Prospective, Feasibility Study to Evaluate Performance, Patient Benefits, and Acceptance of a New Energy Storage and Return Prosthetic Foot
Phase: NA
Conditions: Lower Limb Amputation Below Knee (Injury), Lower Limb Amputation Above Knee (Injury), Lower Limb Amputation Knee
Sponsor: Otto Bock Healthcare Products GmbH

 
 
Document Number 
PD-PR00011090Z-105 
NCT04239222    
Study ID 
OB111 
 
Creation Date: 
22-Jan-2020 
 
Author: 
Russ Lundstrom 
11501 Alterra Parkway, Suite 600 
Austin, TX 78758, USA 
Tel:  +1 512 806 2606 | Fax +1 512 806 2706 
e-mail:  russ.lundstrom@ottobock.com 
 
Revo-M Study 
Prospective, feasibility study to evaluate performance, patient benefits, and 
acceptance of a new energy storage and return prosthetic foot 
 
REVISION RECORD 
Date 
Version 
Description 
22-Jan-2020 
1.0 
Initial release 
 
Sponsor 
Otto Bock HealthCare LP 
 
11501 Alterra Parkway 
Suite 600 
Austin, TX 78758, USA 
Study Contact 
Russ Lundstrom 
11501 Alterra Parkway 
Suite 600 
Austin, TX 78758, USA 
Tel:  +1 512 806 2606 | Fax +1 512 806 2706 
e-mail:  russ.lundstrom@ottobock.com 
 
 

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Investigator’s Acknowledgement of Revo-M Study 
Name 
Revo-M Study 
Version 
1.0 
Investigational Site 
      
 
I acknowledge the study protocol indicated above and agree to conduct the study in accordance with 
it. 
 
Acknowledged by: 
Printed Name 
Signature 
Date 
 
 
 
 
 
 
 

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Sponsor Approvals of Revo-M Study 
Sponsor 
Otto Bock HealthCare LP 
Name & Document 
Number 
Revo-M Study 
Version 
1.0 
 
I acknowledge the study protocol indicated above and agree to oversee the conduct of this study in 
accordance with it. 
 
Acknowledged by: 
 
 
Signature 
Date 
Sponsor 
Russ Lundstrom 
 
 
Director of Clinical and 
Field Clinical Services – 
North America 
 
 
 

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Table of Contents 
Clinical Study Summary ................................................................................................................................ 6 
List of Abbreviations and Definition of Terms ............................................................................................... 7 
Background and Rationale ............................................................................................................................ 8 
Study Devices ............................................................................................................................................... 9 
Ottobock Investigational Study Device (Revo-M) ................................................................................... 9 
Manufacturer .................................................................................................................................................... 9 
Model number, Version .................................................................................................................................. 10 
Intended Use ................................................................................................................................................. 10 
Technical Description..................................................................................................................................... 10 
Comparative Study Devices (Taleo and ProFlex XC) .......................................................................... 10 
Study Device Technical Specifications ................................................................................................. 11 
Regulatory Classification ...................................................................................................................... 11 
Purpose ....................................................................................................................................................... 11 
Protocol ....................................................................................................................................................... 12 
Study Summary .................................................................................................................................... 12 
Objectives ............................................................................................................................................. 14 
Safety............................................................................................................................................................. 14 
Effectiveness ................................................................................................................................................. 14 
Eligibility Criteria ................................................................................................................................... 15 
Patient Population................................................................................................................................. 16 
Vulnerable Subjects .............................................................................................................................. 16 
Study Procedures ................................................................................................................................. 16 
Informed Consent .......................................................................................................................................... 16 
Data collection ............................................................................................................................................... 16 
Enrollment ...................................................................................................................................................... 17 
Randomization ............................................................................................................................................... 17 
Fitting process for the Revo-M investigational foot ........................................................................................ 17 
Fitting process for the comparative feet: Taleo and ProFlex XC .................................................................... 17 
Clinical Tests & Measures ............................................................................................................................. 17 
Study-specific Questionnaires ....................................................................................................................... 19 
Training Requirements ......................................................................................................................... 20 
Adverse Events..................................................................................................................................... 21 
Adverse Event Definition ................................................................................................................................ 21 
Adverse Event Reporting ............................................................................................................................... 21 
Adverse Event Adjudication ........................................................................................................................... 21 

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Serious Adverse Event .................................................................................................................................. 21 
Relatedness ................................................................................................................................................... 21 
Severity Rating .............................................................................................................................................. 22 
Statistical Considerations and Data Analysis .............................................................................................. 22 
Sample Size .......................................................................................................................................... 22 
Hypothesis ............................................................................................................................................ 23 
Time Period .......................................................................................................................................... 26 
Data Analysis ........................................................................................................................................ 26 
Risk-Benefit Analysis .................................................................................................................................. 26 
Risks and Minimization of Risks ........................................................................................................... 26 
Benefits ................................................................................................................................................. 27 
Study Management ..................................................................................................................................... 28 
Sponsor Responsibilities ...................................................................................................................... 28 
Investigator Responsibilities ................................................................................................................. 28 
Records and Reports ............................................................................................................................ 28 
Investigator Reports ....................................................................................................................................... 29 
Sponsor Records ........................................................................................................................................... 29 
Sponsor Reports ............................................................................................................................................ 30 
Monitoring procedures .......................................................................................................................... 30 
Study monitors ............................................................................................................................................... 30 
Site Visits ....................................................................................................................................................... 30 
Monitoring Reports ........................................................................................................................................ 31 
Study Discontinuation or Termination................................................................................................... 31 
Investigational Site Termination ..................................................................................................................... 31 
Premature Discontinuation of the study ......................................................................................................... 31 
Ethical Statement.................................................................................................................................. 31 
Institutional Review Board (IRB) .................................................................................................................... 31 
Ethical conduct of the study ........................................................................................................................... 32 
Disclosure of data and publication policy ............................................................................................. 32 
Disclosure of data .......................................................................................................................................... 32 
Publication policy ........................................................................................................................................... 32 
Contact information .............................................................................................................................. 33 
Contracts, finances ..................................................................................................................................... 33 
Bibliography ................................................................................................................................................ 34 

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Clinical Study Summary 
Title 
Prospective, feasibility study to evaluate performance, patient benefits, and 
acceptance of a new energy storage and return prosthetic foot 
Purpose 
To characterize differences in performance and patient reported outcomes 
between the Taleo, Proflex XC, and the new Revo prosthetic foot. 
Design 
A prospective, interventional, multicenter pilot study 
Co-Sponsors 
Ottobock SE & Co. KGaA (Germany) 
Otto Bock HealthCare LP (United States) 
Control 
Current Energy Storing and Return prosthetic foot 
Study Devices 
Revo-M, Taleo, and ProFlex XC prosthetic feet 
Enrollment 
Up to 30 K3 subjects; at least 12 transtibial and 12 transfemoral  
Clinical Sites 
Up to 5 sites in the United States 
Primary Safety  
Objective 
To characterize all device-related adverse events, stumbles, and falls 
experienced by subjects in the study by frequency and severity. 
Primary Efficacy 
Objectives 
1. To characterize perception of mobility as measured by the PLUS-M while 
wearing the Revo-M compared to the everyday feet. 
2. To characterize the level of activity restrictions as measured by the Trinity 
Amputation and Prosthesis Experience Scales Activity Restrictions 
subscale (TAPES-AR) while wearing the Revo-M compared to the 
everyday feet. 
Secondary Efficacy 
Objectives 
1. To characterize the level of walking endurance as measured by the 
distance walked in the six minute walk test and the perceived exertion 
measured by Borg CR100 while wearing the Revo-M compared to the 
everyday feet. 
2. To characterize the perception of balance confidence as measured by 
the extended Activities-specific Balance Confidence (ABC) Scale while 
wearing the Revo-M compared to the everyday feet. 
3. To characterize the level of functional satisfaction as measured by the 
TAPES Functional Satisfaction (TAPES-FUN) subscale while wearing the 
Revo-M compared to the everyday feet. 

