Comparative Performance of Dynamic Elastic Response Feet

NCT02542761 | Completed Results FDA Device

• 1 other identifier: 15-001367
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to compare the functional performance of individuals with transtibial amputation using two types of prosthetic foot designs: carbon fiber vs. fiberglass composite.

Conditions

Transtibial Amputation - Unilateral

Outcome Measures

Primary Outcomes (1)

• Peak Ankle Dorsiflexion During Stance

  The peak ankle dorsiflexion is the peak ankle backward flexion or bending when walking.

  After approximate 4 week acclimation period

Secondary Outcomes (5)

• Peak Ankle Plantar Flexor Moment During Stance

  After approximate 4 week acclimation period

• Peak Ankle Power Generation

  After approximate 4 week acclimation period

• Peak Knee Flexion During Swing

  After approximate 4 week acclimation period

• Time of Peak Knee Flexion During Swing

  After approximate 4 week acclimation period

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

  After approximate 4 week acclimation period

Study Arms (2)

CFPF first, then FPF

EXPERIMENTAL

After a 4 week acclimation period, subjects were studied on their current carbon fiber composite foot (CFPF), followed by another 4 week acclimation period, then studied on the study provided fiberglass composite foot (FPF).

Device: Fiberglass Composite foot; Device: Carbon Fiber Composite Foot

FPF first, then CFPF

EXPERIMENTAL

After a 4 week acclimation period, subjects were studied on the study provided fiberglass composite foot (FPF), followed by another 4 week acclimation period, then studied on their current carbon fiber composite foot (CFPF).

Device: Fiberglass Composite foot; Device: Carbon Fiber Composite Foot

Interventions

Fiberglass Composite foot DEVICE

The Rush foot is a fiberglass composite energy storage and return prosthetic foot.

Also known as: Rush Foot

CFPF first, then FPF; FPF first, then CFPF

Carbon Fiber Composite Foot DEVICE

All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate.

Also known as: Otto Bock Triton, Ossur Variflex, Ossur Variflex EVO, Ossur Reflex Shock, Freedom Renegade, Freedom Pacifica, Freedom Thrive with Vertical Shock, Freedom Highlander, Freedom Agilix

CFPF first, then FPF; FPF first, then CFPF

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral transtibial amputee
• Currently using a carbon fiber prosthetic (DER) foot for at least the last 6 months
• Stable stump volume over the past 6 months
• Medicare Functional Classification Level K3 or K4

You may not qualify if:

• Neuromuscular problems such as previous stroke or contralateral amputation
• Use of gait aids for ambulation
• Undergoing dialysis
• Poor prosthetic socket fit or stump problems (e.g., skin breakdown)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Kaufman KR, Bernhardt K. Functional performance differences between carbon fiber and fiberglass prosthetic feet. Prosthet Orthot Int. 2021 Jun 1;45(3):205-213. doi: 10.1097/PXR.0000000000000004.

  PMID: 33856155 DERIVED

Results Point of Contact

• Title: Kenton Kaufman, Ph.D.
• Organization: Mayo Clinic

Kaufman.Kenton@mayo.edu

507-266-0136

Study Officials

• Kenton R Kaufman, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: This was a repeated measures cross-over trial whereby only the prosthetic foot was changed. Each subject was tested using their current carbon-fiber prosthetic foot (CFPF), and the fiberglass prosthetic foot (FPF). Half of the subjects began the study on the CFPF while the other half began on the FPF. Each subject was given an acclimation period of 4 weeks before testing.

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: September 7, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2016
• Last Updated: September 20, 2018
• Results First Posted: September 8, 2017

Record last verified: 2018-08

Locations

US (1)