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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
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?
No
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
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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.
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.
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.
Available for what types of analyses?
How or where can data be obtained?


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