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Exploratory Objective 
1. To characterize the outcome measures described in the primary and 
secondary objectives while wearing the Revo-M compared to the 
comparative feet (Taleo/ProFlex XC). 
2. To characterize perception of quality of life as measured by the EQ-5D-
5L while wearing the Revo-M compared to the everyday feet and the 
comparative feet. 
3. To characterize the level of fatigue as measured by the PROMIS Fatigue 
Short Form 7a while wearing the Revo-M compared to the everyday feet 
and the comparative feet. 
4. To characterize activity level as measured by steps per day and cadence 
recorded by a StepWatchTM activity monitor while wearing the Revo-M 
compared to the everyday feet and the comparative feet. 
5. To characterize the Physiologic Cost Index of walking as measured 
during the 6-minute Walk Test while wearing the Revo-M compared to 
the everyday feet and the comparative feet. 
6. To characterize the perception of pain interference as measured by the 
PROMIS Pain Interference short form 4a collected from the patient 
journal while wearing the Revo-M compared to the everyday feet and the 
comparative feet. 
Estimated Timeline 
Estimated study start/first subject in 
Period II start/fitting with 1st study foot 
Period III start/cross-over to 2nd study foot 
Period IV start/cross-over to control foot 
Last patient out 
February 2020 
April 2020 
June 2020 
August 2020 
December 2020 
List of Abbreviations and Definition of Terms 
AE 
Adverse Event 
ABC 
Activity-based Balance Confidence 
CPO 
Certified Prosthetist Orthotist 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
K3 
K-level 3 or Medicare Functional Classification Level 3. 
Has the ability or potential for ambulation with variable cadence. 
Typical of the community ambulator who has the ability to traverse 
most environmental barriers and may have vocational, therapeutic, or 
exercise activity that demands prosthetic utilization beyond simple 
locomotion. 
KD 
Knee Disarticulation 
IRB 
Ethics Committee or Institutional Review Board 

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MFCL 
Medicare Functional Classification Level 
PCI 
Physiological Cost Index 
PLUS-M 
Prosthetic Limb User Survey of Mobility 
PROMIS 
Patient Reported Outcomes Measurement Information System 
SAE 
Serious Adverse Event 
Sponsor 
The institution funding and responsible for the total clinical 
investigation, in this case Otto Bock HealthCare LP (US) 
TAPES-AR 
Activity Restriction domain of the Trinity Amputation and Prosthesis 
Experiences Scales 
TAPES-FUN 
Functional subscale in the Satisfaction domain of the Trinity 
Amputation and Prosthesis Experiences Scales 
TT 
Transtibial 
TF 
Transfemoral 
Background and Rationale 
Prosthetic feet are modular components that are designed to replace the function of the ankle-foot 
complex after losing a part of the lower limb. An individualized selection of the prosthetic foot is of 
utmost importance with regard to the successful prosthetic treatment of an amputee. Ideally, the 
design and function of the prosthetic leg leads to the lowest level of joint overload regardless of 
amputation level in order to prevent long-term damage. The selection of the prosthetic foot is 
decisive for both the static and dynamic behavior of a prosthesis. Depending on the condition and 
mobility of the patient, there are a large number of prosthetic feet that are suitable for certain 
activities. 
Prosthetic energy-storage-and-release (ESR) feet are designed to store energy during early stance 
phase and then release a portion of that energy late in stance phase. To date, they are state of the art 
for lower limb amputees. This is especially true for higher mobility grade amputees [Baumgartner, 
2009]. Nevertheless, these feet also provide many benefits for lower mobility patients [Kraft, 2015].  
The prosthetic heel is the primary area of impact loading in the prosthesis. As the foot contacts the 
ground, the heel is loaded in compression and unloaded slowly as the amputee moves into mid-
stance and keel loading begins (Figure 1). Some ESR feet have a heel that consists of a compressible 
foam material and this simulates controlled plantarflexion as it compresses and brings the forefoot 
into contact with the ground. The foam heel uses a viscoelastic material that dissipates energy as it 
compresses and expands. Other types of ESR feet utilize a heel spring that is typically made from 
carbon fiber or a similar material. This spring acts like the compressible foam with regards to 
simulated plantarflexion during loading of the limb, but with much greater energy-storage and 
energy-return capability. The heel initially compresses and then releases energy as the foot moves 
into mid-stance. Thus, for this design, the heel is an important energy-storage and energy-return part 
of the prosthesis. As the stiffness of the heel increases, the extent of the impact absorption 
decreases and less energy is dissipated. However, in ESR feet with a flexible keel, the keel begins to 

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deflect as the person moves into midstance and energy is stored as the foot dorsiflexes. As this tibial 
advancement occurs, the keel spring is deflected and energy is stored until the amputee nears the 
end of stance phase and begins unloading the prosthesis. As the foot is unloaded in terminal stance, 
the keel spring returns a portion of the stored energy and assists in propelling the limb forward into 
pre-swing (Figure 1). [Hafner, 2002] 
 
Figure 1 Principles of ESR feet, modified from Hafner et al. [Hafner, 2002] 
The elastic behavior of ESR feet may negatively influence the stability and comfort of standing and 
walking. In addition, it is important that the energy is returned at the right moment; otherwise, it will 
disrupt rather than support locomotion. Therefore, a high number of parameters have to be 
considered during the development of an ESR foot. Many of them can be determined with 
computer simulations, but not all. It is possible that the user will reject a prosthetic foot that 
perfectly meets their criteria according to the simulation. Therefore, it is necessary during 
development to evaluate these feet under close to daily-use conditions.  
Ottobock is currently developing a new prosthetic foot, the Revo-M, which should be better 
adapted to the needs of the moderately active users. In particular, it should provide better energy 
management by optimizing the timing and amount of energy returned. It should also adapt to 
varying ground conditions.  
Study Devices 
Ottobock Investigational Study Device (Revo-M) 
Manufacturer 
Ottobock SE & Co. KGaA 
Max-Näder-Straße 15, 37115 Duderstadt 

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Model number, Version 
Product Name 
Version 
Revo-M 
FM2.0 
Intended Use 
The Revo-M foot is intended for exoskeletal fitting of lower limb amputees. It is intended for 
moderate to high-activity level amputees (MFCL grade 2, 3 or 4). 
Technical Description 
The Revo-M prosthetic foot belongs to the group of energy-storage-and-release (abbrev: ESR) feet. 
It utilizes carbon springs and polyurethane-foam bumpers as elastic elements. These elastic elements 
allow for a harmonic rollover during stance phase. The proximal connection to other prosthetic 
components is provided by the aluminum upper part, which contains a pyramid adaptor for this 
purpose. Furthermore, there is a pivoting joint at the center of the foot within the aluminum upper 
part that combines with a tension element in the heel region to form a connection to the elastic 
elements of the foot.  
 
