Biomechanical Assessment of Load Applied on Residuum of Individuals With Limb Loss Fitted With a Prosthetic Limb
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedFirst Posted
Study publicly available on registry
May 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedFebruary 8, 2024
February 1, 2024
2.7 years
September 9, 2021
February 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
24 months
Secondary Outcomes (3)
The variability of datasets
24 months
Factor of safety
24 months
Prosthesis efficacy
24 months
Study Arms (2)
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.
Interventions
Motor powered microprocessor controlled prosthetic knee joint
Eligibility Criteria
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).
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- YourResearchProject Pty Ltdlead
- Össur Iceland ehfcollaborator
Study Sites (1)
YourResearchProject Pty Ltd
Bardon, Queensland, 4065, Australia
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent Frossard, PhD
YourResearchProject Pty Ltd
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2021
First Posted
May 23, 2023
Study Start
October 1, 2021
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
February 8, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 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.
- Access Criteria
- 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.
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.