Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees

Lower Limb Amputation Above Knee (Injury) Clinical Trial

— MPK-AOPA  

Official title:

Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02240186
• Other study ID #: 14-002930
• Secondary ID: Foundation
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: December 2017

Study information

• Verified date: December 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Limb Amputation Above Knee (Injury)

Intervention

Device:
• Microprocessor Knee (MPK)
MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.
• Non-Microprocessor Knee (NMPK)
A NMPK is a mechanical knee with either hydraulic or pneumatic controls.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	American Orthotic and Prosthetic Association

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kaufman KR, Bernhardt KA, Symms K. Functional assessment and satisfaction of transfemoral amputees with low mobility (FASTK2): A clinical trial of microprocessor-controlled vs. non-microprocessor-controlled knees. Clin Biomech (Bristol, Avon). 2018 Oct;58 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily Activity Measured With Triaxial Accelerometers	Measurements will be obtained three times using activity monitors attached to waist, and bilaterally to the ankle and thigh for a period of 4 consecutive days, including 2 weekdays and 2 weekend days. Primary outcome will be the difference in activity level between the NMPK and MPK measurements.	Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)
Primary	Falls as Assessed by the Prosthesis Evaluation Questionnaire Addendum (PEQ-A)	The Prosthesis Evaluation Questionnaire (PEQ) addendum (PEQ-A) is a self-administered questionnaire to quantify balance confidence, concentration, stumbles, and falls. The outcome will be difference in falls per month between the Non-Microprocessor Knee (NPMK) and MPK measurements. The number of falls was recorded as the sum of items #5 and #7 in the PEQ-A.	Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)
Secondary	Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ)	The condition-specific Prosthesis Evaluation Questionnaire (PEQ) was used to quantify patient satisfaction with each prosthesis. The outcome was a difference in PEQ scores between the NPMK and MPK measurements.; The PEQ is a self-administered questionnaire composed of nine validated scales (ambulation, appearance, frustration, perceived response, residual limb health, social burden, sounds, utility, well being). Scores range from 0 to 100 for each sub-scale. Higher scores indicated a higher functioning prosthesis/quality of life.	Baseline (tested on subjects' current NMPK), 10 weeks (after 10 weeks acclimation time to the study MPK) , 4 weeks (subjects placed back on NMPK and tested after 4 weeks re-acclimation time)