Figure 2 CAD-rendered image of Revo-M without foot shell 
Comparative Study Devices (Taleo and ProFlex XC) 
Two commercially available comparative study devices will also be assessed in the study, the Taleo 
and the ProFlex XC. The comparative foot for transfemoral subjects will be the Taleo manufactured 
by Ottobock. The comparative foot for transtibial subjects will be the ProFlex XC manufactured by 
Össur. 

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Figure 3 Comparative Study Devices, Taleo (left) and ProFlex XC (right) 
Study Device Technical Specifications 
Table 1 Technical Specifications for the Three Study Devices 
Specification 
Revo-M 
(Investigational) 
ProFlex XC 
(Comparative TT) 
Taleo 
(Comparative TF) 
Activity Levels 
K2, K3 and K4 
K3 and K4 
K3 
Max Body Weight  
Size 26: 275 lbs (125 kg) 
Size 24: 220 lbs (100 kg) 
365 lbs (165 kg) 
330 lbs (150 kg) 
Heel Height  
Size 26: 10 mm 
Size 24: 20 mm 
10 mm 
Normal footshell (N) 10 
+/- 5mm, Slim footshell 
(S) 15 +/- 5 mm 
Footshell shape  
Size 26: Normal Size 24: 
Slim  
Normal 
Normal (N), Slim (S) 
Min. Clearance Height  
Size 26: 112.5 mm (4 7/16") 
Size 24: 110 mm (4 1/3")  
155 mm (6 1/8 “) 
158 mm (6 1/4") 
Sizes  
24, 26 cm 
22-24, 25-27, 
28-30 cm 
22 - 30 cm 
Regulatory Classification 
All study devices are Class I devices 
FDA Registration under Device Listing Regulation number 890.3420 product code ISH. 
Purpose 
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 
evaluate the long-term performance of Revo. 

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Protocol 
Study Summary 
Period I 
The study is planned to be divided into four periods as illustrated in Figure 4. The only clinical 
measures to occur from the beginning of Period I are the StepWatch, Patient Journal, and Socket 
Comfort Score. After enrollment, the subject will spend 8 weeks (+/-2 weeks) using their own 
energy storage and return foot. Informed consent, demographic information, general health 
information, and adverse events will be collected during this period. After enrollment, the subject 
will be randomized to Revo, Taleo (if a transfemoral amputee), or the Proflex XC (if a transtibial 
amputee). 
Period II – Period IV 
Baseline measures are taken just prior to Period II. After the first 8 week follow up, the subject will 
crossover to the second comparator. After the second 8 week follow up, the subject will crossover 
to control. During Period IV, assessments will be repeated as in baseline. Table 2 summarizes the 
assessments and order of events. 
 
Visit 1 
Enrollment 
Fit with StepWatch 
Given Journal 
Visit 2 
Baseline Assessments 
Initial study foot fitting  
(for Period II) 
Visit 3 
Initial Assessments 
Cross-over fitting  
(for Period III) 
Visit 4 
Crossover Assessments 
Fitting to Everyday Foot 
(for Period IV) 
Visit 5 
Period IV assessments 
End of Study 
Figure 4 Study Periods and Visits 
 

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Table 2 Assessments by Period and Study Visit 
Period I 
(Control) 
Period II 
(Revo/ 
Comparative) 
Period III 
(Revo/ 
Comparative) 
Period IV 
(Control) 
 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Visit 5 
Measurement 
Enrollment 
Baseline 
8 ± 2 weeks  
Period II Follow up  
8 ± 2 weeks 
Period III Follow up 
8 ± 2 weeks 
Period IV Follow
8 ± 2 weeks
Demographics /  
General Health 
X 
 
 
 
 
SCS 
X 
X 
X 
X 
X 
ABC (extended) 
 
X 
X 
X 
X 
PLUS-M 
 
X 
X 
X 
X 
PROMIS-F (7a) 
 
X 
X 
X 
X 
TAPES-FUN + TAPES-AR 
 
X 
X 
X 
X 
EQ-5D-5L  
 
X 
X 
X 
X 
6 Minute Walk Test (incl. BORG 
RPE and continuous HR) 
 
X 
X 
X 
X 
Foot Preference Questionnaire 
 
 
 
 
X 
Patient Journal (incl. Pain 
Interference) 
X 
X 
X 
X 
X 
Step Count* 
X 
X 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
Fitting with prosthetic foot 
for subsequent Period 
 
X 
X 
X 
 
* Subject is fitted with StepWatch at previous visit so that the data may be collected prior to the following visit, this process starts at enrollment 
 

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Objectives 
Safety 
Safety Objectives 
1. To characterize all device-related adverse events, stumbles, and falls experienced by subjects 
in the study by frequency and severity. 
Effectiveness 
Primary Efficacy Objectives 
1. To characterize perception of mobility as measured by the PLUS-M while wearing the Revo-
M compared to the everyday feet. 
2. To characterize the level of activity restrictions as measured by the Trinity Amputation and 
Prosthesis Experience Scales Activity Restrictions subscale (TAPES-AR) while wearing the 
Revo-M compared to the everyday feet. 
Secondary Efficacy Objectives 
1. To characterize the level of walking endurance as measured by the distance walked in the six 
minute walk test and the perceived exertion measured by Borg CR100 while wearing the 
Revo-M compared to the everyday feet. 
2. To characterize the perception of balance confidence as measured by the extended 
Activities-specific Balance Confidence (ABC) Scale while wearing the Revo-M compared to 
the everyday feet. 
3. To characterize the level of functional satisfaction as measured by the TAPES Functional 
Satisfaction (TAPES-FUN) subscale while wearing the Revo-M compared to the everyday 
feet. 
Exploratory Objectives 
1. To characterize the outcome measures described in the primary and secondary objectives 
while wearing the Revo-M compared to the comparative feet (Taleo/ProFlex XC). 
2. To characterize perception of quality of life as measured by the EQ-5D-5L while wearing 
the Revo-M compared to the everyday feet and the comparative feet. 
3. To characterize the level of fatigue as measured by the PROMIS Fatigue Short Form 7a 
while wearing the Revo-M compared to the everyday feet and the comparative feet. 
4. To characterize activity level as measured by steps per day and cadence recorded by a 
StepWatchTM activity monitor while wearing the Revo-M compared to the everyday feet and 
the comparative feet. 
5. To characterize the Physiologic Cost Index of walking as measured during the 6-minute 
Walk Test while wearing the Revo-M compared to the everyday feet and the comparative 
feet. 

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6. To characterize the perception of pain interference as measured by the PROMIS Pain 
Interference short form 4a collected from the patient journal while wearing the Revo-M 
compared to the everyday feet and the comparative feet. 
 
Eligibility Criteria 
Patients must meet all of the below mentioned inclusion criteria and none of the exclusion criteria to 
be eligible to participate in the study.  
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. 

