Clinical Trial of Tensegrity Prosthetics K3 Promoter Foot Prosthesis

Status unconfirmed · Phase 2/Phase 3

Conditions studied: Amputation

In brief

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.

Key facts

Study ID

NCT00888199

Run by

Tensegrity Prosthetics

People needed

80

Starts

2010-01-01

Expected to finish

2010-06-01

Last updated by the study team

2009-04-27

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• University of Colorado Gait Lab — Boulder, Colorado, United States

Full record on ClinicalTrials.gov

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