Feasibility Study to Evaluate a New Energy Storage and Return Prosthetic Foot

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-10

Study Completion Date

2022-03-11

Brief Summary

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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.

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Detailed Description

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The purpose of the Revo-M Study is to characterize differences in performance and patient reported outcomes between the Revo investigational prosthetic foot and a comparative prosthetic foot (Taleo or Proflex XC) when compared to the control foot which is the subject's currently used energy storage and return (ESR) prosthetic foot. The data obtained from this study may also serve to determine the long-term performance of Revo.

Conditions

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Lower Limb Amputation Below Knee (Injury) Lower Limb Amputation Above Knee (Injury) Lower Limb Amputation Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized cross-over controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Revo-M to Proflex XC

Transtibial amputees randomized to start with Revo-M and cross over to Proflex XC

Group Type EXPERIMENTAL

Revo-M

Intervention Type DEVICE

Investigational energy storage and return prosthetic foot with using novel elastic elements.

Proflex XC

Intervention Type DEVICE

Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects

Proflex XC to Revo-M

Transtibial amputees randomized to start with Proflex XC and cross over to Revo-M

Group Type EXPERIMENTAL

Revo-M

Intervention Type DEVICE

Investigational energy storage and return prosthetic foot with using novel elastic elements.

Proflex XC

Intervention Type DEVICE

Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects

Revo-M to Taleo

Transfemoral amputees randomized to start with Revo-M and cross over to Taleo

Group Type EXPERIMENTAL

Revo-M

Intervention Type DEVICE

Investigational energy storage and return prosthetic foot with using novel elastic elements.

Taleo

Intervention Type DEVICE

Commercially available carbon-fiber energy storage and return foot used as comparative foot for transfemoral amputee subjects

Taleo to Revo-M

Transfemoral amputees randomized to start with Taleo and cross over to Revo-M

Group Type EXPERIMENTAL

Revo-M

Intervention Type DEVICE

Investigational energy storage and return prosthetic foot with using novel elastic elements.

Taleo

Intervention Type DEVICE

Commercially available carbon-fiber energy storage and return foot used as comparative foot for transfemoral amputee subjects

Interventions

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Revo-M

Investigational energy storage and return prosthetic foot with using novel elastic elements.

Intervention Type DEVICE

Taleo

Commercially available carbon-fiber energy storage and return foot used as comparative foot for transfemoral amputee subjects

Intervention Type DEVICE

Proflex XC

Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Person is 18 years or older.
2. Currently uses an energy storage and return foot.
3. Person has been a unilateral transfemoral (TF), or transtibial (TT) amputee using a prosthesis for at least 1 year.
4. For TF amputees, the person must be wearing an Ottobock Microprocessor-controlled Knee (MPK) with a compatible prosthetic foot
5. Person weighs ≤ 275 lbs (125 kg) size 26-27cm or ≤ 220 lbs (100 kg) size 24-25cm
6. Person is a K3 ambulator based on Medicare Functional Classification Level (MFCL).
7. Prosthetic foot size is 24 to 27 centimeters.
8. Socket Comfort Score of at least 7
9. Ability to read and understand English
10. A person is able and willing to give consent

Exclusion Criteria

1. Current prosthetic foot is too old or worn out as assessed by the CPO.
2. TT subject with currently fit with a Proflex XC or TF subject currently fit with a Taleo.
3. Patient is pregnant or planning to become pregnant.
4. Person who has a life-threatening medical condition (i.e. terminal cancer, severe heart disease).
5. 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.).
6. Ulceration or skin breakdown of the residual limb.
7. Person currently has residual limb issues that significantly reduce their ability to load the prosthesis.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No