Clinical Trial of Tensegrity Prosthetics K3 Promoter Foot Prosthesis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Tensegrity Prosthetics.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
Tensegrity Prosthetics
ClinicalTrials.gov Identifier:
NCT00888199
First received: April 23, 2009
Last updated: April 24, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Amputation
Device: Experimental prosthetic foot (K3 Promoter)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial of Tensegrity Prosthetics K3 Promoter Foot Prosthesis

Resource links provided by NLM:


Further study details as provided by Tensegrity Prosthetics:

Primary Outcome Measures:
  • Change in metabolic cost of transport [ Time Frame: 30 and 60 days after the beginning of the protocol ] [ Designated as safety issue: No ]
  • Stride time variability [ Time Frame: 30 and 60 days after beginning of protocol ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amputee Mobility Predictor Questionnaire [ Time Frame: Beginning and end of protocol ] [ Designated as safety issue: No ]
  • Actual change in activity as measured by a step counter [ Time Frame: throughout protocol (60 days) ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2010
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Congenital/Traumatic
Individuals who were born with a limb deficiency or who have had a traumatic amputation.
Device: Experimental prosthetic foot (K3 Promoter)
Experimental prosthetic foot
Experimental: Dysvascular/Diabetic
Individuals who have had an amputation as a result of vascular disease.
Device: Experimental prosthetic foot (K3 Promoter)
Experimental prosthetic foot

Detailed Description:

Tensegrity Prosthetics' objectives are to test whether the K3 Promoter prosthetic foot affects walking efficiency or stability in trans-tibial unilateral amputees when compared to their current prostheses. The primary objectives are to determine if the experimental foot changes Cost of Transport (ml O2/kg/meter) or Stride Time Variability compared to an amputee's current prosthesis. Cost of Transport is an indicator of metabolic efficiency and Stride Time Variability indicates how likely a person is to fall. Oxygen consumption and stride time will be collected on a treadmill at the Gait and Motion Lab at the University of Colorado in Boulder.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Significant ulcers or infections associated with a compromised circulation of the other lower limb
  2. Intermittent Claudication or Critical Leg Ischemia in the non-amputated leg
  3. K0, K1or K4 Classification
  4. Irreducible, pronounced knee or hip flexion contractures
  5. Bilateral amputations
  6. Use of a walker for ambulation
  7. 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
  8. 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
  9. Advanced neurologic disorder
  10. Severe congestive heart failure, angina pectoris, or obstructive pulmonary disease
  11. Use of medication that causes impaired balance or judgment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888199

Contacts
Contact: Jerome Rifkin, MS ME 303-666-7722 jrifkin@tenspro.com

Locations
United States, Colorado
University of Colorado Gait Lab Not yet recruiting
Boulder, Colorado, United States, 80310
Contact: Rodger Kram, Ph.D.    303-492-7984    Rodger.Kram@colorado.edu   
Principal Investigator: Jerome Rifkin, MS         
Sponsors and Collaborators
Tensegrity Prosthetics
Investigators
Principal Investigator: Jerome Rifkin, MS ME Tensegrity Prosthetics
  More Information

No publications provided

Responsible Party: Jerome Rifkin/CEO & CTO, Tensegrity Prosthetics
ClinicalTrials.gov Identifier: NCT00888199     History of Changes
Other Study ID Numbers: 1-Rifkin
Study First Received: April 23, 2009
Last Updated: April 24, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Tensegrity Prosthetics:
amputation
amputee
prosthetic
foot
prosthesis
Tensegrity
Prosthetics
K3 Promoter

ClinicalTrials.gov processed this record on August 21, 2014