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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05870267
Registration number
NCT05870267
Ethics application status
Date submitted
9/09/2021
Date registered
23/05/2023
Date last updated
8/02/2024
Titles & IDs
Public title
Biomechanical Assessment of Load Applied on Residuum of Individuals With Limb Loss Fitted With a Prosthetic Limb
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Scientific title
Biomechanical Assessment of Load Applied on Residuum of Individuals With Limb Loss Fitted With a Prosthetic Limb
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Secondary ID [1]
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2021-YRP-LLA-Load-01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prosthesis User
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Amputation
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Power Knee with bone anchored suspension
Treatment: Devices - C-Leg
Treatment: Devices - Rheo Knee XC
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.
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.
Treatment: Devices: Power Knee with bone anchored suspension
Motor powered microprocessor controlled prosthetic knee joint
Treatment: Devices: C-Leg
Passive hydraulic microprocessor controlled prosthetic knee joint
Treatment: Devices: Rheo Knee XC
Passive magneto-rheologic microprocessor controlled knee joint
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Cadence
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Assessment method [1]
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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.
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Timepoint [1]
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24 months
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Primary outcome [2]
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Magnitude of loading pattern
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Assessment method [2]
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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.
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Timepoint [2]
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24 months
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Primary outcome [3]
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Maximum moments in gait cycle
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Assessment method [3]
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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.
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Timepoint [3]
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24 months
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Secondary outcome [1]
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The variability of datasets
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Assessment method [1]
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The intra-variability of a dataset for a participant and inter-variability of a dataset between participants will be characterised by percentage of variation
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Timepoint [1]
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24 months
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Secondary outcome [2]
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Factor of safety
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Assessment method [2]
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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).
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Timepoint [2]
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24 months
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Secondary outcome [3]
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Prosthesis efficacy
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Assessment method [3]
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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.
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Timepoint [3]
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24 months
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Eligibility
Key inclusion criteria
- 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,
- 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.
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
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Key exclusion criteria
- 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,
- have major uncorrected visual deficit,
- have history of epilepsy or recurrent dizziness,
- present signs of infection 2 weeks prior testing session.
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Study design
Purpose
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Duration
Cross-sectional
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2024
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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YourResearchProject Pty Ltd - Bardon
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Recruitment postcode(s) [1]
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4065 - Bardon
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
YourResearchProject Pty Ltd
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Össur Ehf
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief 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. 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:
A. 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05870267
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Laurent Frossard, PhD
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Address
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YourResearchProject Pty Ltd
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Lisa Tronicke, M.Sc.
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Address
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Country
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Phone
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15155367970
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05870267
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