Assessing Outcomes With Microprocessor Knee Utilization in a K2 Population

Not Applicable

Active, not recruiting

• Conditions: Lower Limb Amputation Above Knee (Injury); Lower Limb Amputation Knee; Congenital Amputation of Lower Limb

• Registration Number: NCT04784429
• Lead Sponsor: Otto Bock Healthcare Products GmbH

Brief Summary

Two-phased randomized controlled trial comparing the impact of microprocessor controlled knee prostheses (MPK) with the impact of non-microprocessor controlled knee prostheses (NPMK) in patients with a transfemoral/knee disarticulation level amputation categorized as K2 ambulators.

Detailed Description

Randomized controlled trial investigating the benefits of microprocessor controlled knee prostheses (MPK) in patients with a transfemoral or knee disarticulation level amputation categorized by Medicare Functional Classification Level (MFCL) as a Limited Community Ambulator (K-Level 2). There are two aims for the study. Aim 1 is to understand the effect of MPK technology for the K2 ambulator on reducing fear and anxiety of falling, improving health-related quality of life, and participation in society and activities. Aim 2 is to understand the long-term effect of MPK technology the aspects from Aim 1 as well as reducing morbidity. The trial will be conducted in two phases. Phase 1 will cover the initial 12-month period to address Aim 1, and phase 2 will monitor from 12 months to 5 years to address Aim 2.

Study Timeline

• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-05
• Study Start: 2021-06-11
• Primary Completion: 2023-06-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-09
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• Unilateral transfemoral or knee disarticulation amputation
• Received prosthesis between 4 - 24 months prior
• Currently uses prosthesis
• K2 ambulator status
• Able to speak English or Spanish language
• Age ≥ 65 years at Baseline Assessment (one month after enrollment)
• Minimum Socket Comfort Score (SCS) of 6/10

Exclusion Criteria

• Upper limb involvement
• Individuals ≥ 275 lbs
• Unable to provide informed consent
• History of acute or chronic residual limb breakdown
• History of 2 or more socket adjustments or replacements in the past 6 months
• Amputation of the contralateral limb
• Active malignancy
• Rapidly declining health status resulting in reduced activity in the past 6 months, as determined by patient's clinician and confirmed by Clinical & Scientific Affairs personnel
• Patient unable or unwilling to follow study procedures
• Pregnant women, institutionalized persons, and children

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fear of Falling Avoidance Behavior Questionnaire (FFABQ)	5 years	This is a 14 item survey assessment originally developed with community-dwelling older adults which measures the degree to which respondents avoid activities due to their fear of falling. Responses are on a 5-point scale with 0 = completely disagree and 4 = completely agree. The total possible score is 56 points. A higher score indicates a greater activity limitation and participation restriction as a result of the fear of falling.

Secondary Outcome Measures

Name	Time	Method
Patient-Reported Outcomes Measurement Information System (PROMIS) - Ability to Participate in Social Roles and Activities (APSRA)	3 years	Within the PROMIS system, this specific set of question is aimed at assessing the person's ability to perform usual social roles and activities, a construct noted to be of great significance to well-being within the World Health Organization International Classification of Function model. Four of the PROMIS-APSRA questions are included on the PROMIS-29 within the domain of 'satisfaction with social roles'. The addition of four more questions helps with the responsiveness within this specific domain. Thus the additional four questions of the PROMIS-APSRA will be administered to assess the domain of participation and activity.
Patient-Reported Outcomes Measurement Information System (PROMIS) - 29	3 years	Difference in average daily step activity count from 1 week after initial assessment compared to average daily step activity count for 1 week prior to 5-year assessment. Modern activity monitors provide the ability to translate movement from triaxial inertial measurement units into corresponding step activity with great precision.
Average daily step counts	12 months	Difference in average daily step activity count from 1 week after initial assessment compared to average daily step activity count for 1 week prior to 12-month assessment. Modern activity monitors provide the ability to translate movement from triaxial inertial measurement units into corresponding step activity with great precision.
12-month fall count from bi-weekly fall journal	12 months	On a bi-weekly cadence, individuals will be asked to complete the Lower Limb Amputation Fall Survey. This survey was developed for the purpose of documenting number of falls and near-falls over a given period, as well as insight into the causality.
Fear of Falling Avoidance Behavior Questionnaire (FFABQ)	3 years	This is a 14 item survey assessment originally developed with community-dwelling older adults which measures the degree to which respondents avoid activities due to their fear of falling. Responses are on a 5-point scale with 0 = completely disagree and 4 = completely agree. The total possible score is 56 points. A higher score indicates a greater activity limitation and participation restriction as a result of the fear of falling.
10-meter Walk Test (10mWT)	3 years	The 10mWT is a standardized test of self-selected walking speed in which patients are timed over the middle 6 meters (19.7 feet) of a 10-meter (32.8 feet) flat walkway. The self-selected walking speed is calculated in meters per second and has been discussed as a potential vital sign given its strong relationship with survival. It will serve as a marker of morbidity.
Timed Up and Go (TUG)	3 years	The Timed Up-and-Go test is a standard basic mobility test that includes a sit-to-stand, gait initiation, walking, turning, and stand-to-sit. The test measures, in seconds, the time to stand up from an arm chair, walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair and sit down. It is a measure of function, has been used to assess the risk of falling, and will serve as a marker of morbidity.

Trial Locations

Locations (90)

Hanger Clinic - 321 Westgate Pkwy; 🇺🇸 Dothan, Alabama, United States

Hanger Clinic - 3501 S Mercy Road; 🇺🇸 Gilbert, Arizona, United States

Hanger Clinic - 3816 N. 7th St.; 🇺🇸 Phoenix, Arizona, United States

Hanger Clinic - 4045 E Bell Rd; 🇺🇸 Phoenix, Arizona, United States

Hanger Clinic - 13925 Meeker Blvd, Suite 5; 🇺🇸 Sun City West, Arizona, United States

Hanger Clinic - 4849 Lonetree Way, STE B; 🇺🇸 Antioch, California, United States

Hanger Clinic - 1743 Creekside, Suite #110; 🇺🇸 Folsom, California, United States

Hanger Clinic - California - 1248 32nd St; 🇺🇸 Sacramento, California, United States

Hanger Clinic - 23451 Madison St., Suite 200, Skypark Building 7; 🇺🇸 Torrance, California, United States

Hanger Clinic - 820 S Akers St, Ste 230; 🇺🇸 Visalia, California, United States

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