AmputationPhase 2/3NCT00888199
Clinical Trial of Tensegrity Prosthetics K3 Promoter Foot Prosthesis
A Phase 2/3 study testing Experimental prosthetic foot (K3 Promoter) in people with Amputation, run by Tensegrity Prosthetics at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation
- What is being tested?
- Experimental prosthetic foot (K3 Promoter)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jun 2010
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Gait Lab
Boulder, Colorado, 80310
Rodger Kram, Ph.D., 303-492-7984, Rodger.Kram@colorado.edu
Jerome Rifkin, MS
About this study
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.
Read the 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.
- Conditions
- Amputation
- Being tested
- Experimental prosthetic foot (K3 Promoter)
- Keywords
- amputation, amputee, prosthetic, foot, prosthesis, Tensegrity, Prosthetics, K3 Promoter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental prosthetic foot (K3 Promoter)Device
Experimental prosthetic foot
| Study group | Role | What they receive |
|---|---|---|
| Congenital/Traumatic | Experimental | Individuals who were born with a limb deficiency or who have had a traumatic amputation. Receives: Device: Experimental prosthetic foot (K3 Promoter) |
| Dysvascular/Diabetic | Experimental | Individuals who have had an amputation as a result of vascular disease. Receives: Device: Experimental prosthetic foot (K3 Promoter) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in metabolic cost of transport
Measured: 30 and 60 days after the beginning of the protocol
Stride time variability
Measured: 30 and 60 days after beginning of protocol
Secondary outcomes (2)
Amputee Mobility Predictor Questionnaire
Measured: Beginning and end of protocol
Actual change in activity as measured by a step counter
Measured: throughout protocol (60 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startJan 2010
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tensegrity Prosthetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Jerome Rifkin, MS ME, Principal investigator, Tensegrity Prosthetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888199
- Sponsor's protocol ID
- 1-Rifkin
- Status last verified
- Apr 2009
- First submitted
- 23 Apr 2009
- Last updated
- 27 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Tensegrity Prosthetics K3 Promoter Foot Prosthesis
- ClinicalTrials.gov ID
- NCT00888199
- Acronym / sponsor ID
- 1-Rifkin
- Conditions
- Amputation
- Keywords
- amputation, amputee, prosthetic, foot, prosthesis, Tensegrity, Prosthetics, K3 Promoter
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tensegrity ProstheticsIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 27 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Congenital/Traumatic | Experimental | Device: Experimental prosthetic foot (K3 Promoter)Individuals who were born with a limb deficiency or who have had a traumatic amputation. |
| Dysvascular/Diabetic | Experimental | Device: Experimental prosthetic foot (K3 Promoter)Individuals who have had an amputation as a result of vascular disease. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental prosthetic foot (K3 Promoter)Experimental prosthetic foot | Device | Congenital/Traumatic, Dysvascular/Diabetic |
Primary outcome
Change in metabolic cost of transport
Time frame: 30 and 60 days after the beginning of the protocol
Stride time variability
Time frame: 30 and 60 days after beginning of protocol
2 secondary outcomes
Amputee Mobility Predictor Questionnaire
Time frame: Beginning and end of protocol
Actual change in activity as measured by a step counter
Time frame: throughout protocol (60 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2009.
Related trials for Amputation
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
RecruitingObservational study
CNS Changes Following Upper Limb Loss
Amputation, Congenital, Upper Limb; Amelia
Recruiting
Hand Prosthesis Usability and Performance
Amputation
Recruiting
E-Socket, Diagnostic Monitoring
Trans-Tibial Amputation
RecruitingObservational study
Early Postoperative Pain Following a Limb Amputation
Amputation, Surgical, Pain Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerome Rifkin, MS ME principal investigator
Tensegrity Prosthetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Experimental prosthetic foot (K3 Promoter) in people with Amputation, run by Tensegrity Prosthetics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jerome Rifkin, MS ME (303-666-7722, jrifkin@tenspro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in metabolic cost of transport (time frame: 30 and 60 days after the beginning of the protocol). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2009.