A Biomechanical Evaluation of the Ossur Power Knee in Persons With Transfemoral Amputation

Transfemoral Amputation Clinical Trial

— OPKTFA  

Official title:

Do Transfemoral Prostheses With Powered Prosthetic Knee Flexion and Extension Improve Mobility? A Biomechanical Evaluation of the Ossur Power Knee

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06218238
• Other study ID #: A4541-R
• Secondary ID: RX004541-01A2
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: March 31, 2027

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: Rebecca Stine, MS
• Phone: (312) 503-5726
• Email: rebecca.stine[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Microprocessor-controlled knees (MPKs) do not typically utilize motors to power joint rotation, but they automatically adjust resistance or damping in the joint to improve swing- and/or stance-phase control as appropriate for the prosthesis user during gait. The Ossur Power Knee is the only commercially-available MPK that uses a motor to provide active power generation during walking and other activities. The purpose of this proposed investigation is to perform and compare biomechanical evaluations of the Power Knee and Ossur Rheo XC, a passive MPK, during walking and other activities by prosthesis users. Furthermore, mobility between male and female subjects will be compared to determine if there are differences in prosthetic knee usage on the basis of sex.

Description:

The anatomical knee is a complex, polycentric joint characterized by a large range of motion in the sagittal plane and limited mobility in the coronal and transverse planes. The sagittal plane motion is used for progression in stance phase, and limb clearance and advancement in swing. Limb prostheses are intended to restore function and cosmesis in persons with limb loss. The complexity and function of prosthetic components have advanced significantly as technology has improved, but a state-of-the-art artificial limb is still a relatively poor substitute for an anatomical one. Microprocessor-controlled knees (MPKs) do not typically utilize motors to power joint rotation, but they automatically adjust resistance or damping in the joint to improve swing- and/or stance-phase control as appropriate for the user during gait. The Ossur Power Knee, which was first introduced in 2006, is the only MPK that uses a motor to provide active power generation during walking and other activities involving knee flexion and extension. Last year, Ossur released the 3rd generation of its Power Knee and appears to have addressed many of the previous shortcomings in terms of reduced weight, less noise, lower cost and longer battery life. Therefore, the newest version of the Power Knee warrants a fresh evaluation since it is, in essence, substantially different in design and function from previous models.

The purpose of this proposed investigation is to perform biomechanical evaluations of the new Ossur Power Knee during walking and other activities by transfemoral prosthesis users. Using a cross-over experimental design, approximately 20 unilateral, transfemoral amputee subjects (10 men and 10 women) will be evaluated in the Jesse Brown VAMC Motion Analysis Research Laboratory (MARL) while wearing the Ossur Power Knee and Ossur Rheo XC, which is a passive MPK device. Furthermore, the Ossur Power Knee may offer distinct advantages to female prosthesis users, so mobility will be compared between men and women to determine if differences exist on the basis of sex. The specific aims and hypotheses of this project are:

Aim 1: To compare the effects of the Ossur Power Knee and Ossur Rheo XC on the gait of unilateral, transfemoral prosthesis users during level walking. Kinematic and kinetic data will be collected as subjects walk in the MARL. Hypothesis--the active knee flexion and extension provided by the Ossur Power Knee will (1) improve walking performance, and (2) reduce metabolic energy cost during ambulation.

Aim 2: To compare the effects of the Ossur Power Knee and Ossur Rheo XC on stairs, slopes and during sit-to-stand/stand-to-sit activities of unilateral, transfemoral prosthesis users. Kinematic data will be collected as subjects perform these activities. Hypothesis--subjects will have improved performance when using the Ossur Power Knee.

Aim 3: To analyze and compare gender specific data between subjects using the Ossur Power Knee and the Ossur Rheo XC. Hypothesis--male and female subjects will demonstrate substantially different abilities to use the two knee components, indicating that gender specific components should be further investigated and developed. Research focusing on the unique prosthetic needs of women Veterans is currently a special emphasis area of the VA RR&D Service.

Subjects will also be administered questionnaires and provided at-home diaries to document their perceptions of comfort, exertion and stability while using the different prosthetic knee units.

The repeated-measures, cross-over protocol design enables each subject to serve as their own control, and it will be determined whether statistically significant changes occur in their performance measures. A two-way mixed-methods ANOVA will be used to assess the main and interaction effects of sex (male, female) and knee type (Ossur Power Knee, Rheo XC). As a conservative approach, a Bonferroni correction will be used to account for the family-wise Type I error rate because multiple outcomes will be used to address each hypothesis.

Increased understanding about how the Ossur Power Knee affects the abilities of transfemoral prosthesis users will facilitate appropriate component selection by prosthetists and ultimately improve quality of life for prosthesis users.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Unilateral, transfemoral amputation (any etiology).

• Age from 45-75 years.

• Residual limb length classified as standard (i.e., medium) to long.

• Prosthesis user for at least 1 year prior to enrolling in the study.

• K3 or K4 level ambulator.

• Good sensation on their residual limb(s) (upon routine clinical examination).

• Good skin integrity upon visual inspection.

• Does not require the use of assistive devices to walk for short distances.

• Not currently taking medications that are known to affect balance or gait.

• Presents with good socket fit based upon a standard assessment by the study prosthetist.

Exclusion Criteria:

• Bilateral amputations

• Individuals with a knee disarticulation

Related Conditions & MeSH terms

• Limb Loss
• Transfemoral Amputation

Intervention

Other:
• Powered prosthetic knee joint
Subjects will be fitted and trained on the Ossur Power Knee. An accommodation of 1 month will be provided prior to evaluation with the knee joint.
• Conventional prosthetic knee joint
Subjects will be fitted and trained on the Ossur Rheo XC Knee. An accommodation of 1 month will be provided prior to evaluation with the knee joint.

Locations

Country	Name	City	State
United States	Jesse Brown VA Medical Center, Chicago, IL	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking speed	Walking speed will be measured as participants walk on level ground at slow, normal and fast speeds.	To be measured after the 1-month accommodation period of wearing each prosthetic knee component
Primary	Metabolic energy cost	The metabolic energy rate will be measured as subjects walk at their freely selected speed on a level treadmill, which will be converted to metabolic energy cost (energy expended per unit distance).	To be measured after the 1-month accommodation period of wearing each prosthetic knee component
Primary	Sit-to-stand/stand-to-sit symmetry	Knee kinematics and load distribution between the sound and prosthetic sides will be measured as participants stand up and sit down in a chair.	To be measured after the 1-month accommodation period of wearing each prosthetic knee component
Secondary	Step length	The step lengths of the sound and prosthetic sides will be measured as participants walk on level ground at slow, normal and fast speeds.	To be measured after the 1-month accommodation period of wearing each prosthetic knee component
Secondary	Toe clearance during swing phase	Toe clearance during swing phase on the prosthetic side will be measured as participants walk on level ground at slow, normal and fast speeds.	To be measured after the 1-month accommodation period of wearing each prosthetic knee component
Secondary	Sound leg loading rate	The sound leg loading rate during walking will be measured as participants walk on level ground at slow, normal and fast speeds.	To be measured after the 1-month accommodation period of wearing each prosthetic knee component
Secondary	Kinematics of pelvic motion	Pelvic tilt, rotation and obliquity will be measured as participants walk on level ground at slow, normal and fast speeds.	To be measured after the 1-month accommodation period of wearing each prosthetic knee component