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Patient Population 
Up to 30 existing prosthetic foot users will be enrolled in the study. At least 12 of the subjects will 
be transfemoral (TF) or knee disarticulation (KD) amputees and at least 12 will be transtibial 
amputees (TT). There is no exclusion with regards to the cause of amputation (e.g. whether 
traumatic, cancer or dysvascular). 
Vulnerable Subjects 
Only adults between the ages of 18 and 75 will be enrolled in the study. No minors may take part in 
this study. Women of childbearing age who are currently pregnant or who are planning to become 
pregnant during the time of the study, may not be enrolled in this study.  
Study Procedures 
Informed Consent 
The Investigator is responsible for ensuring that data collection does not take place before the 
patient and/or legal guardian has given informed consent. Written consent must be given by the 
patient after the receipt of detailed information. The verbal explanation will cover all the elements 
specified in the written information provided for the patient.  
The Investigator will inform the patient of the aims and methods of the study. The patient must be 
given every opportunity to clarify any points he/she does not understand and if necessary, ask for 
more information. At the end of the interview the patient may be given time to reflect if this is 
required, or more time for discussion with family, caregivers or their own General Practitioner. 
Patients and/or legal guardians will be required to sign and date the informed consent form. After 
completion, informed consent forms will be kept and archived by the Investigator in the Study File, 
and a copy given to the patient.  
Prior to the beginning of the study, the Investigator will provide the Sponsor with a copy of the 
sample informed consent form approved by the IRB and evidence that the IRB has approved the 
study. The Sponsor must approve any changes to the informed consent form template.  
It should be emphasized that the patient is at liberty to withdraw their consent to participate at any 
time, without penalty, loss of benefits or normal medical care to which the patient is otherwise 
entitled. Patients who refuse to give, or withdraw written informed consent will not be included or 
continue in this study.  
Data collection 
Data will be collected and entered by the Investigator in the form of electronic Case Report Forms 
(eCRFs) into an Electronic Data Capture (EDC) system by means of prospective data collection.  
The following eCRFs are planned to be used for prospective data collection at participating sites: 
1. Enrollment 
2. Baseline 
3. Follow-up 
4. Patient Journal 

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5. Adverse Event 
6. Study Termination 
Enrollment  
After a patient has signed the written Informed Consent Form and meets the inclusion-exclusion 
criteria, the patient will be considered enrolled in the study. At this point, demographic data, medical 
history (including fall history) will be collected. 
Alignment Assessment 
All subjects will undergo an assessment of alignment by the CPO with their current ESR foot. 
Minor changes to the alignment may be done if the CPO deems it necessary. 
Baseline Testing 
Baseline testing with the patient’s current ESR foot will be conducted at the end of Period I and will 
include four questionnaires, the PLUS-M, EQ-5D-5L, PROMIS Pain Interference short form, and 
the extended Activity-specific Balance Confidence Scale. One performance measure will be 
conducted, the six-minute walk test (see Clinical Tests & Measuresfor test descriptions). 
Randomization 
The fittings during Period II and Period III are determined at random and according to amputation 
level. Subjects will be randomized to start with either the Revo (regardless of amputation level) or 
the comparative foot:  Taleo if TF or KD, Proflex XC if TT. After completing Period II with the 
assigned foot, subjects will cross over to be fit with either the Revo, if starting with the comparative 
foot or the comparative foot if starting with the Revo. 
Fitting process for the Revo-M investigational foot 
The Revo prosthetic foot has several components which have different mechanical characteristics to 
allow the foot to be tailored to the patient. Subjects will complete several walking trials to determine 
the optimal configuration.  
Fitting process for the comparative feet: Taleo and ProFlex XC 
The Taleo is customizable with heel wedges that come in three different stiffnesses (soft, medium 
and hard). The CPO may give the subjects the opportunity to try each wedge to determine which is 
best. 
ProFlex XC does not have any customizable components, so no configuration process is required. 
Home-use Periods 
Subjects will have four home-use periods during the study approximately 8 weeks in duration as 
shown in Figure 4 above. Prior to each home-use period, subjects will be fitted with the assigned 
foot and be given a Patient Journal and a StepWatch activity monitor. The Patient Journals will be 
completed weekly for the duration of the home-use period. The StepWatch will be worn for 
approximately one month and then mailed back to the clinical site. At the end of the home-use 
period, subjects will return to the site for a follow-up visit for assessments (see Clinical Tests & 
Measures for test descriptions).  

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Clinical Tests & Measures 
Data collection for the following clinical functional assessments will be collected on eCRFs. Several 
questionnaires and two performance based measures will be used in the study. 
For an overview of the assessments required by visit, see Table 2. 
Activity monitoring (daily step counts) 
The StepWatch will be used for activity monitoring to collect daily step counts during the first 
month of each home-use period. 
Six-minute walk test (6minWT) 
The six-minute walk test is performed as an objective evaluation of functional exercise capacity. The 
six-minute walk test is easy to administer, well tolerated, and typically reflective of activities of daily 
living. The test measures the distance that the patient can walk on a flat, hard surface, indoors, in a 
period of six minutes. The walk test is patient self-paced and assesses the level of functional 
capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If 
the patient is unable to complete the time, the time stopped is noted and the reason for stopping 
prematurely is recorded. When administering the six-minute walk test, the recommendations of the 
American Thoracic Society will be followed (ATS Statement, 2002), which requires systolic blood 
pressure to be below 180 mm Hg and heart rate to be below 120 bpm prior to the test. 
Before and immediately after the test, the Borg Rating of Perceived Exertion (RPE) using the 
CR100 (centiMax) scale (Borg 2002) will be measured.  
Prior to the test, all subjects will wear a heart rate strap, and after the test the recorded heart rate will 
be collected. 
Trinity Amputation and Prosthesis Experience Scales (TAPES) 
The TAPES is a quality of life measure with nine subscales that broadly fall into three domains: 
Psychosocial, Activity Restriction, and Satisfaction with the prosthesis (Gallagher et al, 2010). The 
three subscales of the Activity Restriction domain are referred to as TAPES-AR and the functional 
subscale of the Satisfaction domain is referred to as TAPES-FUN. Only the TAPES-AR domain 
and TAPES-FUN subscale are used in this protocol. 
PROMIS Fatigue Short Form 7a 
PROMIS item banks and their short forms are a reliable and precise measurements of patient 
reported outcome measures (Cella, 2005-2008). The PROMIS Fatigue item banks assess a range of 
self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, 
and sustained sense of exhaustion that likely decreases one’s ability to execute daily activities and 
function normally in family or social roles. Fatigue is divided into the experience of fatigue 
(frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social 
activities. The fatigue short forms are universal rather than disease-specific. All assess fatigue over 
the past seven days.  
The original adult short form (7a) was constructed by the domain team with a focus on representing 
the range of the trait and also representing the content of the item bank. Domain experts reviewed 
short forms to give input on the relevance of each item. Each domain group worked independently 

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and the original short forms are 6-10 items long depending on the domain. Psychometric properties 
and clinical input were both used and likely varied in importance across domains. 
 
