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Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees

NCT ID: NCT02240186

Last Updated: 2018-12-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Lower Limb Amputation Above Knee (Injury)

Keywords

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Microprocessor-controlled knee prosthesis amputation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prosthetic knee joints

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.

Group Type EXPERIMENTAL

Microprocessor Knee (MPK)

Intervention Type DEVICE

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

Non-Microprocessor Knee (NMPK)

Intervention Type DEVICE

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

Interventions

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Microprocessor Knee (MPK)

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

Intervention Type DEVICE

Non-Microprocessor Knee (NMPK)

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Orthotic and Prosthetic Association

OTHER

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Kenton R. Kaufman, Ph.D.

Professor of Biomedical Engineering, College of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kenton R Kaufman, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 30077128 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Foundation

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

14-002930

Identifier Type: -

Identifier Source: org_study_id