Prosthesis UserNCT05870267
Biomechanical Assessment of Load Applied on Residuum of Individuals With Limb Loss Fitted With a Prosthetic Limb
An observational study of Prosthesis User and Amputation, run by YourResearchProject Pty Ltd at 1 site in Australia.
Trial summary
This study will aim at performing biomechanical analyses of the actual load applied on the end of the stump (residuum) of individuals with transfemoral limb loss fitted with bionics bone-anchored prostheses during activities of daily living. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Prosthesis User, Amputation
- What is being tested?
- Power Knee with bone anchored suspension, C-Leg and Rheo Knee XC
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Oct 2021to Jun 2024
- Phase
- Observational
- 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 80 years
- All sexes
- Adult, Older adult
Study population: A total of 30 individuals fitted with transfemoral BAP will be asked to participate in this study. Drop-out rate is estimated at 33%, resulting in 20 participants completing the study. All participants will be asked to enter Arms 1 and 2 of the study (N=20). Five of these participants will be asked to enter Arm 3 of the study (N=5).
Who may be able to join
- be willing to participate to this project of research,
- be able to be fitted with common bionic prosthetic components (e.g., Knee, feet),
- be willing to comply with protocol,
- have a lower limb amputation more than 12 months prior testing,
- have a clearance of at least 6 cm between residuum and prosthetic joint,
- have completed rehabilitation program,
Show all 10Show fewer
- be free of injuries on the day of the recording session,
- weigh less than 121 kg,
- be able to walk 200 meters independently,
- be between 18-80 years of age.
Who cannot join
- not be able to give informed consent,
- have bilateral amputation,
- have self-reported pain levels greater than 4 out of 10 at study outset,
- have experienced a fall within the last 8 weeks before assessment,
- have mental illness or intellectual impairment,
- have injuries involving contralateral (intact) limb,
Show all 9Show fewer
- have major uncorrected visual deficit,
- have history of epilepsy or recurrent dizziness,
- present signs of infection 2 weeks prior testing session.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
YourResearchProject Pty Ltd
Bardon, Queensland, 4065
Laurent Frossard, PhD, 0413795086 ext. +61, laurentfrossard@outlook.com
About this study
This study will aim at performing biomechanical analyses of the actual load applied on the end of the stump (residuum) of individuals with transfemoral limb loss fitted with bionics bone-anchored prostheses during activities of daily living. The assessment of the inner prosthetic loading will rely on the analyses of common activities of daily living (e.g., walking in straight line and around circles, ascending and descending stairs and slopes, cycling, etc.) performed in experimental and/or clinical and/or open environments.
The biomechanical analyses of the load will address the following research questions:
Read more
- What is the actual magnitude of the forces and moments applied on transfemoral osseointegrated implant by Rheo Knee and Power Knee during activities of daily living? living? B. What are the determinants of the loading profile in relation to the demographic and anthropometric characteristics, the type and level of activities as well as type, fitting and alignment of Rheo Knee and Power Knee? C. How the loading profiles applied by Rheo Knee and Power Knee compared to usual MPKs and Non-MPK considered below standard of care?
Biomechanical data will be collected through a typical cross-sectional cohort study. Each participant will be assessed with a given prosthesis at one particular time (i.e., exposure and outcomes will be both measured at the same time). These biomechanical analyses will rely on already published protocols (e.g., study design, instrumentation setup, extraction of loading profile). Protocols to record load data have been well described by PI-Frossard in over 20 peer-review publications in top-ranked journals. The protocol used in this study has been acknowledged, validated and are commonly used within the fields of biomechanics and prosthetics.
The outcome of this study will increase the basic understanding about the effects of loading on the interaction between body and prosthesis (e.g., osseointegration between residual bone and implant). The study will also increase applied knowledge required to establish stronger evidence-based rehabilitation programs, fitting of prosthetic limbs and design of bionics prosthetic components.
