NCT04700085

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

Completed NA Last updated 7 January 2021

What this trial tests

NA trial testing ReMotion Knee in Lower Limb Amputation Above Knee (Injury) in 9 participants. Completed in 7 August 2019.

Timeline

27 February 2019

Primary endpoint
7 August 2019

7 August 2019

Quick facts

Lead sponsor	Sint Maartenskliniek
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	supportive care
Enrollment	9
Start date	27 February 2019
Primary completion	7 August 2019
Estimated completion	7 August 2019
Sites	1 location across Netherlands

Drugs / interventions tested

• ReMotion Knee

Conditions studied

• Lower Limb Amputation Above Knee (Injury) — all drugs for Lower Limb Amputation Above Knee (Injury) →
• Lower Limb Amputation Knee — all drugs for Lower Limb Amputation Knee →

Sponsor

Sint Maartenskliniek — full company profile →

Who can join

18 and older, any sex, with Lower Limb Amputation Above Knee (Injury) or Lower Limb Amputation Knee. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.