairments present, that are unrelated to the amputation at the time of the trial
Who cannot join
- Cognitive disorders preventing the subject from understanding the trial protocol, signing a consent form or following the researcher's instructions
- Orthopaedic or neurologic impairment, un-related to the amputation
- Pregnant woman
- Weight exceeding 100 kg
Trial locations and contacts
1 site in 1 country.
Isabela Schwartz, MD contact
Israel1 site
Hadassah Medical Organization
Jerusalem
Arik Tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
The investigators hypothesize that a new automatic prosthetic knee locking mechanism will improve gait characteristics during an induced controlled trip and reduce fear of falling.
- Conditions
- Transfemoral Amputees
- Being tested
- Locking mechanism for prosthetic knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Locking mechanism for prosthetic kneeDevice
| Study group | Role | What they receive |
|---|---|---|
| Transfemoral amputees | Experimental | Locking mechanism for prosthetic knee (no trade mark provided) Receives: Device: Locking mechanism for prosthetic knee |
| Healthy volunteers | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
3D angles of the ankle, knee, hip and pelvis
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startNov 2014
- Primary completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfemoral AmputeesStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Sigal Portnoy
- Responsible party
- Principal investigator, Isabella Shvartz, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982721
- Sponsor's protocol ID
- Roee_HMO-CTIL
- Status last verified
- Mar 2016
- First submitted
- 30 Oct 2013
- Last updated
- 31 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Acceleration-Based Prosthetic Knee Locking Mechanism for Reducing the Risk of Falling in Transfemoral Amputees
- ClinicalTrials.gov ID
- NCT01982721
- Acronym / sponsor ID
- Roee_HMO-CTIL
- Conditions
- Transfemoral Amputees
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- Dr. Sigal Portnoy
- Study start
- Nov 2014
- Primary completion
- Oct 2016 (estimated)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that a new automatic prosthetic knee locking mechanism will improve gait characteristics during an induced controlled trip and reduce fear of falling.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transfemoral amputees | Experimental | Device: Locking mechanism for prosthetic kneeLocking mechanism for prosthetic knee (no trade mark provided) |
| Healthy volunteers | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- transfemoral amputees
- Independent ambulation with a prosthesis
- Full cognitive and cooperative ability to follow simple instructions
- No orthopaedic or neurologic impairments present, that are unrelated to the amputation at the time of the trial
Key exclusion criteria (4 listed)
- Cognitive disorders preventing the subject from understanding the trial protocol, signing a consent form or following the researcher's instructions
- Orthopaedic or neurologic impairment, un-related to the amputation
- Pregnant woman
- Weight exceeding 100 kg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Locking mechanism for prosthetic knee | Device | Transfemoral amputees |
Primary outcome
3D angles of the ankle, knee, hip and pelvis
Time frame: One day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabela Schwartz, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Locking mechanism for prosthetic knee in people with Transfemoral Amputees, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabela Schwartz, MD (IsabellaS@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3D angles of the ankle, knee, hip and pelvis (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016; AzTrials last refreshed its copy on 6 Nov 2026.