Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot
Completed · Not applicable
Conditions studied: Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Knee
In brief
A prospective, interventional, multicenter pilot study to characterize differences in performance and patient reported outcomes between the Taleo, Proflex XC, and the new Revo prosthetic foot.
Key facts
- Study ID
- NCT04239222
- Run by
- Otto Bock Healthcare Products GmbH
- People needed
- 27
- Starts
- 2020-03-10
- Expected to finish
- 2022-03-11
- Last updated by the study team
- 2024-09-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Person is 18 years or older.
- Currently uses an energy storage and return foot.
- Person has been a unilateral transfemoral (TF), or transtibial (TT) amputee using a prosthesis for at least 1 year.
- For TF amputees, the person must be wearing an Ottobock Microprocessor-controlled Knee (MPK) with a compatible prosthetic foot
- Person weighs ≤ 275 lbs (125 kg) size 26-27cm or ≤ 220 lbs (100 kg) size 24-25cm
- Person is a K3 ambulator based on Medicare Functional Classification Level (MFCL).
- Prosthetic foot size is 24 to 27 centimeters.
- Socket Comfort Score of at least 7
- Ability to read and understand English
- A person is able and willing to give consent
You may not qualify if…
- Current prosthetic foot is too old or worn out as assessed by the CPO.
- TT subject with currently fit with a Proflex XC or TF subject currently fit with a Taleo.
- Patient is pregnant or planning to become pregnant.
- Person who has a life-threatening medical condition (i.e. terminal cancer, severe heart disease).
- Person has conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking, problems with vestibular system, etc.).
- Ulceration or skin breakdown of the residual limb.
- Person currently has residual limb issues that significantly reduce their ability to load the prosthesis.
Where it is running
- Artificial Limb Specialists — Mesa, Arizona, United States
- Dankmeyer Prosthetics & Orthotics — Linthicum, Maryland, United States
- Optimus Prosthetics — Dayton, Ohio, United States
- Ability P&O — Exton, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.