N/A
N=26
Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot
Lower Limb Amputation Below Knee (Injury) · Lower Limb Amputation Above Knee (Injury) · Lower Limb Amputation Knee
Bottom Line
View on ClinicalTrials.gov: NCT04239222 ↗Enrolled (actual)
26
Serious AEs
5.6%
Results posted
Sep 2024
Primary outcome: Primary: Patient-perceived Mobility (PLUS-M)™ — 57.2; 56.9; 58.3; 57.6 units on a scale — p=0.286
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Revo-M (Device); Taleo (Device); Proflex XC (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otto Bock Healthcare Products GmbH
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient-perceived Mobility (PLUS-M)™ |
57.2; 56.9; 58.3; 57.6 | 0.286 |
| PRIMARY Patient-perceived Activity Restrictions (Revised TAPES-AR Subscale) |
0.653; 0.686; 0.569; 0.674 | 0.031 sig |
| SECONDARY Percentage of Subjects Showing Improvement in Walking Endurance or Perceived Exertion in the 6-minute Walk Test |
11; 8; 10 | — |
| SECONDARY Patient Perceived Balance Confidence (ABC) |
86.8; 86.2; 87.7; 86.9 | 0.421 |
| SECONDARY Functional Satisfaction With Prosthesis (TAPES-FUN) |
21.6; 21.5; 22.1; 20.4 | 0.443 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04239222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.