It is anticipated that, both basic and applied knowledge gain in this study will, all together, contribute to increase the health-related quality of life of individuals fitted with socket and bone-anchored prostheses.
Read the detailed description
Design Biomechanical data will be collected through a typical cross-sectional cohort study. Each participant will be assessed with a given prosthesis at one particular time (i.e., exposure and outcomes will be both measured at the same time).
Arms
The whole observational study will involve a total of 30 participants (20 prospective and 10 retrospective data sets) considered in the following fours arms:
- Arm 1 will be designed as observational study providing the efficacy and safety of the load applied on osseointegrated fixation by transfemoral BAP fitted with the Power Knee for the whole cohort of 20 participants.
- Arm 2 will be designed as matched case-control study comparing the efficacy and safety the load applied on osseointegrated fixation by transfemoral BAP fitted with Power Knee and usual microprocessor controlled knees (MPKs) (e.g., C-Leg, Genium) for the whole cohort of 20 participants.
- Arm 3 will be designed as matched case-control study comparing the efficacy and safety the load applied on osseointegrated fixation by transfemoral BAP fitted with Power Knee and Rheo Knee XC for a subgroup of 5 participants.
- Arm 4 will be designed as matched case-control study comparing the efficacy and safety the load applied on osseointegrated fixation by transfemoral BAP fitted with Power Knee for the whole cohort of 20 participants and non-MPKs for another cohort of 10 participants.
Only arms 1 to 3 will involve new recording of the loading profile as part of the prospective cross-sectional cohort study for a total of 20 participants. Arms 4 will constitute the retrospective part of the study.
The data collection in Arms 1 to 3 will be organised around:
- Sessions including back-to-back successive testing of participants over a few days.
- Testing including 24 tasks enabling the recording of all the data (e.g., kinetic, video, experience) for a participant fitted with three knees (e.g., Arm 1: Power Knee, Arm 2: Usual MPKs, Arm 3: Rheo Knee).
- Recording of the loading applied on implant of participants during five trials or more of standard daily activities.
Testing:
The forces and moments applied on the three axes of the residuum, commonly referred to as the "load", were measured directly using the load cell of the iPecsLab (RTC Inc, USA). The load cell will be fitted between the participant's connector attached to the percutaneous part of the osseointegrated implant and the prosthetic knee joint.
The maximum duration of the testing will be under 6:30 hrs including 3 hrs, 3 hrs and 5 hrs requiring active participation of YourResearchProject nominated representative, Certified Prosthetist Orthotist (CPO) at APC and participant for the cohort entered in Arms 1 and 2, respectively.
The maximum duration of the testing will be under 8 hrs including 4 hrs, 4 hrs and 6:40 hrs requiring active participation of YourResearchProject nominated representative, CPO at APC and participant for the cohort entered in Arm 3, respectively.
Participants A total of 30 individuals fitted with transfemoral bone anchored prosthesis (BAP) will be asked to participate in this study. Expecting 33% drop-out rate 20 participants are expected to provide data for analysis. All participants will be asked to enter Arms 1 and 2 of the study (N=20). Five of these participants will be asked to enter Arm 3 of the study (N=5).
A tentative list of inclusion and exclusion criteria is presented in Table 1. However, the final inclusion and exclusion criteria will be discussed with CPO at APC recruiting participants.
Priority will be given to individuals treated by the team at APC who are already familiar with and, possibly, current users of MPKs including Power Knee and/or Rheo Knee XC as well as Pro-Flex XC or LP feet.
No restrictions will be placed on the ethnicity or gender of potential participants.
Recruitment Potential participants will be identified by the APC. using an arm-length method of recruitment.
Prosthesis Components Participants will be fitted with an instrumented prosthesis made of load cell and state-of-the-art components including Power Knee (Arm 1), their usual MPK (Arm 2) or Rheo Knee XC (Arm 3) as well as nominated foot/ankle units (e.g., Pro-Flex XC or LP feet) and their own footwear.
