Clinical Trial of Tensegrity Prosthetics K3 Promoter Foot Prosthesis

Amputation Clinical Trial

Official title:

Clinical Trial of Tensegrity Prosthetics K3 Promoter Foot Prosthesis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00888199
• Other study ID #: 1-Rifkin
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: April 23, 2009
• Last updated: April 24, 2009
• Start date: January 2010
• Est. completion date: June 2010

Study information

• Verified date: April 2009
• Source: Tensegrity Prosthetics
• Contact: Jerome Rifkin, MS ME
• Phone: 303-666-7722
• Email: jrifkin[@]tenspro.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amputation

Intervention

Device:
• Experimental prosthetic foot (K3 Promoter)
Experimental prosthetic foot

Locations

Country	Name	City	State
United States	University of Colorado Gait Lab	Boulder	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Tensegrity Prosthetics	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in metabolic cost of transport		30 and 60 days after the beginning of the protocol	No
Primary	Stride time variability		30 and 60 days after beginning of protocol	No
Secondary	Amputee Mobility Predictor Questionnaire		Beginning and end of protocol	No
Secondary	Actual change in activity as measured by a step counter		throughout protocol (60 days)	No