NCT00888199

Brief Summary

The purpose of this clinical trial is to determine if the experimental Tensegrity prosthetic foot offers a reduction of the amount of oxygen used while walking, if stability is improved over current prosthetic feet, and whether the experimental device actually increases activity in amputees.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

April 27, 2009

Status Verified

April 1, 2009

Enrollment Period

5 months

First QC Date

April 23, 2009

Last Update Submit

April 24, 2009

Conditions

Amputation

Keywords

amputationamputeeprostheticfootprosthesisTensegrityProstheticsK3 Promoter

Outcome Measures

Primary Outcomes (2)

  • Change in metabolic cost of transport

    30 and 60 days after the beginning of the protocol

  • Stride time variability

    30 and 60 days after beginning of protocol

Secondary Outcomes (2)

  • Amputee Mobility Predictor Questionnaire

    Beginning and end of protocol

  • Actual change in activity as measured by a step counter

    throughout protocol (60 days)

Study Arms (2)

Congenital/Traumatic

EXPERIMENTAL

Individuals who were born with a limb deficiency or who have had a traumatic amputation.

Device: Experimental prosthetic foot (K3 Promoter)

Dysvascular/Diabetic

EXPERIMENTAL

Individuals who have had an amputation as a result of vascular disease.

Device: Experimental prosthetic foot (K3 Promoter)

Interventions

Experimental prosthetic foot (K3 Promoter)DEVICE

Experimental prosthetic foot

Congenital/TraumaticDysvascular/Diabetic

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • K2 or K3 classification based on current prosthetic device.
  • Males and females ≥ 18 years of age
  • Willing and able to sign informed consent
  • Able to read, write, and speak English
  • Documented to have a unilateral trans-tibial amputation
  • Actively utilizing a definitive prosthesis for at least 12 months
  • Utilizing current prosthetic foot for at least 3 months
  • Cognitively functional, in the opinion of the prosthetists'
  • Able to maintain a good gait on their existing limb for approximately 45 minutes
  • have a healthy residual limb in good condition
  • have a socket with a good, trouble-free fit on their residual limb

You may not qualify if:

  • Significant ulcers or infections associated with a compromised circulation of the other lower limb
  • Intermittent Claudication or Critical Leg Ischemia in the non-amputated leg
  • K0, K1or K4 Classification
  • Irreducible, pronounced knee or hip flexion contractures
  • Bilateral amputations
  • Use of a walker for ambulation
  • Severe arthritis that would limit the ability to stand without pain or discomfort or the subject's ability to ambulate is limited by symptoms other than the prothesis (e.g., shortness of breath, fatigue, angina, arthritis, etc.). If, in the opinion of the investigator, the subject were to improve their ability to ambulate from the K3 Promoter to the extent that his or her walking would then be limited by a symptom other than the prothesis, the subject should not be enrolled
  • Any other clinically significant medical or psychiatric condition that in the opinion of the Investigator could impact the subject's ability to successfully complete this trial
  • Advanced neurologic disorder
  • Severe congestive heart failure, angina pectoris, or obstructive pulmonary disease
  • Use of medication that causes impaired balance or judgment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Gait Lab

Boulder, Colorado, 80310, United States

Location

Study Officials

  • Jerome Rifkin, MS ME

    Tensegrity Prosthetics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jerome Rifkin, MS ME

CONTACT

303-666-7722jrifkin@tenspro.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 23, 2009

First Posted

April 27, 2009

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

April 27, 2009

Record last verified: 2009-04

Locations

US(1)