Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees (MPK-AOPA)

Mayo Clinic

Status: Completed

Conditions: Lower Limb Amputation Above Knee (Injury)

Treatments: Device: Microprocessor Knee (MPK); Device: Non-Microprocessor Knee (NMPK)

Study type: Interventional

Funder types: Other

Identifiers

NCT02240186

Foundation (Other Grant/Funding Number)

14-002930

Details and patient eligibility

About

This study will assess if the functional performance and musculoskeletal outcome of transfemoral amputees are improved after receiving a Microprocessor Knee (MPK) compared to a Non-Microprocessor Knees (NMPK).

Full description

The study design is a reversal design whereby only the prosthetic knee joint will be changed. Each subject will be tested using their current NMPK, fit and tested with a MPK, and then tested again with their NMPK. MPK prostheses from all manufacturers will be considered appropriate for testing. Each MPK to be used in this study is FDA approved. The foot will be in the L5981 class, e.g. flex foot or equivalent. The same socket, suspension, and foot will be used throughout the study in order to eliminate these confounding variables. All prosthesis fittings will be performed by the subject's own certified prosthetist according to manufacturers' fitting guidelines.

Enrollment: 50 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Unilateral transfemoral amputee
• Medicare Functional Classification Level K2 or K3
• Currently using NMPK prosthesis
• No current residual limb problems, such as skin breakdown
• Able to ambulate without a gait aid

Exclusion criteria

• Previous stroke or other neuromuscular complications currently affecting gait
• Currently undergoing dialysis treatments
• Amputation of the contralateral limb
• Poor fit of current NMPK prosthesis

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Prosthetic knee joints

Experimental group

Description:

Each subject will be tested using their current Non-Microprocessor Knee (NMPK) , fit and tested with a Microprocessor Knee (MPK), and then tested again with their NMPK, e.g. A-B-A design.

Treatment:

Device: Microprocessor Knee (MPK)

Device: Non-Microprocessor Knee (NMPK)