Recording Timeline The 20 participants included in Arms 1 and 2 will be asked to perform recording with Power Knee and the usual MPKs. The 5 participants selected for Arm 3 will perform an additional testing with the Rheo Knee. Altogether, the study will require a total of 20 testing.
Activities The loads will be measured while participants performed five standardized daily activities consecutively including straight level walking, ascending and descending ramp and stairs.
The recording of the actual load applied on the fixation in each activity will take place in the nominated facility (e.g., APC in Alexandria).
In all cases, a high number of gait cycles will be recorded providing sufficient number of samples to warrant comprehensive analysis if needed (e.g., statistical power).
- Conditions
- Prosthesis User, Amputation
- Being tested
- Power Knee with bone anchored suspension, C-Leg, Rheo Knee XC
- Keywords
- Artificial Limbs, Bone-anchored prosthesis, Bionics, Kinetics, Loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power Knee with bone anchored suspensionDevice
Motor powered microprocessor controlled prosthetic knee joint
C-LegDevice
Passive hydraulic microprocessor controlled prosthetic knee joint
Rheo Knee XCDevice
Passive magneto-rheologic microprocessor controlled knee joint
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (arms 1-3) | * Arm 1 will be designed as observational study providing the efficacy and safety of the load applied on osseointegrated fixation by transfemoral BAP fitted with the Power Knee for the whole cohort of 20 participants.
* Arm 2 will be designed as matched case-control study comparing the efficacy and safety the load applied on osseointegrated fixation by transfemoral BAP fitted with Power Knee and usual MPKs (e.g., C-Leg, Genium) for the whole cohort of 20 participants.
* Arm 3 will be designed as matched case-control study comparing the efficacy and safety the load applied on osseointegrated fixation by transfemoral BAP fitted with Power Knee and Rheo Knee XC for a subgroup of 5 participants. Receives: Device: Power Knee with bone anchored suspension; Device: C-Leg; Device: Rheo Knee XC | |
| Cohort 2 (arm 4) | • Arm 4 will be designed as matched case-control study comparing the efficacy and safety the load applied on osseointegrated fixation by transfemoral BAP fitted with Power Knee for the whole cohort of 20 participants and non-MPKs for another cohort of 10 participants. Receives: Device: Power Knee with bone anchored suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cadence
Strides per minute (stride/min) corresponding to the duration between two consecutive heel contacts of the prosthetic limb measured by the load cell as described above.
Measured: 24 months
Magnitude of loading pattern
Loading extrema correspond to onset and magnitude of a point of inflection of the loading pattern of three components of force and moment occurring consistently over successive steps, measured by the load cell as described above.
Measured: 24 months
Maximum moments in gait cycle
Loading boundaries corresponds to the minimum, maximum and absolute maximum of the three components of forces and moments across gait cycles in relevant segment regardless of the onset, respectively, measured by the load cell as described above.
Measured: 24 months
Secondary outcomes (3)
The variability of datasets
The intra-variability of a dataset for a participant and inter-variability of a dataset between participants will be characterised by percentage of variation
Measured: 24 months
Factor of safety
Safety of a prosthesis represented by the factor of safety ((FoS = [High impact load expressed in %BW / absolute maximum load expressed in %BW measured across all activities])) and margin of safety (MoS=FoS-1).
MoS is calculated considering loading data for similar activities as Arms 1, 2 and 3 from the literature (e.g., Taylor et al, 2001), challenging (Edward et al, 2008) and catastrophic conditions (Ivarsson et al, 2009).
