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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Transfemoral Amputation; Limb Loss; Limb Absence
• Intervention / Treatment: Other: Powered prosthetic knee joint; Other: Conventional prosthetic knee joint

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Stine, MS; Phone Number: (312) 503-5726; Email: rebecca.stine@va.gov
• Study Contact Backup: Name: Steven A Gard, PhD; Phone Number: (312) 238-6525; Email: steven.gard@va.gov

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Jesse Brown VA Medical Center, Chicago, IL
      • Contact: Steven A Gard, PhD; Phone Number: (312) 238-6525; Email: steven.gard@va.gov
      • Contact: Rebecca Stine, MS; Phone Number: 312-503-5726; Email: rebecca.stine@va.gov
      • Principal Investigator: Steven A Gard, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ossur Power Knee; Subjects will be fitted with the Ossur Power Knee, which has powered flexion and extension.	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.
Active Comparator: Ossur Rheo XC Knee; Subjects will be fitted with the Ossur Rheo XC Knee, which is a conventional microprocessor-controlled knee joint that modulates the amount of damping during flexion and extension.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Steven A Gard, PhD, Jesse Brown VA Medical Center, Chicago, IL

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: January 11, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: prosthesis; amputation; limb deficiency; limb loss; knee joint; transfemoral; above-knee
• Other Study ID Numbers: A4541-R; RX004541-01A2 (Other Grant/Funding Number: VA RRD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. Results from this study will be freely disseminated via presentations at professional conferences and publications in scientific journals. Additionally, data acquired for this project will be shared with those investigators who make a formal request to the PI and can demonstrate a legitimate and justifiable cause for utilization of such data. All requests for these data will be discussed with the VA scientific program manager.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No