Case Report Form

A research on the efficacy and safety of Bongener/Bongros on extremity fractures

Version /Date 1.0/2016/12/22

Institution RSUD Dr. Moewardi, Solo, Indonesia

Principal Investigator Dr. Bintang

Subject Initial

Subject Identified Number

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Subject information (Screening)
Visit date / / (YY/MM/DD)
Sex ☐Male ☐Female Age 26
Height ( ) cm Body weight () kg

☐Yes☐No ☞ If “yes”, please describe in detail below

Disease history
Comment
☐Yes☐No ☞ If “yes”, please describe in detail below
Surgical history
Comment
☐proximal humerus☐distal radius ☐distal tibia☐distal femur fracture☐etc (CF Avulsi Condylus Medialis Femur (S), CF roof
Fracture region
Acetabulum (S)
Fracture size ( ) cm

Inclusion/ Exclusion Criteria

Inclusion Yes No

1. Patients ranging in age from 20 to 60 ☐ ☐

2.Patients with extremity fractures (proximal humerus fracture, distal radius fracture, distal tibia fracture, distal femur fracture) ☐ ☐
Exclusion Yes No

1. Patients who had a previous bone fracture in the 2 years prior to enrollment ☐ ☐
2. Patients with pre-existing wrist disability or arthrosis ☐ ☐
3. Patients who cannot understand the study (illiterate, foreigner, mentally retarded patient, etc.) ☐ ☐
4. Patients who cannot participate in the study based on investigator’s opinion ☐ ☐

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 Screening (Visit 1) : Date 2016/8/28 (YYYY/MM/DD)
Photo Functional outcome
☐x-ray ☐CT ☐MRI ☐ constant☐DASH☐FAOS☐SF-36
Total score = ( )

Safety Evaluation
Vital sign
Pressure SBP ( ) DBP ( )
Heart rate ( )
Note

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page4 / 23
page5 / 23
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 Operation (Visit 2) : Date 2017-01-21 (YYYY/MM/DD)
Photo Investigational Product
☐x-ray ☐CT ☐MRI ☐Bongener( )cc
☐Bongros( )cc
☐ combination of Bongener + Bongros
(Bongener( )cc , Bongros( )cc
Safety Evaluation
Vital sign
Pressure SBP ( ) DBP ( )
Heart rate ( )

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 Adverse event ☐Y☐ N
☞ If “yes”, describe in detail ( )
Note

2W (Visit 3) : Date / / (YYYY/MM/DD)

Photo Safety Evaluation
☐x-ray ☐CT ☐MRI Vital sign
Pressure SBP ( ) DBP ( )
Heart rate ( )

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 Adverse event ☐Y☐ N
☞ If “yes”, describe in detail ( )
Note

6W (Visit 4) : Date / / (YYYY/MM/DD)

Photo Safety Evaluation
☐x-ray ☐CT ☐MRI Vital sign
Pressure SBP ( ) DBP ( )
Heart rate ( )
Adverse event ☐Y☐ N
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 ☞ If “yes”, describe in detail ( )
Note

3M (Visit 5) : Date / / (YYYY/MM/DD)

Photo Bone Fusion Evaluation
☐x-ray ☐CT ☐MRI ☐ Fusion ☐ Non-fusion
* Definition of fusion by x-ray :
1) trabeculae across the nonunion site
2) no gap visible

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 Functional outcome
☐ constant ☐DASH ☐FAOS ☐SF-36
Total score = ( )

Safety Evaluation
Vital sign
Pressure SBP ( ) DBP ( )
Heart rate ( )
Adverse event ☐Y☐ N
☞ If “yes”, describe in detail ( )
Note

6M (Visit 6) : Date / / (YYYY/MM/DD)

Photo Bone Fusion Evaluation
☐x-ray ☐CT ☐MRI ☐ Fusion ☐ Non-fusion
* Definition of fusion by x-ray :
1) trabeculae across the nonunion site

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 2) no gap visible

Functional outcome
☐ constant ☐DASH ☐FAOS ☐SF-36
Total score = ( )

