Lower Limb Amputation Above Knee (Injury)NCT06017024
New Microprocessor-Controlled Prosthetic Knee Evaluation
A study of Lower Limb Amputation Above Knee (Injury), run by Proteor Group at 5 sites in France.
Trial summary
The target of this clinical investigation is to compare the achievement of personal functional goals using a new MPK and current MPK. Subjects will also run functional tests and questionnaires to compare performances and feedback with each prosthetic knee. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lower Limb Amputation Above Knee (Injury)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 5 sitesFrance
- Study dates
- 7 Jun 2023to 11 Dec 2024
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand and give informed consent
- Man or woman, more than 18 y.o
- Lower limb amputee KD or AKA, unilateral or bilateral
- K3/K4 activity level
- Already fitted with FR-reimbursed MPK
- Being comfortable in their socket (SCS>=5)
Who cannot join
- Protected person
- Pregnant or breast feeding lady
- Person having pathologies affecting their sensitivity
- Using walking aids
- Weighting more than 136kg
- Insufficient hip joint or pelvic voluntary muscle control
- Insufficient cognitive ability to charge the knee and care for the device
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hôpital Léon Bérard
Hyères
Clinique du Dr Ster
Lamalou-les-Bains
UGECAM Nord-Est IRR
Nancy
Centre Mutualiste de Kerpape
Ploemeur
UGECAM La Tourmaline
Saint-Herblain
About this study
Official title: Evaluation of a New Microprocessor-Controlled Prosthetic Knee : A Prospective, Multicentered, Randomized Cross-over Trial
The target of this clinical investigation is to compare the achievement of personal functional goals using a new MPK and current MPK. Subjects will also run functional tests and questionnaires to compare performances and feedback with each prosthetic knee.
- Being tested
- microprocessor-controlled knee (MPK) assessment
- Keywords
- Micro-processor controlled knee, Lower Limb prosthesis, Patient-specific Functional Scale
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microprocessor-controlled knee (MPK) assessmentDevice
The subject will wear the microprocessor-controlled knee prosthesis for 4 weeks, and then reply questionnaires and achieve functional tests
| Study group | Role | What they receive |
|---|---|---|
| Current microprocessor-controlled knee (MPK) then New MPK | Experimental | Start using current MPK for 4 weeks before fitting new MPK and use it for 4 weeks Receives: Device: microprocessor-controlled knee (MPK) assessment |
| New MPK then Current MPK | Experimental | Start using new MPK for 4 weeks before fitting back current MPK and use it for 4 weeks Receives: Device: microprocessor-controlled knee (MPK) assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal goal achievement
Patient-specific Functional Scale - PSFS - [0-10], the higher the better
Measured: test sessions 1 and 2 (20 minutes)
Secondary outcomes (8)
Functional walking test - mobility capacity
6-minute walk test (6MWT)
Measured: test sessions 1 and 2 (8 minutes)
Functional walking test - fast walking speed
10-meter walk test (10mWT)
Measured: test sessions 1 and 2 (1 minute)
Functional test - ability to walk downhill
Hill assessment index (HAI) [0-11], the higher the better
Measured: test sessions 1 and 2 (3 minutes)
Functional test - ability to walk downstairs
Stairs assessment index (SAI) [0-13], the higher the better
Measured: test sessions 1 and 2 (3 minutes)
Questionnaire to assess comfort in the socket
Socket comfort score (SCS) [0-10], the higher the better
Measured: test sessions 1 and 2 (1 minute)
Questionnaire to assess satisfaction
Quebec User Evaluation of Satisfaction with assistive Technology (QUEST = ESAT in French); the higher the better
Measured: test sessions 1 and 2 (5 minutes)
Questionnaires to assess quality of life
Short Form (36) health survey (SF-36); the higher the better
Measured: test sessions 1 and 2 (5 minutes)
Prosthesis Evaluation Questionnaire
PEQ, 8 sub-scales [0-100], the higher the better
Measured: test sessions 1 and 2 (29 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start7 Jun 2023
- Primary completion11 Dec 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Amputation Above Knee (Injury)Studies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proteor Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017024
- Sponsor's protocol ID
- 2022-A01266-37
- Status last verified
- Dec 2024
- First submitted
- 19 Jul 2023
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Microprocessor-Controlled Prosthetic Knee : A Prospective, Multicentered, Randomized Cross-over Trial
- ClinicalTrials.gov ID
- NCT06017024
- Acronym / sponsor ID
- 2022-A01266-37
- Keywords
- Micro-processor controlled knee, Lower Limb prosthesis, Patient-specific Functional Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Proteor GroupIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 30 Aug 2023 (actual)
- 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 target of this clinical investigation is to compare the achievement of personal functional goals using a new MPK and current MPK. Subjects will also run functional tests and questionnaires to compare performances and feedback with each prosthetic knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current microprocessor-controlled knee (MPK) then New MPK | Experimental | Device: microprocessor-controlled knee (MPK) assessmentStart using current MPK for 4 weeks before fitting new MPK and use it for 4 weeks |
| New MPK then Current MPK | Experimental | Device: microprocessor-controlled knee (MPK) assessmentStart using new MPK for 4 weeks before fitting back current MPK and use it for 4 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to understand and give informed consent
- Man or woman, more than 18 y.o
- Lower limb amputee KD or AKA, unilateral or bilateral
- K3/K4 activity level
- Already fitted with FR-reimbursed MPK
Key exclusion criteria (7 listed)
- Protected person
- Pregnant or breast feeding lady
- Person having pathologies affecting their sensitivity
- Using walking aids
- Weighting more than 136kg
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 |
|---|---|---|
| microprocessor-controlled knee (MPK) assessmentThe subject will wear the microprocessor-controlled knee prosthesis for 4 weeks, and then reply questionnaires and achieve functional tests | Device | Current microprocessor-controlled knee (MPK) then New MPK, New MPK then Current MPK |
Primary outcome
Personal goal achievement
Time frame: test sessions 1 and 2 (20 minutes)
Patient-specific Functional Scale - PSFS - [0-10], the higher the better
8 secondary outcomes
Functional walking test - mobility capacity
Time frame: test sessions 1 and 2 (8 minutes)
Functional walking test - fast walking speed
Time frame: test sessions 1 and 2 (1 minute)
Functional test - ability to walk downhill
Time frame: test sessions 1 and 2 (3 minutes)
Functional test - ability to walk downstairs
Time frame: test sessions 1 and 2 (3 minutes)
Questionnaire to assess comfort in the socket
Time frame: test sessions 1 and 2 (1 minute)
Questionnaire to assess satisfaction
Time frame: test sessions 1 and 2 (5 minutes)
Questionnaires to assess quality of life
Time frame: test sessions 1 and 2 (5 minutes)
Prosthesis Evaluation Questionnaire
Time frame: test sessions 1 and 2 (29 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Lower Limb Amputation Above Knee (Injury), run by Proteor Group at 5 sites in France.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal goal achievement (time frame: test sessions 1 and 2 (20 minutes)). 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 13 Dec 2024.