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

Otto Bock Healthcare (Ottobock)

Status: Completed

Conditions: Lower Limb Amputation Knee; Lower Limb Amputation Below Knee (Injury); Lower Limb Amputation Above Knee (Injury)

Treatments: Device: Taleo; Device: Revo-M; Device: Proflex XC

Study type: Interventional

Funder types: Industry

Identifiers

NCT04239222

OB111

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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27 participants in 4 patient groups

Revo-M to Proflex XC

Experimental group

Description:

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

Treatment:

Device: Proflex XC

Device: Revo-M

Proflex XC to Revo-M

Experimental group

Description:

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

Treatment:

Device: Proflex XC

Device: Revo-M

Revo-M to Taleo

Experimental group

Description:

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

Treatment:

Device: Revo-M

Device: Taleo

Taleo to Revo-M

Experimental group

Description:

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

Treatment:

Device: Revo-M

Device: Taleo