Safety Evaluation
Vital sign
Pressure SBP ( ) DBP ( )
Heart rate ( )
Adverse event ☐Y☐ N
☞ If “yes”, describe in detail ( )
Note

12M (Visit 7) : Date / / (YYYY/MM/DD)

Photo Bone Fusion Evaluation
☐x-ray ☐CT ☐MRI ☐ Fusion ☐ Non-fusion
* Definition of fusion by x-ray :

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 1) trabeculae across the nonunion site
2) no gap visible

Functional outcome
☐ constant ☐DASH ☐FAOS ☐SF-36
Total score = ( )

Safety Evaluation
Vital sign
Pressure SBP ( ) DBP ( )
Heart rate ( )
Adverse event ☐Y☐ N
☞ If “yes”, describe in detail ( )
Note

18 M (additional visit) : Date / / (YYYY/MM/DD)

Photo Bone Fusion Evaluation
☐x-ray ☐CT ☐MRI ☐ Fusion ☐ Non-fusion

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 * Definition of fusion by x-ray :
1) trabeculae across the nonunion site
2) no gap visible

Functional outcome
☐ constant ☐DASH ☐FAOS ☐SF-36
Total score = ( )

Safety Evaluation
Vital sign
Pressure SBP ( ) DBP ( )
Heart rate ( )
Adverse event ☐Y☐ N
☞ If “yes”, describe in detail ( )
Note

Appendix 1
Clinician’s Name: ____________________________
Patient’s Name: ___________________________
Constant Shoulder Score
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 During the past 4 weeks.
Answer all questions, selecting just one unless otherwise stated
Parameters Points ☐ 151~180 10
1. Pain 15 (2) Forward elevation 10
☐ None 15 ☐ 0~30 0
☐ Mild 10 ☐ 31~60 2
☐ Moderate 5 ☐ 61~90 4
☐ Severe 0 ☐ 91~120 6
Total for pain ( ) ☐ 121~150 8
2. Activities of daily living 20 ☐ 151~180 10
(1) Activity level (3) External Rotation 10
☐ Full work 4 ☐ Hand behind head with elbow held forward 2
☐ Full recreation/sport 4 ☐ Hand behind head with elbow held back 2
☐ Unaffected sleep 2 ☐ Hand on top of head with elbow held forward 2
(2) Positioning ☐ Hand on top of head with elbow held back 2
☐ Up to waist 2 ☐ Full elevation from on top of head 2
☐ Up to xiphoid 4 (4) Internal Rotation of the shoulder 10
☐ Up to neck 6 ☐ Dorsum of hand to lateral thigh 0
☐ Up to top of head 8 ☐ Dorsum of hand to buttock 2
☐ Above head 10 ☐ Dorsum of hand to lumbosacral junction 4
Total for activities of daily living ( ) ☐ Dorsum of hand to waist (3rd lumbar vertebra) 6
3. Range of motion 40 ☐ Dorsum of hand to 12th dorsal vertebra 8
(1) Abduction 10 ☐ Dorsum of hand to interscapular region (DV 7) 10
☐ 0~30 0 Total for range of motion ( )
☐ 31~60 2 4. Strength (1 to 25) 25
☐ 61~90 4 Measured at 90 lateral abduction (1 point per 0.5 kg, max. 25 points)
☐ 91~120 6 Total of power ( )
☐ 121~150 8 The Constant Shoulder Score = ( )/100

DASH Score
Appendix 2

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Clinician’s Name: ____________________________

