Biomechanical Assessment of Load Applied on Residuum of Individuals With Limb Loss Fitted With a Prosthetic Limb

Amputation Clinical Trial

Official title:

Biomechanical Assessment of Load Applied on Residuum of Individuals With Limb Loss Fitted With a Prosthetic Limb

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05870267
• Other study ID #: 2021-YRP-LLA-Load-01
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: YourResearchProject Pty Ltd
• Contact: Lisa Tronicke, M.Sc.
• Phone: 15155367970
• Email: ltronicke[@]ossur.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Design 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).

Arms

The whole observational study will involve a total of 30 participants (20 prospective and 10 retrospective data sets) considered in the following fours arms:

• 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 microprocessor controlled knees (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.

• 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.

Only arms 1 to 3 will involve new recording of the loading profile as part of the prospective cross-sectional cohort study for a total of 20 participants. Arms 4 will constitute the retrospective part of the study.

The data collection in Arms 1 to 3 will be organised around:

• Sessions including back-to-back successive testing of participants over a few days.

• Testing including 24 tasks enabling the recording of all the data (e.g., kinetic, video, experience) for a participant fitted with three knees (e.g., Arm 1: Power Knee, Arm 2: Usual MPKs, Arm 3: Rheo Knee).

• Recording of the loading applied on implant of participants during five trials or more of standard daily activities.

Testing:

The forces and moments applied on the three axes of the residuum, commonly referred to as the "load", were measured directly using the load cell of the iPecsLab (RTC Inc, USA). The load cell will be fitted between the participant's connector attached to the percutaneous part of the osseointegrated implant and the prosthetic knee joint.

The maximum duration of the testing will be under 6:30 hrs including 3 hrs, 3 hrs and 5 hrs requiring active participation of YourResearchProject nominated representative, Certified Prosthetist Orthotist (CPO) at APC and participant for the cohort entered in Arms 1 and 2, respectively.

The maximum duration of the testing will be under 8 hrs including 4 hrs, 4 hrs and 6:40 hrs requiring active participation of YourResearchProject nominated representative, CPO at APC and participant for the cohort entered in Arm 3, respectively.

Participants A total of 30 individuals fitted with transfemoral bone anchored prosthesis (BAP) will be asked to participate in this study. Expecting 33% drop-out rate 20 participants are expected to provide data for analysis. 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).

A tentative list of inclusion and exclusion criteria is presented in Table 1. However, the final inclusion and exclusion criteria will be discussed with CPO at APC recruiting participants.

Priority will be given to individuals treated by the team at APC who are already familiar with and, possibly, current users of MPKs including Power Knee and/or Rheo Knee XC as well as Pro-Flex XC or LP feet.

No restrictions will be placed on the ethnicity or gender of potential participants.

Recruitment Potential participants will be identified by the APC. using an arm-length method of recruitment.

Prosthesis Components Participants will be fitted with an instrumented prosthesis made of load cell and state-of-the-art components including Power Knee (Arm 1), their usual MPK (Arm 2) or Rheo Knee XC (Arm 3) as well as nominated foot/ankle units (e.g., Pro-Flex XC or LP feet) and their own footwear.

Recording Timeline The 20 participants included in Arms 1 and 2 will be asked to perform recording with Power Knee and the usual MPKs. The 5 participants selected for Arm 3 will perform an additional testing with the Rheo Knee. Altogether, the study will require a total of 20 testing.

Activities The loads will be measured while participants performed five standardized daily activities consecutively including straight level walking, ascending and descending ramp and stairs.

The recording of the actual load applied on the fixation in each activity will take place in the nominated facility (e.g., APC in Alexandria).

In all cases, a high number of gait cycles will be recorded providing sufficient number of samples to warrant comprehensive analysis if needed (e.g., statistical power).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Amputation
• Prosthesis User

Intervention

Device:
• Power Knee with bone anchored suspension
Motor powered microprocessor controlled prosthetic knee joint
• C-Leg
Passive hydraulic microprocessor controlled prosthetic knee joint
• Rheo Knee XC
Passive magneto-rheologic microprocessor controlled knee joint

Locations

Country	Name	City	State
Australia	YourResearchProject Pty Ltd	Bardon	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
YourResearchProject Pty Ltd	Össur Ehf

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	The variability of datasets	The intra-variability of a dataset for a participant and inter-variability of a dataset between participants will be characterised by percentage of variation	24 months
Secondary	Factor of safety	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).	24 months
Secondary	Prosthesis efficacy	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.	24 months