Reverse Innovation in Western Health Care: the ReMotion Prosthetic Knee.

NCT04700085 | Completed

• 1 other identifier: 837_ReMotion_Knee
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Ambulatory mobility and function are important aspects in the quality of life of people with lower limb amputations and prostheses. Regaining mobility is often challenging, especially for patients with transfemoral, or above-knee, amputations. In the past decades, new types of knee prosthetics have entered the market. The standard care in Europe and the US at this moment is the mechanical, or non-microprocessor controlled, knee (NMPK). While the production costs of these NMPK's are lower than those of the MPK's (microprocessor controlled knee), consumer prices still reach up to $5000. Recently, the ReMotion Knee ($80) was developed as a new and affordable alternative to the currently available mechanical knees. The ReMotion Knee is mostly used in low-income countries, but has now been approved according to the ISO 10328 standards and has received the CE Mark. This knee could be a more affordable alternative for the prosthetic knees used in high-income countries, thereby decreasing health related costs within the amputation population. However, research on patient's functional abilities and personal experiences with the knee is very limited and has not been investigated within more developed countries. Therefore, the objective of this study is to compare the ReMotion Knee and the current prosthetic knee of patients with a transfemoral amputation or knee-exarticulation in terms of functional mobility, balance, and experienced walking comfort, balance trust, fatigue and performance of the knee. it is expected that the ReMotion Knee will perform slightly worse than the participants' current prosthetic knees.

Conditions

Lower Limb Amputation Above Knee (Injury); Lower Limb Amputation Knee

Outcome Measures

Primary Outcomes (1)

• L-test

  Measure for functional mobility

  5 minutes

Secondary Outcomes (8)

• Four Square Step Test (FSST)

  5 minutes

• Berg Balance Scale (BBS)

  15 minutes

• Weight distribution during static stance

  2 minutes

• Modified Emory Functional Amputation Profile (mEFAP)

  5 minutes

• Experienced walking comfort

  On average, after 30 minutes and after 90 minutes

Study Arms (2)

ReMotion Knee

EXPERIMENTAL

The ReMotion Knee (mechanical prosthetic knee type) was used during measurements

Device: ReMotion Knee

Current prosthetic knee

NO INTERVENTION

The participant's current prosthetic knee was used during measurements

Interventions

ReMotion Knee DEVICE

The ReMotion Knee is a prosthetic knee mostly used in low-income countries. It has been approved according to the ISO 10328 standards and has received the CE Mark.

ReMotion Knee

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medicare Functional Classification Level (MFCL) 2 or 3 (most probable users of the ReMotion Knee)
• at least one year since amputation
• currently using a polycentric mechanical prosthetic knee.

You may not qualify if:

• stump pain that increases with activity
• a hip flexion contracture \> 20 degrees
• inability to stand and walk for thirty minutes
• weight \>80kg (weight limit of the ReMotion Knee)
• a prosthetic socket connection that did not fit the ReMotion Knee
• an osseointegrated prosthesis

Sponsors & Collaborators

• Sint Maartenskliniek: lead

Study Sites (1)

Sint Maartenskliniek

Ubbergen, Gelderland, 6574NA, Netherlands

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Noël LW Keijsers, PhD

  Sint Maartenskliniek

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants and researcher could not be blinded as participants performed a training session with the ReMotion Knee (one of the conditions) and the prosthetic knee type was visible to both.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized crossover trial design

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 7, 2021
• Study Start: February 27, 2019
• Primary Completion: August 7, 2019
• Study Completion: August 7, 2019
• Last Updated: January 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)