Patient’s Name: ___________________________

Please rate your ability to do the following activities in the last week.
Questionnaire Point
1 2 3 4 5
1. Open a tight or new jar ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ Unable
2. Write ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ Unable
3. Turn a key ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ Unable
4. Prepare a meal ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ Unable
5. Push open a heavy door ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ Unable
6. Place an object on a shelf above your head ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ Unable
7. Do heavy household chores (eg wash walls, wash floors) ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ Unable
8. Garden or do yard work ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ Unable
9. Make a bed ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ Unable
10. Carry a shopping bag or briefcase ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ Unable
11. Carry a heavy object (over 10 ibs) ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ Unable
12. Change a lightbuld overhead ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ Unable
13. Wash or blow dry your hair ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ Unable
14. Wash your back ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ Unable
15. Put on a pullover sweater ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ Unable
16. Use a knife to cut food ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ Unable
17. Recreational activities which require little effort(egcardplaying, ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ Unable
knitting, etc)
18. Recreational activities in which you take some force or impact ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ Unable
through your arm, shoulder or hand (eg golf, hammering, tennis,
etc)
19. Recreational activities in which you move your arm freely (eg ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ Unable
playing frisbee, badminton, etc)
20. Manage transportation needs (getting from one place to ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ Unable
another)
21. Sexual activities ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ Unable
22. During the past week, to what extent has your arm, shoulder ☐ Not at all ☐ Slightly ☐ Moderately ☐ Quite a bit ☐ Extremely

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or hand problem interfered with your normal social activities with
family, friends, neighbours or groups?
23. During the past week, were you limited in your work or other ☐ Not limited ☐ Slightly ☐ Moderately limited ☐ Very limited ☐ Unable
regular daily activities as a result of your arm, shoulder or hand at all limited
problem?
Please rate the severity of the following symptoms in the last week
24. Arm, shoulder or hand pain ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
25. Arm, shoulder or hand pain when you performed any specific ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
activity
26. Tingling (pins and needles) in your arm, shoulder or hand ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
27. Weakness in your arm, shoulder or hand ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
28. Stiffness in your arm, shoulder or hand ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
29. During the past week, how much difficulty have you had ☐ No difficulty ☐ Mild difficulty ☐ Moderate difficulty ☐ Severe difficulty ☐ So much I
sleeping because of the pain in your arm, shoulder or hand? can’t sleep
30. I feel less capable, less confident or less useful because of my ☐ Strongly ☐ Disagree ☐ Neither agree nor ☐ Agree ☐ Strongly
arm, shoulder or hand problem disagree disagree agree

*DASH score = (mean of total completed score -1) x 25

The interpretation of scores is shown below;
*Interpretation of scores

Score Interpretation

< 15 No problem

16- 40 Problem, but working

> 40 Unable to work

Appendix 3 FAOS score

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Clinician’s Name: ____________________________ foot/ankle andhow well you are able to do your usual activities.
Patient’s Name: ___________________________
Answer every question by ticking the appropriate box, only one box for
eachquestion. If you are unsure about how to answer a question, please
INSTRUCTIONS: This survey asks for your view about your foot/ankle.
give thebest answer you can.
Thisinformation will help us keep track of how you feel about your
Symptoms
These questions should be answered thinking of your foot/ankle symptomsduring the last week.
point
1 2 3 4 5
S1. Do you have swelling in your foot/ankle? ☐ Never ☐ Rarely ☐ Sometimes ☐ Often ☐ Always
S2. Do you feel grinding, hear clicking or any other type of noise when your ☐ Never ☐ Rarely ☐ Sometimes ☐ Often ☐ Always
foot/ankleoves?
S3. Does your foot/ankle catch or hang up when moving? ☐ Never ☐ Rarely ☐ Sometimes ☐ Often ☐ Always
S4. Can you straighten your foot/ankle fully? ☐ Always ☐ Often ☐ Sometimes ☐ Rarely ☐ Never
S5. Can you bend your foot/ankle fully? ☐ Always ☐ Often ☐ Sometimes ☐ Rarely ☐ Never

Stiffness
The following questions concern the amount of joint stiffness you haveexperienced during the last week in your foot/ankle. Stiffness is a sensation of
restriction or slowness in the ease with which you move your joints.
point
1 2 3 4 5
S6. How severe is your foot/ankle stiffness after first wakening in the morning? ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
S7. How severe is your foot/ankle stiffness after sitting, lying or resting later in the ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
day?