Extended Activities-Specific Balance Confidence (ABC) Scale 
The ABC Scale (Lajoie 2004) is a self-administered questionnaire that asks the patient to rate his or 
her confidence in performing various ambulatory activities on a scale from 0% (no confidence) to 
100% (complete confidence) without losing balance or becoming unsteady. Scores for each of the 16 
items will be collected and an average percentage calculated, with scores <67 indicating an increased 
risk of falling (Miller et al., 2003/2004). 
5 items of interest were added to gauge the impact of the reported increase in proprioception in 
earlier models of the Revo-M on balance confidence. 
This test was selected since it measures patient perceived balance confidence, and is expected to help 
assess the impact of the new foot. 
Prosthetic Limb Users Survey-M (PLUS-M) 
The PLUS-M is a valid and reliable self-reported measure for the mobility of adults with lower limb 
amputations. PLUS-M asks about the subject’s ability to perform simple and complex tasks. This 
questionnaire asks about the current timeframe for the patient. High PLUS-M scores correspond 
with greater mobility (Hafner et al., 2016). 
EQ-5D-5L 
The EQ-5D-5L is a standardized measure of health status developed by the EuroQol group, 
applicable to a wide range of health conditions and treatments. It has widespread currency outside 
the profession. It is often referred to as a quality of life questionnaire. 
The EQ-5D-5L, is a very simple measure which subjects complete at the start and end of treatment. 
Its name means 'EuroQol – 5 Dimensions – 5 Levels' and comprises five dimensions of health: 
mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, and anxiety 
and depression. There are five options (levels) under each domain. Index scores will be computed 
whereby higher scores indicate higher quality of life. 
PROMIS Pain Interference 
The PROMIS Pain Interference – Short Form 4a has been incorporated into the patient journal. 
The patient will be asked six questions related to how pain may have interfered with certain activities 
in the last 7 days, and rate them on a 1-5 scale, with ‘1’ being ‘not at all’ and ‘5’ being ‘very much.’  
Study-specific Questionnaires 
Subject Study-specific Questionnaire (Subject SSQ) 
Questions have been developed to assess the end users’ preferences regarding the three prosthetic 
feet. 

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Patient Journal 
Subjects will be provided with a ‘journal’ to answer a questionnaire once per week during the 
accommodation period while wearing the current ESR foot and during home use while wearing the 
study devices. The weekly questionnaire in the journal will including questions about satisfaction 
with the prosthesis, positive and negative observations about prosthetic performance, medical issues, 
the use of pain medication and the PROMIS Pain Interference short form. The journals will be 
completed online using links that will be provided to subjects. In the case that a subject does not 
have easy access to the internet, paper journals will be provided. The journals will be reviewed 
together with the Investigator during in-person visits. In addition, subjects will also record in the 
journal any falls and resulting injuries.  If any of the journal entries reveal complaints or adverse 
events, these will be reported on the Adverse Event form. 
Training Requirements 
The Investigator and investigational site personnel will be given training on the study requirements 
and an overview of the study devices prior to data collection for study patients. Training on the 
study requirements will include Investigator responsibilities and requirements, review of the study 
data collection protocol, review of the Electronic Data Capture (EDC) system with the paper and 
eCRF’s, and study administration. The Investigator will also be responsible for completing Human 
Subject Protection Training that meets their IRB requirements at the initial review submission, if not 
already completed. In addition, the Investigator will be responsible for ensuring their certification, if 
required by the IRB, is current throughout the lifetime of the study, and will submit to the Sponsor a 
copy of the current certification each time it is renewed.   
All training will be documented using training records including the elements of training completed, 
the trainers that delivered the training and the signatures of the participants. Site initiation visits or 
conference calls may be made by a Sponsor-appointed Monitor to review the Study Protocol and 
documentation requirements with the Investigator and clinic support staff involved in the study. The 
Sponsor will then determine if additional center-specific training is needed and will ensure that all 
researchers involved in the project have adequate training. Study activities may only be performed 
once the Sponsor confirms activation of the investigational site.  
In addition to training, at a minimum, the following documentation must be in place at the 
investigational site before patient enrollment begins: 
x Current Investigator’s and Sub-Investigator’s CVs 
x Signed study agreement 
x Completed training in human research subject protection or an overview of Good Clinical 
Practice if required by the IRB. 
x IRB approval letter for the Study Protocol and amendment(s) 
x Patient Informed Consent approved by both the IRB and Otto Bock Healthcare Products 
GmbH 

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Adverse Events 
Adverse Event Definition 
An adverse event is any untoward medical occurrence in a patient.  An underlying disease or 
symptoms associated with the underlying disease that were present prior to the fitting of study 
devices are not reportable. However, any increase in severity of the underlying disease or symptoms 
since a study fitting is to be reported as an adverse event. If an adverse event leads to multiple 
outcomes that sequentially worsen during the course of the study, the worst event is reported. For 
example, skin irritation leading to a wound infection would be reported as infection. 
Adverse Event Reporting 
Once a subject is enrolled, all adverse events must be reported until the subject is withdrawn or is 
terminated from the study. 
Adverse Event Adjudication 
Events will be adjudicated per the definitions below. 
Serious Adverse Event 
A Serious Adverse Event (SAE) is an Adverse Event that: 
1. led to a death; 
2. led to a serious deterioration in the health of the patient that 
x results in a life-threatening illness or injury; 
x results in a permanent impairment of a body structure or a body function; 
x requires hospitalization or prolongation of existing hospitalization; 
x results in medical or surgical intervention to prevent permanent impairment to body 
structure or a body function; or  
3. led to fetal distress, fetal death or a congenital abnormality or birth defect. 
Relatedness 
Each adverse event will be assessed regarding relatedness to the study device or the fitting 
procedure. In addition, the level of relatedness will be classified according to definitions as presented 
in Table 3. 

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Table 3  Rating the Relatedness of Adverse Events 
Relatedness: 
Description: 
Highly 
Probable 
The adverse event follows a reasonable temporal sequence from 
receipt (or attempted receipt) of the device treatment or procedure.   
Probable 
The adverse event follows a reasonable temporal sequence from 
receipt of the device treatment or procedure and the possibilities of 
factors other than the device treatment or procedure, such as 
underlying disease, concomitant drugs, or concurrent treatment can 
be excluded. 
Possible 
The adverse event follows a reasonable temporal sequence from 
receipt of the device treatment or procedure and the possibility of 
device treatment or procedure involvement cannot be excluded.  
However, other factors such as underlying disease, concomitant 
medications, or concurrent treatment are presumable. 
Unlikely 
The adverse event has an improbably temporal sequence from 
receipt of the device treatment or procedure, or it can be reasonably 
explained by other factors, including underlying disease, 
concomitant medication, or concurrent treatment. 
Not Related 
The adverse event has no temporal sequence from receipt of the 
device treatment or procedure, or it can be explained by other 
factors, including underlying disease, concomitant medication, or 
concurrent treatment. 
Severity Rating 
The severity of adverse events will be classified according to definitions as presented in Table 4. 
Table 4 Rating of the Severity of Adverse Events 
Severity: 
Description: 
Mild 
Usually transient, requiring no special treatment, does not interfere with the patient’s 
daily activities. 
Moderate 
Low-level inconvenience or concern to the patient, may interfere with daily activities, 
usually resolved by simple therapeutic non-interventional methods. 
Severe 
Interruption in patient’s daily activity requiring systemic drug therapy or other 
treatment. 
Statistical Considerations and Data Analysis 
Sample Size 
The sample size for the study will be a minimum of 24 existing ESR users. A sample size of 22 subjects 
is required to provide 80% power to detect a difference of 5 points on the PLUS-M scale using 
Wilcoxon’s matched pairs signed ranks test and alpha of 0.05. A standard deviation of 7.7 was used to 
calculate the sample size. The TAPES-AR endpoint requires 21 subjects to achieve the same level of 