Measured: 24 months
Prosthesis efficacy
Efficacy of a prosthesis defined as the capacity to achieve bodyweight acceptance on vertical axis that is within ±10% of full bodyweight as well as attenuate impact loads on the other axes and generate propel loads, measured by the load cell as described above.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start1 Oct 2021
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthesis UserStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YourResearchProject Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Össur Iceland ehf
- Responsible party
- Sponsor
- Investigators
- Laurent Frossard, PhD, Principal investigator, YourResearchProject Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870267
- Sponsor's protocol ID
- 2021-YRP-LLA-Load-01
- Status last verified
- Feb 2024
- First submitted
- 9 Sep 2021
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Plans for return of results of research to participants: Feedback will be provided to individual participants about their results upon request or in cases where they could possibly benefit medically or otherwise from information collected during the study. Participants will have the options to receive their own results and the overall results of the research. Publication plan Scientific results will be produced through typical publication outlets (e.g., books, book chapters, manuscripts, abstract, etc.) and made available from free-access depositories (e.g., ePrint, ResearchGate) where appropriate. Other potential uses of the data at the end of the project The broad dissemination of the outputs will be achieved through a range of mediums including individual reports, newsletters, websites detailing the research activities, annual reports and the information sessions to be held at national and international meetings.
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Assessment of Load Applied on Residuum of Individuals With Limb Loss Fitted With a Prosthetic Limb
- ClinicalTrials.gov ID
- NCT05870267
- Acronym / sponsor ID
- 2021-YRP-LLA-Load-01
- Conditions
- Prosthesis User, Amputation
- Keywords
- Artificial Limbs, Bone-anchored prosthesis, Bionics, Kinetics, Loading
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- YourResearchProject Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Össur Iceland ehf
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 23 May 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.
This study will aim at performing biomechanical analyses of the actual load applied on the end of the stump (residuum) of individuals with transfemoral limb loss fitted with bionics bone-anchored prostheses during activities of daily living. The assessment of the inner prosthetic loading will rely on the analyses of common activities of daily living (e.g., walking in straight line and around circles, ascending and descending stairs and slopes, cycling, etc.) performed in experimental and/or clinical and/or open environments.
The biomechanical analyses of the load will address the following research questions:
- What is the actual magnitude of the forces and moments applied on transfemoral osseointegrated implant by Rheo Knee and Power Knee during activities of daily living? living? B. What are the determinants of the loading profile in relation to the demographic and anthropometric characteristics, the type and level of activities as well as type, fitting and alignment of Rheo Knee and Power Knee? C. How the loading profiles applied by Rheo Knee and Power Knee compared to usual MPKs and Non-MPK considered below standard of care?
Biomechanical data will be collected through a typical cross-sectional cohort study. Each participant will be assessed with a given prosthesis at one particular time (i.e., exposure and outcomes will be both measured at the same time). These biomechanical analyses will rely on already published protocols (e.g., study design, instrumentation setup, extraction of loading profile). Protocols to record load data have been well described by PI-Frossard in over 20 peer-review publications in top-ranked journals. The protocol used in this study has been acknowledged, validated and are commonly used within the fields of biomechanics and prosthetics.
The outcome of this study will increase the basic understanding about the effects of loading on the interaction between body and prosthesis (e.g., osseointegration between residual bone and implant). The study will also increase applied knowledge required to establish stronger evidence-based rehabilitation programs, fitting of prosthetic limbs and design of bionics prosthetic components.
It is anticipated that, both basic and applied knowledge gain in this study will, all together, contribute to increase the health-related quality of life of individuals fitted with socket and bone-anchored prostheses.
Detailed description
Design Biomechanical data will be collected through a typical cross-sectional cohort study. Each participant will be assessed with a given prosthesis at one particular time (i.e., exposure and outcomes will be both measured at the same time).
Arms
The whole observational study will involve a total of 30 participants (20 prospective and 10 retrospective data sets) considered in the following fours arms:
- Arm 1 will be designed as observational study providing the efficacy and safety of the load applied on osseointegrated fixation by transfemoral BAP fitted with the Power Knee for the whole cohort of 20 participants.
- Arm 2 will be designed as matched case-control study comparing the efficacy and safety the load applied on osseointegrated fixation by transfemoral BAP fitted with Power Knee and usual microprocessor controlled knees (MPKs) (e.g., C-Leg, Genium) for the whole cohort of 20 participants.