Pain
point
1 2 3 4 5

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P1. How often do you experience foot/ankle pain? ☐ Never ☐ Monthly ☐ Weekly ☐ Daily ☐ Always
What amount of foot/ankle pain have you experienced the last week during thefollowing activities?
P2. Twisting/pivoting on your foot/ankle ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
P3. Straightening foot/ankle fully ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
P4. Bending foot/ankle fully ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
P5. Walking on flat surface ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
P6. Going up or down stairs ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
P7. At night while in bed ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
P8. Sitting or lying ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
P9. Standing upright ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme

Function, daily living

The following questions concern your physical function. By this we mean yourability to move around and to look after yourself. For each of the following
activities please indicate the degree of difficulty you have experienced in thelast week due to your foot/ankle.
point
1 2 3 4 5
A1. Descending stairs ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
A2. Ascending stairs ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
For each of the following activities please indicate the degree of difficulty youhave experienced in the last week due to your foot/ankle.
1 2 3 4 5
A3. Rising from sitting ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
A4. Standing ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
A5. Bending to floor/pick up an object ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
A6. Walking on flat surface ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
A7. Getting in/out of car ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
A8. Going shopping ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
A9. Putting on socks/stockings ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
A10. Rising from bed ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
A11. Taking off socks/stockings ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme

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A12. Lying in bed (turning over, maintaining foot/ankle position) ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
A13. Getting in/out of bath ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
A14. Sitting ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
A15. Getting on/off toilet ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
For each of the following activities please indicate the degree of difficulty youhave experienced in the last week due to your foot/ankle.
1 2 3 4 5
A16. Heavy domestic duties (moving heavy boxes, scrubbing floors, etc) ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
A17. Light domestic duties (cooking, dusting, etc) ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme

Function, sports and recreational activities

The following questions concern your physical function when being active on ahigher level. The questions should be answered thinking of what degree of
difficulty you have experienced during the last week due to your foot/ankle.
point
1 2 3 4 5
SP1. Squatting ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
SP2. Running ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
SP3. Jumping ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
SP4. Twisting/pivoting on your injured foot/ankle ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
SP5. Kneeling ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
Quality of Life
point
1 2 3 4 5
Q1. How often are you aware of your foot/ankle problem? ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
Q2. Have you modified your life style to avoid potentially damaging activities ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
to your foot/ankle?
Q3. How much are you troubled with lack of confidence in your foot/ankle? ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme
Q4. In general, how much difficulty do you have with your foot/ankle? ☐ None ☐ Mild ☐ Moderate ☐ Severe ☐ Extreme

Appendix 4

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SF-36 Score section. Scores range from 0 - 100
Lower scores = more disability, higher scores = less disability
Clinician’s Name: ____________________________ Vitality
Patient’s Name: ___________________________
Medical Outcomes Study Questionnaire Short Form 36 Health Survey
Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) This survey asks for your views about your health. This information will help keep track of
About: The SF-36 is an indicator of overall health status. how you feel and how well you are able to do your usual activities. Thank you for
Items: 10 completing this survey! For each of the following questions, please circle the number that
Scoring: best describes your answer.
The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each

Yes, Yes, No, Not

1. In general, would you say your health is: point Limited a Limited a limited at
☐ Excellent 1 Lot (1 point) Little (2 All (3
☐ Very good 2 points) points)
☐ Good 3 3. Vigorous activities, such as running, ☐ ☐ ☐
☐ Fair 4 lifting heavy objects, participating in
☐ Poor 5 strenuous sports

2. Compared to one year ago, 4. Moderate activities, such as moving a ☐ ☐ ☐

☐ Much better now than one year ago 1 table, pushing a vacuum cleaner,bowling,

☐ Somewhat better now than one year ago 2 or playing golf

☐ About the same 3 5. Lifting or carrying groceries ☐ ☐ ☐

☐ Somewhat worse now than one year ago 4 6. Climbing several flights of stairs ☐ ☐ ☐

