Passive Microprocessor-controlled Knees vs. Active Microprocessor-controlled Knees After Transfemoral Amputation

Median Technologies

Status: Enrolling

Conditions: Amputation

Treatments: Device: active microprocessor-controlled knee

Study type: Observational

Funder types: Other

Identifiers

NCT06406491

Intuy2024

Details and patient eligibility

About

This study investigates prosthetic users´ report of passive microprocessor-controlled knees (pMPK) vs. active microprocessor-controlled knees (aMPK). Outcome measurements are assessed at baseline with the pMPK and after 4 weeks of continuous use of aMPK. Measurements consists of functional outcomes, as well as patient-reported outcomes.

Full description

The Intuy Knee, an active electronic microprocessor-controlled prosthesis, aims to improve symmetry in joints, torque, and muscle activation compared to passive prostheses. Furthermore, it provides benefits of active prostheses in terms of weight distribution, stair climbing ease, and reduced oxygen consumption. However, there's a lack of research on subjective evaluation by participants. Thus, the study aims to compare the Intuy Knee with passive prostheses regarding functional outcomes and patient-reported outcomes (PROMs).

The target group includes individuals with transfemoral amputation or knee disarticulation, aged 18 and above, with anticipated moderate to high mobility levels, and currently using an electronic prosthetic knee. The study plans to enroll participants nearing the end of their prosthetic cycle, allowing for comparison between different prosthetic options.

Key objectives include comparing walking distance, stair climbing, and hill ascent between passive and active prostheses, as well as evaluating mobility, daily functionality, quality of life, and fear of falling.

The study design is prospective with a pre-post design, aiming for an intra-individual comparison between active and passive prostheses. It outlines inclusion and exclusion criteria, study procedures, and discontinuation criteria for both individual and overall study termination.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• transfemoral amputation or knee-disarticulation
• passive microprocessor-controlled knee
• resupply with new prosthesis within the next few months
• K-Level 2 or 3
• body weight no more than 125 kg
• German speakers

Exclusion criteria

• age less than 18 years
• unable to give informed consent
• body weight more than 125 kg

Trial design

10 participants in 1 patient group

Subjects

Description:

Baseline measurements for all subjects is carried out with their own passive microprocessor-controlled knee prosthesis. After 4 weeks of use of active microprocessor-controlled knee, second measurement is carried out. All subjects follow the same study path.

Treatment:

Device: active microprocessor-controlled knee