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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
Scientific title
Biomechanical Assessment of Load Applied on Residuum of Individuals With Limb Loss Fitted With a Prosthetic Limb
Secondary ID [1] 0 0
2021-YRP-LLA-Load-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prosthesis User 0 0
Amputation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cadence
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
Magnitude of loading pattern
Timepoint [2] 0 0
24 months
Primary outcome [3] 0 0
Maximum moments in gait cycle
Timepoint [3] 0 0
24 months
Secondary outcome [1] 0 0
The variability of datasets
Timepoint [1] 0 0
24 months
Secondary outcome [2] 0 0
Factor of safety
Timepoint [2] 0 0
24 months
Secondary outcome [3] 0 0
Prosthesis efficacy
Timepoint [3] 0 0
24 months

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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
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.

Study design
Purpose
Duration
Cross-sectional
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
YourResearchProject Pty Ltd - Bardon
Recruitment postcode(s) [1] 0 0
4065 - Bardon

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
YourResearchProject Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Össur Ehf
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05870267
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Laurent Frossard, PhD
Address 0 0
YourResearchProject Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lisa Tronicke, M.Sc.
Address 0 0
Country 0 0
Phone 0 0
15155367970
Fax 0 0
Email 0 0
ltronicke@ossur.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05870267