- Arm 3 will be designed as matched case-control study comparing the efficacy and safety the load applied on osseointegrated fixation by transfemoral BAP fitted with Power Knee and Rheo Knee XC for a subgroup of 5 participants.
- Arm 4 will be designed as matched case-control study comparing the efficacy and safety the load applied on osseointegrated fixation by transfemoral BAP fitted with Power Knee for the whole cohort of 20 participants and non-MPKs for another cohort of 10 participants.
Only arms 1 to 3 will involve new recording of the loading profile as part of the prospective cross-sectional cohort study for a total of 20 participants. Arms 4 will constitute the retrospective part of the study.
The data collection in Arms 1 to 3 will be organised around:
- Sessions including back-to-back successive testing of participants over a few days.
- Testing including 24 tasks enabling the recording of all the data (e.g., kinetic, video, experience) for a participant fitted with three knees (e.g., Arm 1: Power Knee, Arm 2: Usual MPKs, Arm 3: Rheo Knee).
- Recording of the loading applied on implant of participants during five trials or more of standard daily activities.
Testing:
The forces and moments applied on the three axes of the residuum, commonly referred to as the "load", were measured directly using the load cell of the iPecsLab (RTC Inc, USA). The load cell will be fitted between the participant's connector attached to the percutaneous part of the osseointegrated implant and the prosthetic knee joint.
The maximum duration of the testing will be under 6:30 hrs including 3 hrs, 3 hrs and 5 hrs requiring active participation of YourResearchProject nominated representative, Certified Prosthetist Orthotist (CPO) at APC and participant for the cohort entered in Arms 1 and 2, respectively.
The maximum duration of the testing will be under 8 hrs including 4 hrs, 4 hrs and 6:40 hrs requiring active participation of YourResearchProject nominated representative, CPO at APC and participant for the cohort entered in Arm 3, respectively.
Participants A total of 30 individuals fitted with transfemoral bone anchored prosthesis (BAP) will be asked to participate in this study. Expecting 33% drop-out rate 20 participants are expected to provide data for analysis. All participants will be asked to enter Arms 1 and 2 of the study (N=20). Five of these participants will be asked to enter Arm 3 of the study (N=5).
A tentative list of inclusion and exclusion criteria is presented in Table 1. However, the final inclusion and exclusion criteria will be discussed with CPO at APC recruiting participants.
Priority will be given to individuals treated by the team at APC who are already familiar with and, possibly, current users of MPKs including Power Knee and/or Rheo Knee XC as well as Pro-Flex XC or LP feet.
No restrictions will be placed on the ethnicity or gender of potential participants.
Recruitment Potential participants will be identified by the APC. using an arm-length method of recruitment.
Prosthesis Components Participants will be fitted with an instrumented prosthesis made of load cell and state-of-the-art components including Power Knee (Arm 1), their usual MPK (Arm 2) or Rheo Knee XC (Arm 3) as well as nominated foot/ankle units (e.g., Pro-Flex XC or LP feet) and their own footwear.
Recording Timeline The 20 participants included in Arms 1 and 2 will be asked to perform recording with Power Knee and the usual MPKs. The 5 participants selected for Arm 3 will perform an additional testing with the Rheo Knee. Altogether, the study will require a total of 20 testing.
Activities The loads will be measured while participants performed five standardized daily activities consecutively including straight level walking, ascending and descending ramp and stairs.
The recording of the actual load applied on the fixation in each activity will take place in the nominated facility (e.g., APC in Alexandria).
