Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05870267
Registration number
NCT05870267
Ethics application status
Date submitted
9/09/2021
Date registered
23/05/2023
Titles & IDs
Public title
Biomechanical Assessment of Load Applied on Residuum of Individuals With Limb Loss Fitted With a Prosthetic Limb
Query!
Scientific title
Biomechanical Assessment of Load Applied on Residuum of Individuals With Limb Loss Fitted With a Prosthetic Limb
Query!
Secondary ID [1]
0
0
2021-YRP-LLA-Load-01
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Prosthesis User
0
0
Query!
Amputation
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Cadence
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
24 months
Query!
Primary outcome [2]
0
0
Magnitude of loading pattern
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
24 months
Query!
Primary outcome [3]
0
0
Maximum moments in gait cycle
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
24 months
Query!
Secondary outcome [1]
0
0
The variability of datasets
Query!
Assessment method [1]
0
0
The intra-variability of a dataset for a participant and inter-variability of a dataset between participants will be characterised by percentage of variation
Query!
Timepoint [1]
0
0
24 months
Query!
Secondary outcome [2]
0
0
Factor of safety
Query!
Assessment method [2]
0
0
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).
Query!
Timepoint [2]
0
0
24 months
Query!
Secondary outcome [3]
0
0
Prosthesis efficacy
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
24 months
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/10/2021
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/06/2024
Query!
Actual
Query!
Sample size
Target
20
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
QLD
Query!
Recruitment hospital [1]
0
0
YourResearchProject Pty Ltd - Bardon
Query!
Recruitment postcode(s) [1]
0
0
4065 - Bardon
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
YourResearchProject Pty Ltd
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
Össur Ehf
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05870267
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Laurent Frossard, PhD
Query!
Address
0
0
YourResearchProject Pty Ltd
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Lisa Tronicke, M.Sc.
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
15155367970
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
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.
Query!
When will data be available (start and end dates)?
Project closure processes Retention or disposal of the documents or data will be in accordance with the Queensland State Archive University Sector Retention and Disposal Schedule for research data.
Query!
Available to whom?
Where possible, an open access approach to sharing de-identified data will be taken. At the conclusion of the project, all data will be deposited in an appropriate data repository and where appropriate non-identifiable data will be made accessible with permission.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05870267