Clinical Trial of Tensegrity Prosthetics K3 Promoter Foot Prosthesis

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.

Study Overview

• Status: Unknown
• Conditions: Amputation
• Intervention / Treatment: Device: Experimental prosthetic foot (K3 Promoter)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Jerome Rifkin, MS ME; Phone Number: 303-666-7722; Email: jrifkin@tenspro.com

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80310
      • University of Colorado Gait Lab
      • Contact: Rodger Kram, Ph.D.; Phone Number: 303-492-7984; Email: Rodger.Kram@colorado.edu
      • Principal Investigator: Jerome Rifkin, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Amputee Mobility Predictor Questionnaire	Beginning and end of protocol
Actual change in activity as measured by a step counter	throughout protocol (60 days)

Collaborators and Investigators

• Sponsor: Tensegrity Prosthetics
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Jerome Rifkin, MS ME, Tensegrity Prosthetics

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): June 1, 2010
• Study Completion (Anticipated): June 1, 2010

Study Registration Dates

• First Submitted: April 23, 2009
• First Submitted That Met QC Criteria: April 24, 2009
• First Posted (Estimate): April 27, 2009

Study Record Updates

• Last Update Posted (Estimate): April 27, 2009
• Last Update Submitted That Met QC Criteria: April 24, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: prosthesis; amputee; amputation; foot; prosthetic; Prosthetics; Tensegrity; K3 Promoter
• Other Study ID Numbers: 1-Rifkin