In all cases, a high number of gait cycles will be recorded providing sufficient number of samples to warrant comprehensive analysis if needed (e.g., statistical power).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 (arms 1-3) | – | Device: Power Knee with bone anchored suspension, Device: C-Leg, Device: Rheo Knee XC* Arm 1 will be designed as observational study providing the efficacy and safety of the load applied on osseointegrated fixation by transfemoral BAP fitted with the Power Knee for the whole cohort of 20 participants. * Arm 2 will be designed as matched case-control study comparing the efficacy and safety the load applied on osseointegrated fixation by transfemoral BAP fitted with Power Knee and usual MPKs (e.g., C-Leg, Genium) for the whole cohort of 20 participants. * Arm 3 will be designed as matched case-control study comparing the efficacy and safety the load applied on osseointegrated fixation by transfemoral BAP fitted with Power Knee and Rheo Knee XC for a subgroup of 5 participants. |
| Cohort 2 (arm 4) | – | Device: Power Knee with bone anchored suspension• Arm 4 will be designed as matched case-control study comparing the efficacy and safety the load applied on osseointegrated fixation by transfemoral BAP fitted with Power Knee for the whole cohort of 20 participants and non-MPKs for another cohort of 10 participants. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A total of 30 individuals fitted with transfemoral BAP will be asked to participate in this study. Drop-out rate is estimated at 33%, resulting in 20 participants completing the study. All participants will be asked to enter Arms 1 and 2 of the study (N=20). Five of these participants will be asked to enter Arm 3 of the study (N=5).
Key inclusion criteria (10 listed)
- be willing to participate to this project of research,
- be able to be fitted with common bionic prosthetic components (e.g., Knee, feet),
- be willing to comply with protocol,
- have a lower limb amputation more than 12 months prior testing,
- have a clearance of at least 6 cm between residuum and prosthetic joint,
Key exclusion criteria (9 listed)
- not be able to give informed consent,
- have bilateral amputation,
- have self-reported pain levels greater than 4 out of 10 at study outset,
- have experienced a fall within the last 8 weeks before assessment,
- have mental illness or intellectual impairment,
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 |
|---|---|---|
| Power Knee with bone anchored suspensionMotor powered microprocessor controlled prosthetic knee joint | Device | Cohort 1 (arms 1-3), Cohort 2 (arm 4) |
| C-LegPassive hydraulic microprocessor controlled prosthetic knee joint | Device | Cohort 1 (arms 1-3) |
| Rheo Knee XCPassive magneto-rheologic microprocessor controlled knee joint | Device | Cohort 1 (arms 1-3) |
Primary outcome
Cadence
Time frame: 24 months
Strides per minute (stride/min) corresponding to the duration between two consecutive heel contacts of the prosthetic limb measured by the load cell as described above.
Magnitude of loading pattern
Time frame: 24 months
Loading extrema correspond to onset and magnitude of a point of inflection of the loading pattern of three components of force and moment occurring consistently over successive steps, measured by the load cell as described above.
Maximum moments in gait cycle
Time frame: 24 months
Loading boundaries corresponds to the minimum, maximum and absolute maximum of the three components of forces and moments across gait cycles in relevant segment regardless of the onset, respectively, measured by the load cell as described above.
3 secondary outcomes
The variability of datasets
Time frame: 24 months
Factor of safety
Time frame: 24 months
Prosthesis efficacy
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: Yes. Plans for return of results of research to participants: Feedback will be provided to individual participants about their results upon request or in cases where they could possibly benefit medically or otherwise from information collected during the study. Participants will have the options to receive their own results and the overall results of the research. Publication plan Scientific results will be produced through typical publication outlets (e.g., books, book chapters, manuscripts, abstract, etc.) and made available from free-access depositories (e.g., ePrint, ResearchGate) where appropriate. Other potential uses of the data at the end of the project The broad dissemination of the outputs will be achieved through a range of mediums including individual reports, newsletters, websites detailing the research activities, annual reports and the information sessions to be held at national and international meetings.
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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.
Laurent Frossard, PhD principal investigator
YourResearchProject Pty Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prosthesis User and Amputation, run by YourResearchProject Pty Ltd at 1 site in Australia.
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 10 inclusion and 9 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 8 Feb 2024. 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 Australia. 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 Lisa Tronicke, M.Sc. (15155367970 ext. +49, ltronicke@ossur.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cadence (time frame: 24 months). The study lists 3 primary outcomes in all. 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 8 Feb 2024.