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power using a difference of 0.2 and standard deviation of 0.3. The maximum number of subjects 
allowed in the feasibility study was increased to 30 to allow for early study exit and/or missing data. 
Interim analysis and adaptive study design 
This investigation will make use of an adaptive study design. An interim analysis will be performed 
after all eligible patients (n=24) have completed the second study period (Period II). After the 
interim analysis, it will be decided whether (1) the assumptions regarding expected observed 
differences and standard deviations for the primary objectives are confirmed, (2) adjustments must 
be made in the sample size to ensure 80% power to achieve the study objectives or (3) the study 
must be terminated for futility. The interim analysis will be performed by an independent statistician. 
Review of the results and a decision on the different options will determined by the Sponsor. 
It is the intention of the Sponsor that this study would be a part of an adaptive, seamless study 
design in which, in the case that the feasibility study successfully achieves the primary objectives, a 
pivotal trial may follow with an increase in enrollment to allow for adequate statistical power to 
address both primary and secondary objectives. The final analysis of the pivotal trial would use data 
from subjects enrolled before and after the adaptation. Sample size calculations for the pivotal trial 
would be based on observed differences and standard deviations in outcomes measures from the 
feasibility study. 
Hypothesis 
It is expected that subjects will demonstrate better outcomes on primary and secondary endpoint 
measures with the Revo-M compared to their everyday feet. 
Outcome measures obtained after using the Revo-M foot for 8 weeks will be compared to baseline 
measures obtained using everyday feet with a 2-sided Wilcoxon matched pairs signed ranks test. The 
Hochberg method will be used to adjust alpha for the multiple primary effectiveness endpoints, 
thereby limiting the family-wise alpha to 0.05. In this method, p-values are ranked from highest to 
lowest for each primary endpoint tested. If the highest p-value is ≤ 0.05, all null hypotheses will be 
rejected and no further adjustment will be made. If, however, the highest p-value is > 0.05, alpha 
will be adjusted to 0.025 (alpha/2). The remaining p-value must be ≤ 0.025 in order to be 
statistically significant. Adjustment of alpha will continue in this manner for all primary effectiveness 
endpoints. Two-tailed p-values ≤ the Hochberg adjusted alpha will indicate statistical significance. 
Primary efficacy endpoints (2 endpoints) will be considered one family and secondary efficacy 
endpoints (3 endpoints) will be considered a second separate family. The Hochberg method will not 
be applied to exploratory endpoints. 
If the observed p-value is ≤ the Hochberg adjusted critical value, the difference will be regarded as 
statistically significant. Because this is a randomized crossover study, the Revo-M may be either the 
first or second new foot used after baseline measures with the everyday feet. It is important to assess 
whether differences between Revo-M and everyday feet scores are influenced by the order in which 
the new feet are assigned. To evaluate this a difference score will be computed by subtracting 
everyday feet scores from Revo-M scores. Difference scores for subjects receiving the Revo-M foot 
first will be compared to those of subjects who received the Revo-M foot second (after a 
comparative foot) using Wilcoxon’s rank sum test. A resulting p-value ≤ 0.05 will indicate that 
differences in the specified outcome measure may depend on the order in which the Revo-M was 

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assigned and not simply due to the Revo-M itself. Interpretation of differences between Revo-M and 
everyday feet scores will be modified accordingly. 
Primary Efficacy Endpoints 
Primary Efficacy Endpoint #1: Perception of mobility as measured by the PLUS-M. It is hypothesized 
that PLUS-M scores will be higher for subjects when they are using the Revo-M compared to their 
everyday feet. In statistical terms the null and alternative hypotheses are as follows: 
HO: μRevo-M ≤ μEveryday 
HA: μRevo-M > μEveryday 
Where HO  is the null hypothesis, μRevo-M is the mean PLUS-M score using the Revo-M, μEveryday is the 
mean PLUS-M score using the everyday feet and HA is the alternative hypothesis indicating that 
perception of mobility as measured by the PLUS-M is greater for Revo-M than for everyday feet. 
The hypothesis will be tested using a 2-sided Wilcoxon matched pairs signed ranks test. If the 
observed p-value is ≤ the Hochberg adjusted critical value and the mean of PLUS-M scores using 
the Revo-M foot is greater than PLUS-M scores using the everyday feet, the null hypothesis will be 
rejected in favor of the alternative hypothesis and the superiority of the Revo-M will be supported. 
Primary Efficacy Endpoint #2: Level of activity restrictions as measured by the Trinity Amputation and 
Prosthesis Experience Scales Activity Restrictions subscale (TAPES-AR). It is hypothesized that 
TAPES-AR scores will be lower for subjects when they are using the Revo-M compared to their 
everyday feet. In statistical terms the null and alternative hypotheses are as follows: 
HO: μRevo-M ≥μEveryday 
HA: μRevo-M < μEveryday 
Where HO  is the null hypothesis, μRevo-M is the mean TAPES-AR score using the Revo-M, μEveryday is 
the mean TAPES-AR score using the everyday feet and HA is the alternative hypothesis indicating 
that level of activity restrictions as measured by the TAPES-AR is less for Revo-M than for everyday 
feet. 
The hypothesis will be tested using a 2-sided Wilcoxon matched pairs signed ranks test. If the 
observed p-value is ≤ the Hochberg adjusted critical value and the mean of TAPES-AR scores using 
the Revo-M foot is less than TAPES-AR scores using the everyday feet, the null hypothesis will be 
rejected in favor of the alternative hypothesis and the superiority of the Revo-M will be supported. 
Secondary Efficacy Endpoints 
Secondary Efficacy Endpoint #1: Level of walking endurance as measured by the distance walked in the 
six-minute walk test (6MWT ) and the perceived exertion (RPE) measured by Borg CR100. No 
hypothesis will be tested. Instead, the percentage of subjects (along with the exact 95% binomial 
confidence interval) with either a clinically meaningful improvement in the distance walked in the six 
minute walk test or a clinically meaningful decrease in the rating of perceived exertion (RPE) while 
wearing the Revo-M foot compared to the everyday foot will be computed. A clinically-significant 
improvement in the 6MWT is defined as a change in distance of greater than 45 meters [Resnik 
2011]. A clinically-significant improvement in the RPE is defined as a change greater than 10 points 
[Ries 2005]. 

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Secondary Efficacy Endpoint #2: Perception of balance confidence as measured by the extended 
Activities-specific Balance Confidence (ABC) Scale. It is hypothesized that ABC scores will be 
higher for subjects when they are using the Revo-M compared to their everyday feet. In statistical 
terms the null and alternative hypotheses are as follows: 
HO: μRevo-M ≤ μEveryday 
HA: μRevo-M > μEveryday 
Where HO  is the null hypothesis, μRevo-M is the mean ABC score using the Revo-M, μEveryday is the 
mean ABC score using the everyday feet and HA is the alternative hypothesis indicating that balance 
confidence as measured by the ABC scale is greater for Revo-M than for everyday feet. 
The hypothesis will be tested using a 2-sided Wilcoxon matched pairs signed ranks test. If the 
observed p-value is ≤ the Hochberg adjusted critical value and the mean of PLUS-M scores using 
the Revo-M foot is greater than PLUS-M scores using the everyday feet, the null hypothesis will be 
rejected in favor of the alternative hypothesis and the superiority of the Revo-M will be supported. 
Secondary Efficacy Endpoint #3: Level of functional satisfaction as measured by the TAPES Functional 
Satisfaction (TAPES-FUN) subscale. It is hypothesized that TAPES-FUN scores will be higher for 
subjects when they are using the Revo-M compared to their everyday feet. In statistical terms the 
null and alternative hypotheses are as follows: 
HO: μRevo-M ≤ μEveryday 
HA: μRevo-M > μEveryday 
Where HO  is the null hypothesis, μRevo-M is the mean TAPES-FUN score using the Revo-M, μEveryday 
is the mean TAPES-FUN score using the everyday feet and HA is the alternative hypothesis 
indicating that level of functional satisfaction as measured by the TAPES-FUN subscale is greater 
for Revo-M than for everyday feet. 
The hypothesis will be tested using a 2-sided Wilcoxon matched pairs signed ranks test. If the 
observed p-value is ≤ the Hochberg adjusted critical value and the mean of TAPES-FUN scores 
using the Revo-M foot is greater than TAPES-FUN scores using the everyday feet, the null 
hypothesis will be rejected in favor of the alternative hypothesis and the superiority of the Revo-M 
will be supported. 
Exploratory Efficacy Endpoints 
Although hypotheses have not been specified, statistical testing will be done using Wilcoxon’s 
matched pairs signed ranks test comparing Revo-M to both comparative devices, the Taleo and the 
ProFlex, and comparing the Revo-M to the everyday foot (baseline at the end of Period I and 
crossover at the end of Period IV). However, as these objectives are exploratory in nature, any 
statistically significant differences will be considered to be hypothesis generating and not definitive. 
These results may be used to guide future studies with prosthetic feet.  

