NCT02240186

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
1 year until next milestone

Results Posted

Study results publicly available

December 12, 2018

Completed
Last Updated

December 12, 2018

Status Verified

December 1, 2018

Enrollment Period

3 years

First QC Date

September 8, 2014

Results QC Date

October 3, 2018

Last Update Submit

December 11, 2018

Conditions

Lower Limb Amputation Above Knee (Injury)

Keywords

Microprocessor-controlled kneeprosthesisamputation

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (1)

  • Patient Satisfaction as Assessed by the Prosthesis Evaluation Questionnaire (PEQ)

    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)

Study Arms (1)

Prosthetic knee joints

EXPERIMENTAL

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.

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

Interventions

Microprocessor Knee (MPK)DEVICE

MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.

Prosthetic knee joints
Non-Microprocessor Knee (NMPK)DEVICE

A NMPK is a mechanical knee with either hydraulic or pneumatic controls.

Prosthetic knee joints

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related 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). 2018 Oct;58:116-122. doi: 10.1016/j.clinbiomech.2018.07.012. Epub 2018 Jul 19.

    PMID: 30077128RESULT

MeSH Terms

Conditions

Wounds and Injuries

Results Point of Contact

Title
Dr. Kenton Kaufman, Principal Investigator
Organization
Mayo Clinic
kaufman.kenton@mayo.edu
507-284-2262

Study Officials

  • Kenton R Kaufman, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Biomedical Engineering, College of Medicine

Study Record Dates

First Submitted

September 8, 2014

First Posted

September 15, 2014

Study Start

June 1, 2014

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

December 12, 2018

Results First Posted

December 12, 2018

Record last verified: 2018-12

Locations

US(1)