☐ Much worse now than one year ago 5 7. Climbing one flight of stairs ☐ ☐ ☐
8. Bending, kneeling, or stooping ☐ ☐ ☐
9. Walking more than a mile ☐ ☐ ☐
10. Walking several blocks ☐ ☐ ☐
11. Walking one block ☐ ☐ ☐
12. Bathing or dressing yourself ☐ ☐ ☐

During the past 4 weeks, have you had any of the following problems with your work
The following items are about activities you might do during a typical day. Does your or other regular daily activities as a result of your physical health?
health now limit you in these activities? If so, how much? Yes No

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 (1 point) (2 points) 22. During the past 4 weeks, how much did pain interfere with your normal point
13. Cut down the amount of time you spent on work or other ☐ ☐ work (including both work outside the home and housework)?
activities ☐ Not at all 1
14. Accomplished less than you would like ☐ ☐ ☐ A little bit 2
15. Were limited in the kind of work or other activities ☐ ☐ ☐ Moderately 3
16.. Had difficulty performing the work or other activities (for ☐ ☐ ☐ Quite a bit 4
example, it took extra effort)
These questions are about how you feel and how things have been with you during the
During the past 4 weeks, have you had any of the following problems with your work past 4 weeks. For each question, please give the one answer that comes closest to the
or other regular daily activities as a result of any emotional problems (such as feeling way you have been feeling.
depressed or anxious)? 9. How much of the time during the past 4 weeks .
Yes No All of Most of A Some of A Little of None of
(1point) (2points) the the Time GoodBit the Time the Time the Time
Time (2 of (4 (5 points) (6
17. Cut down the amount of time you spent on work or other ☐ ☐
(1 points) theTime points) points)
activities
point) (3
18. Accomplished less than you would like ☐ ☐
points)
19. Didn't do work or other activities as carefully as usual ☐ ☐
23. Did you feel full ☐ ☐ ☐ ☐ ☐ ☐
of pep?
20. During the past 4 weeks, to what extent has your physical health or point 24. Have you been a ☐ ☐ ☐ ☐ ☐ ☐
emotional problems interfered with your normal social activities with family, very nervous person?
friends, neighbors, or groups?
25. Have you felt so ☐ ☐ ☐ ☐ ☐ ☐
☐ Not at all 1 down in the dumps
☐ Slightly 2 that nothing could
☐ Moderately 3 cheer you up?
☐ Quite a bit 4 26. Have you felt ☐ ☐ ☐ ☐ ☐ ☐
☐ Extremely 5 calm and peaceful?
21. How much bodily pain have you had during the past 4 weeks? point 27. Did you have a ☐ ☐ ☐ ☐ ☐ ☐
☐ None 1 lot of energy?
☐ Very mild 2 28. Have you felt ☐ ☐ ☐ ☐ ☐ ☐
☐ Mild 3 downhearted and
☐ Moderate 4 blue?
☐ Severe 5 29. Did you feel worn ☐ ☐ ☐ ☐ ☐ ☐
☐ Very severe 6 out?

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30. Have you been a ☐ ☐ ☐ ☐ ☐ ☐ How TRUE or FALSE is each of the following statements for you.
happy person? Definitely Mostly Don't Mostly Definitely

31. Did you feel ☐ ☐ ☐ ☐ ☐ ☐ True (1 True (2 Know (3 False (4 False (5

point) points) points) points) points)
tired?
33. I seem to get sick a ☐ ☐ ☐ ☐ ☐
little easier than other
32. During the past 4 weeks, how much of the time has your physical point
people
health or emotional problems interfered with your social activities (like
34. I am as healthy as ☐ ☐ ☐ ☐ ☐
visiting with friends, relatives, etc.)?
anybody I know
☐ All of the time 1
35. I expect my health to ☐ ☐ ☐ ☐ ☐
☐ Most of the time 2
get worse
☐ Some of the time 3
36. My health is excellent ☐ ☐ ☐ ☐ ☐
☐ A little of the time 4
☐ None of the time 5

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