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Time Period 
 
Data collection for all subjects will be collected from the time of enrollment until the end of Period 
IV. Patients may be given the opportunity to continue in Phase V for continued follow-up with the 
Revo-M for an additional 6 months. 
Data Analysis 
Data analysis will be primarily descriptive in nature.  Categorical variables (such as gender) and 
ordinal variables (such as severity of adverse events) will be summarized by absolute and relative 
(percentages) frequencies.   Continuous variables (such as age) will be summarized by the mean, 
median, standard deviation, minimum and maximum values observed.  In addition, change in 
continuous measures of effectiveness (such as PLUS-M scores) will be evaluated by subtracting 
baseline from follow-up scores.   The mean, median, standard deviation, minimum and maximum 
values observed will be used to summarize change scores.  In addition, the significance of 
differences between baseline and follow-up scores may be tested using Wilcoxon’s matched pairs 
signed ranks test.  Two-tailed p-values ≤ 0.05 will indicate statistical significance.  Each variable will 
be analyzed separately.  For each variable analyzed, only subjects with valid values will be included in 
the analysis.  A subject need not have valid values on all variables to be included in the analysis of 
any given variable. 
Risk-Benefit Analysis 
The potential risks and benefits of the Revo-M as well as the comparative devices, Taleo and 
ProFlex XC, are identified in the Instructions for Use.  
Risks and Minimization of Risks 
The Revo-M devices to be assessed in this study will have undergone thorough verification testing. 
The risk analysis for the Revo-M prosthetic foot resulted in a list of known or expected risks as 
shown in the table below. All were deemed “As Low As Reasonably Possible.” 
Risk 
Potential harm 
Injury 
Function lost 
Health hazard 
Damage/ Break of load bearing parts 
X 
 
 
Break of functionally relevant parts 
X 
 
 
Failure of the guide elements for the tension element 
X 
X 
 
The connection to the prosthesis is lost 
X 
 
 
Foot twists 
X 
 
 
Damage to the product during manufacture or use 
X 
 
 
Incorrect alignment 
X 
 
 
Not compliance with the assembly guidelines 
X 
 
 
Mechanical damage 
X 
 
 
Mechanical damage of load bearing parts 
X 
X 
 

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Risk 
Potential harm 
Injury 
Function lost 
Health hazard 
Use not according to the MOBIS classification 
X 
 
 
Use without foot cover 
X 
 
 
Overload of the prosthesis caused by unsuitable combination of 
prosthetic components 
X 
 
 
Weight limit is not specified or not readable 
X 
 
 
Safety instructions are not sufficiently described 
 
 
X 
Use on more than one user 
X 
X 
 
Product is used too long 
X 
 
 
Exceeding the time-stability of supporting structures 
X 
 
 
 
The following risk-minimizing measures will be taken: 
x The subjects will be individually fit by an experienced CPO and instructed to report to the 
CPO all the problems with the prosthesis. The CPO will be trained by Ottobock in the 
handling of the new prosthetic foot. 
x The first steps with the new prosthesis will be deliberately accompanied by exercises which 
accelerate adaptive behavior and train proper behavior in critical situations. 
x The subjects will be instructed that in case of any technical issues concerning the prosthesis, 
they should stop using it until the issue is resolved and to contact the investigational site to 
schedule further steps. 
x The participants will be informed that they should refrain from performing any activity if 
they do not feel confident or safe. 
x All activities during in-clinic tests will be performed under the close supervision of qualified 
personnel. 
x The Revo-M investigational device used in the study has passed a fatigue test for 750,000 
gait cycles corresponding to approximately 9 months of use. 
The risks to subjects inherent in study procedures are limited to those associated with the six-minute 
walk test. Complications associated with this test include excessive fatigue, angina, or light-
headedness. Subjects’ blood pressure and resting heart rate will be measured prior to the test in 
accordance with recommendations from the American Thoracic Society (ATS Statement, 2002). 
Subjects will be encouraged to stop during the test if needed to catch their breath, and the test may 
be stopped by the investigator if subjects exhibit symptoms listed above. 
Benefits 
Subjects may or may not experience benefits such as improved walking performance during the 
course of the study while wearing the study devices. In any case, all subjects will need to return the 
study devices at the end of the study and return to using their existing ESR feet. However, the study 

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results may help the Sponsor identify ways to improve future versions of the Revo-M. In addition, 
by characterizing the comparative safety and effectiveness of the Revo-M (relative to both existing 
ESR feet and the two comparative study feet), society, the O&P industry, and the Investigators may 
also benefit from the knowledge gained. 
Study Management 
Sponsor Responsibilities 
Sponsor responsibilities include: 
1. Ensuring the study is designed and managed in compliance with all appropriate regulatory 
standards and is conducted according to the Study Protocol. 
2. Selecting Investigators qualified by training and experience to participate in the study. 
3. Providing adequate training to Investigators, site research staff, and all Sponsor 
representatives. 
4. Monitoring study data at investigational sites, including that proper informed consent is 
obtained prior to data collection and that patient confidentiality remains acceptable for the 
duration of the study. 
5. Ensuring that prior to commencement of the study in each participating center, Sponsor has 
on file:  
a. Written IRB approval 
b. Signed Investigator’s Agreement 
c. Investigator’s current curriculum vitae 
Investigator Responsibilities 
The Investigators will strictly follow requirements as stated in the Declaration of Helsinki and 
applicable local laws and regulations governing the conduct of clinical studies and subject data 
protection. They will be responsible for conducting the study as described in the Study Protocol and 
for the clinical well-being of the patients involved. 
Records and Reports 
The Investigator must retain all records and reports pertaining to this study. Electronic CRFs will be 
completed via Electronic Data Capture system by the Investigator. Completed originals of the 
source documents will be kept by the Investigator, if applicable. In addition, the following 
documents will be retained by the Investigator in each study site:   
1. IRB correspondence, including approval letter, approved consent forms and annual or final 
reports if applicable 
2. Sponsor correspondence 
3. Source documents, signed data collection forms, medical records, office charts 

