Recruiting

MPK

Sponsor:

Hanger Institute for Clinical Research and Education, LLC

Code:

NCT06937242

Conditions

Amputation

Prosthesis User

Amputation; Traumatic, Leg: Thigh, Between Hip and Knee

Limb; Absence, Congenital, Lower

Lower Limb Amputation Above Knee (Injury)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ottobock C-Leg 4 Microprocessor Knee

Ottobock Kenevo

Study Details

Brief summary:

The goal of this study is to find out if using microprocessor-controlled prosthetic knees (MPKs), prosthetic knees with a built-in computer, improves health outcomes related to falls in adults who use above-knee prostheses. The main questions are:

  • Do individuals with MPKs have fewer fall-related health issues compared to those with non-microprocessor-controlled prosthetic knees (nMPKs)?
  • Do individuals with MPKs have increased mobility, faster walking speed, and improved quality of life compared to those with nMPKs?

Participants who have recently received an nMPK as part of their regular care can join the study. Those randomized to the control group will keep using their nMPK, while those randomized to the intervention group will receive a stance-and-swing MPK or a stance-only MPK.

Conditions

Amputation

Prosthesis User

Amputation; Traumatic, Leg: Thigh, Between Hip and Knee

Limb; Absence, Congenital, Lower

Lower Limb Amputation Above Knee (Injury)

Study ID

NCT06937242

Start date

Jul 11, 2025

Status verified date

Feb, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Unilateral transfemoral or knee disarticulation limb loss.
  • 6 months or longer since time of limb loss.
  • Current user of a prosthesis with a non-microprocessor-controlled prosthetic knee.
  • Received a replacement prosthesis with a non-microprocessor knee in the past 4-24 months.
  • Clinician has deemed patient limited community ambulator (Medicare functional classification level K2).
  • In addition, Medicare functional classification level K2 as determined by at least one of the following criteria:

1. Houghton Score: 5-10
2. Prosthetic Limb Users Survey of Mobility (PLUS-M) T-Score: if amputation etiology is vascular disease/diabetes <49.45, otherwise, <36.75.
3. Amputee Mobility Predictor (AMPPRO) score: 27-42 collected within the last 24 months
  • Ability to read, write, and understand English.

Exclusion Criteria:

  • Any health condition that would prevent safely completing trial activities.
  • Any individuals that weigh 275 lbs or more.
  • Any individuals who wear their prosthesis less than 3 days a week or less than a total of 24 hours a week
  • Individuals with a history of acute or chronic residual limb breakdown
  • Individuals with declining health status such that he/she subsequently reports reduced activity over the past 6 months

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: MPK (Ottobock C-Leg 4 or Ottobock Kenevo)

The MPK provided to each participant in the intervention arm will be determined by the manufacturer's recommended patient-selection criteria.

no intervention: nMPK

Participants in the control arm of the trial will remain in their prescribed non-microprocessor knee (nMPK) prosthesis

Interventions

Ottobock C-Leg 4 Microprocessor Knee

Subjects in the intervention group who can walk more than 0.83m/s in the 2-minute walk test (2MWT) will receive the Ottobock C-Leg 4, a stance-and-swing microprocessor knee.

Ottobock Kenevo

Subjects in the intervention group who can walk up to 0.83m/s (3km/hr) in the 2-minute walk test (2MWT) will receive the Kenevo, a stance-only microprocessor knee.

Primary outcome measure

  • Prosthetic Limb Users Survey of Fall-Related Self-Efficacy (PLUS-F-SEF) [ Time Frame: Collected at baseline, 1-month, 3-month, 6-month, 9-month, and 12-month assessments. ]
  • Prosthetic Limb Users Survey of Fall-Related Anxiety (PLUS-F-ANX) [ Time Frame: Collected at baseline, 1-month, 3-month, 6-month, 9-month, and 12-month assessments. ]
  • Prosthetic Limb Users Survey of Fall-Related Avoidance Behaviors (PLUS-F-AVB) [ Time Frame: Collected at baseline, 1-month, 3-month, 6-month, 9-month, and 12-month assessments. ]
  • Prosthetic Limb Users Survey of Fall-Related Interference (PLUS-F-INT) [ Time Frame: Collected at baseline, 1-month, 3-month, 6-month, 9-month, and 12-month assessments. ]
  • Number of Reported Falls and Near-Fall Events [ Time Frame: Collected every two weeks starting at baseline up to 12 months ]

Central Contacts and Locations

Central contacts

Shane R. Wurdeman, PhD

281-829-4746swurdeman@hanger.com

Bretta L. Fylstra, PhD

512-994-6685bfylstra@hanger.com

Locations

Hanger Inc.

Recruiting

Austin, Texas, United States, 78758

Contacts

Shane R. Wurdeman, PhD

281-829-4746swurdeman@hanger.com

Bretta L. Fystra, PhD

512-994-6685bfylstra@hanger.com

Principal Investigator:

Shane R. Wurdeman, PhD

More Information

Sponsor

Hanger Institute for Clinical Research and Education, LLC

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

  • amputation
  • lower limb amputation
  • lower limb prosthesis user
  • mechanical knee
  • microprocessor knee
  • transfemoral amputation
  • knee disarticulation
  • prosthetic knee
  • falls
  • falling
  • amputee
  • transfemoral amputee
  • MPK

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hanger Institute for Clinical Research and Education, LLC on 2026-02-05.