Use of Passive, Adaptive, and Active Prosthetic Knees in Persons With Unilateral, Transfemoral Amputation

NCT ID: NCT02219230

Last Updated: 2015-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-09-30

Brief Summary

The goals of this study are to assess measured, observed, and self-reported outcomes achieved through the use of passive (mechanical), active(motorized) and adaptive (magnetorheological) prosthetic knee control systems in individuals with unilateral, transfemoral amputation.

Detailed Description

An interrupted time-series trial with pre/post baseline assessments, randomized crossover of interventions, and within-phase repeated measures is used to evaluate and compare the effectiveness of the Össur Power Knee II and the Össur Rheo Knee in individuals with unilateral, transfemoral amputation. A rigorous and clinically-meaningful experimental protocol is applied to verify study participants receive appropriate training, experience, and assessment in each knee condition. A suite of standardized and ad-hoc physical performance tests, patient-reported questionnaires, and monitoring technologies were carefully selected to assess important, clinically-relevant participant outcomes. Comparative effectiveness of three prosthetic knee interventions are evaluated using direct measurement (i.e., timed tests), observed clinical ratings (i.e., subjective assessments of gait quality) and self-report instruments (i.e., health status surveys). Analyses will focus on identifying differences between control system technologies inherent to each type of prosthetic knee (i.e., passive [mechanical], adaptive [magnetorheological], and active [power]). Outcomes will be used to establish recommendations for which activities and patients knees are most appropriate or likely to produce a desired effect.

Conditions

Transfemoral Amputation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: SINGLE

Study Groups

Prosthetic knee

Subjects crossed over between interventions (three different prosthetic knees). Knee conditions include 1) Active knee (Ossur Power Knee II); 2) Adaptive knee (Ossur Rheo); and 3) Passive knee (Various manufacturers)

Group Type: EXPERIMENTAL

Active knee (Ossur Power Knee II)

Intervention Type: DEVICE

Prosthetic knee with active control system.

Adaptive knee (Ossur Rheo)

Intervention Type: DEVICE

Prosthetic knee with adaptive control system.

Passive knee (Various manufacturers)

Intervention Type: DEVICE

Prosthetic knee with mechanical control system.

Interventions

Active knee (Ossur Power Knee II)

Prosthetic knee with active control system.

Intervention Type: DEVICE

Adaptive knee (Ossur Rheo)

Prosthetic knee with adaptive control system.

Intervention Type: DEVICE

Passive knee (Various manufacturers)

Prosthetic knee with mechanical control system.

Intervention Type: DEVICE

Other Intervention Names

Power knee; Motorized knee; Magnetorheological knee; Microprocessor knee; Mechanical knee; Hydraulic knee; Pneumatic knee

Eligibility Criteria

Inclusion Criteria

• age 45 - 75
• body weight less than 275lbs
• unilateral amputation between the hip and knee
• amputation due to non-vascular causes
• no other major limb amputations
• amputation occurred at least 2 years prior
• stable limb volume (i.e., at least 6 months on an unmodified prosthetic socket)
• intact skin tissue without open wounds or sores for at least 2 months
• physiologically stable medical condition (i.e., non-degenerative)
• possession and regular (i.e., daily) use of a prosthesis with a prosthetic knee with non-microprocessor (i.e., mechanical or fluid) stance control
• Medicare functional classification level (MFCL or "K-level") 3

Exclusion Criteria

• expect to receive or are expected to require a replacement prosthetic socket within 15 months
• complete reliance on an assistive device (i.e., cane or walker) for ambulation

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Össur Iceland ehf

INDUSTRY

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Brian Hafner

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian Hafner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

References

Hafner BJ, Askew RL. Physical performance and self-report outcomes associated with use of passive, adaptive, and active prosthetic knees in persons with unilateral, transfemoral amputation: Randomized crossover trial. J Rehabil Res Dev. 2015;52(6):677-700. doi: 10.1682/JRRD.2014.09.0210.

Reference Type: RESULT

PMID: 26560243 (View on PubMed)

Other Identifiers

A62089

Identifier Type: OTHER

Identifier Source: secondary_id

40660-A

Identifier Type: -

Identifier Source: org_study_id