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4. Qualifications and evidence of training 
5. Signed informed consent forms  
6. Original Study Protocol and all revisions  
7. Signed Study Agreement 
8. Records concerning adverse events 
All study documents will be retained by the Sponsor and Investigators for at least 2 years following 
the end of the study or earlier if approved by the Sponsor. No study documents will be destroyed or 
moved to a new location without prior written approval from the Sponsor. If the Investigator 
relocates, retires, or withdraws from the study for any reason, all records required to be maintained 
for the study should be transferred to an agreed-upon designee, such as another Investigator, or the 
institution where the study was conducted. 
Investigator Reports 
Table 5: Investigator Reports 
Report 
Submit To 
Description 
Unanticipated 
Adverse Device 
Effects 
IRB, Sponsor 
Notification within five working days after the investigator 
first learns of the event. 
Withdrawal of IRB 
Approval 
Sponsor 
Notification within five working days 
Sponsor Records 
Sponsor will maintain the following records at a minimum: 
x All significant correspondence which pertains to the investigation 
x Signed Investigator agreements and curriculum vitae 
x System/fitting related Adverse Device Effects and complaints 
x All case report forms, including samples of patient informed consents, submitted by the 
Investigator and the Study Protocol 
x Clinic staff training and study visit reports 
x Sponsor will own and store the clinical data gathered in this study 

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Sponsor Reports 
Table 6: Sponsor Reports 
Report 
Submit To 
Description 
Unanticipated 
Adverse Device 
Effects (US) 
Investigators, IRB 
Notification within five working days after the sponsor 
first learns of the event. 
Withdrawal of IRB 
Approval 
Investigators, IRB 
Notification within five working days 
Annual Report 
Investigators 
Report detailing the annual progress of the study.  
Final Report 
Investigators, IRB 
Sponsor will notify the Investigator(s) within 30 working 
days of the completion or termination of the study. The 
Investigators will in turn inform their IRB. A final report 
will be submitted to the Investigator(s) after completion 
or termination of this study. The Investigator should 
confirm the receipt of the final report composed by 
Sponsor. The Investigator will also forward a copy of the 
report to their IRB. 
Monitoring procedures 
The study site is required to conduct the study in accordance with the Study Protocol, all applicable 
laws and Federal regulations and any conditions or restrictions imposed by the reviewing IRB. The 
Sponsor will incorporate monitoring of the study with attention to verification of clinical 
requirements, adherence to Study Protocol, and compliance with applicable government and 
institutional regulations. If necessary, the Investigator will provide the monitor access to all 
necessary records to ensure the integrity of the data. 
The Investigator(s) and institution(s) will permit monitoring, audits, IRB review, and regulatory 
inspections and provide direct access to source documents.  Study sites may be monitored on a 
periodic basis throughout the course of the study. 
Study monitors 
Sponsor designated Clinical Research Specialists or appropriately trained staff will complete any 
monitoring for this study. 
Site Visits 
Site initiation visits may be made by the Monitor to review the Study Protocol and documentation 
requirements with the Investigator and clinic support staff involved with the study. The Sponsor will 
ensure that all researchers involved in the project have adequate training. 
Ongoing monitoring visits of the study centers may be conducted to compare the data recorded in 
the eCRFs with the information contained in the original source documents (source data 
verification). Monitoring, when conducted, will include at a minimum the following items: 
x Patient identification number 
x Patient signed informed consent obtained  

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x Medical record of Adverse Events 
Management of the study sites will be predominantly achieved by communications via letter, fax, 
electronic mail and/or telephone. 
Site closure activities will be conducted after all patients have been enrolled and data collection has 
been completed if deemed necessary. Site closure may be conducted by site visits or by telephone as 
determined by the Sponsor. 
Monitoring Reports 
Reports of any monitoring visits will be prepared and maintained by the Sponsor which include: 
x The date of the visit 
x The name of the individual who conducted the visit 
x The name and address of the Investigator visited 
x Statement of the findings, conclusions and actions taken to correct any deficiencies noted 
during the visit 
Study Discontinuation or Termination 
Investigational Site Termination 
The Sponsor reserves the right to terminate a research site for any of the following reasons: 
1. Failure to secure Informed Consent from a patient enrolled into the study  
2. Repeated Study Protocol violations 
3. Repeated failure to complete Electronic Case Record Forms on a timely basis 
4. Failure to report Adverse Events on a timely basis 
5. The Investigator requests discontinuation 
Premature Discontinuation of the study 
If the study is prematurely terminated or suspended, the Sponsor or designate will promptly inform 
the Investigators/institutions of the termination or suspension and the reason(s) for the termination 
or suspension. The IRB will be informed promptly, if applicable, and provided with a detailed 
written explanation for the termination or suspension by the Sponsor or by the 
Investigator/institution, as specified by the applicable regulatory requirement(s). 
Ethical Statement 
Institutional Review Board (IRB) 
Prior to initiation of the study, the Study Protocol, patient informed consent, and any other relevant 
study documentation will be submitted to a central IRB. For each participating center, IRB approval 
must be obtained, either through the central or local IRB, and forwarded to the Sponsor before data 
collection at the site can be initiated. Furthermore, any necessary extension or renewal of the IRB 
approval must be obtained and forwarded to the Sponsor. In particular, change(s) to any aspect of 

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the study, such as modification(s) of the Study Protocol, the written informed consent form, or any 
written information provided to patients must be approved, in writing, by the IRB. 
The Investigator at the study site will report promptly to the IRB any new information that may 
adversely affect the conduct of the study. Similarly, the Investigator will submit written summaries 
of the study status to the IRB annually, or more frequently, if requested by the IRB. Upon 
completion of the study, the Investigator will provide the IRB with a brief report of the outcome of 
the study, if required. 
Ethical conduct of the study 
The study is to be conducted according to the approved Study Protocol. The Guidelines of the 
World Medical Association Declaration of Helsinki and the HIPAA Privacy Rule will be strictly 
followed as well as any other applicable rules and regulations. 
Disclosure of data and publication policy 
Disclosure of data 
By signing the final Study Protocol, every participating Investigator agrees to keep all information 
and results concerning the study confidential for as long as the data remain unpublished. The 
confidentiality obligation applies to all personnel involved at the investigational site. Publication of 
study results requires mutual agreement between the Investigator(s) and the Sponsor. 
Sponsor may disclose data derived from the study to other Investigators and domestic or foreign 
regulatory authorities.  
Publication policy 
Any proposed publications that are to make public any findings, data, or results of the study shall be 
submitted to the Sponsor for review and comment at least sixty (60) days prior to submission of 
manuscript for an abstract. In addition, the Researchers shall delay any proposed 
publication/presentation an additional sixty (60) days in the event Sponsor so requests in order to 
enable Sponsor to secure patent or other proprietary protection for any invention(s) disclosed in 
such publication/presentation. Sponsor reserves the exclusive right to publish the complete 
multicenter, accumulated results of the study and to decide, based on study conduct, compliance, 
and willingness of the Investigators to accept the responsibilities of authorship, which Investigators 
will be authors and the order of authorship e.g., first author, second author, and third author, etc., 
for the study group. In all publications, credit shall be given to Sponsor for its sponsorship of the 
study. 
 
 

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Contact information 
US Sponsor Representative: 
Otto Bock Healthcare LP 
11501 Alterra Parkway, Suite 600 
Austin, TX 78758, USA 
www.ottobockus.com 
Russ Lundstrom, Director of Clinical and Field Clinical Services 
russ.lundstrom@ottobock.com 
Tel +1 800-328-4058 
Contracts, finances 
In addition to the Study Protocol, study-related duties, functions and financial aspects will be 
specified in a separate contract between the Sponsor and the Investigator as well as any other parties 
involved with the study. 
 
 

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