Clinical Study to Assess the Effectiveness of the Device Patello
Phase: NA
Conditions: Passiv Continuous Patella Mobilisation
Sponsor: University of Applied Sciences and Arts of Southern Switzerland

 
 
  
  
  
Clinical trial study to investigate the effectiveness of the Patellos 
device  
  
Clinical Study Protocol  
  
  
Lemma:  
Effectiveness study Patello  
  
Study Type:  
Clinical trial with a medical device of risk group C  
Study Categorisation:  
Clinical trial with a category C medical device in accordance 
with the Swiss Ordinance on Clinical Trials in Human Research 
(ClinO: Art. 20)  
Study Registration:  
-  
Study Identifier:  
-   
Sponsor:   
  
  
  
  
  
  
Investigator:  
Thim van der Laan AG 
Thim van der Laan jr.  
 Weststrasse 8, 7302 Landquart  
 +41 81 300 01 70  
  
Contact / Director of Studies  
Dr. Clijsen Ron, PhD  
University of Applied Sciences and Arts Southern Switzerland, 
SUPSI  
Physiotherapy Graubünden   
Weststrasse 8, 7302 Landquart  
Phone: +41 81 300 01 75 
ron.clijsen@supsi.ch  
Investigational Product:  
Patello (Patella Mobility, Srm-Projects GmbH, Chur)  
Protocol Version and Date:  
Study protocol – Version 01 – 05.04.2018  
  
  
  
  
  
  
  

 
 
CONFIDENTIALITY   
 
 
Effectiveness study Patello  
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The information in this protocol is confidential and the property of the University of Applied Sciences 
and Arts Southern Switzerland (SUPSI), Department of Business Economics, Health and Social 
Care, Physiotherapy Graubünden in Landquart, Switzerland. The content of this protocol should not be 
forwarded, reproduced, published or passed on to others – neither in full text version nor in parts thereof 
– without the written consent of the head of the institute. Exceptions to this are the statements in the 
subject information and the declaration of consent of the study participants.  

  
  
  
  
  
  
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 TABLE OF CONTENTS  
 
STUDY SCHEDULE ............................................................................................................................ 16 
1 STUDY ADMINISTRATION .............................................................................................................. 17  
1.1  
Sponsor...................................................................................................................................... 17  
1.2  
Investigator................................................................................................................................. 17  
1.3  
Examiner.................................................................................................................................... 17  
1.4  
Statistician.................................................................................................................................. 18  
1.5  
Head of the Research Laboratory (Investigator) ....................................................................... 18  
1.6  
Monitoring of the study (monitoring) .......................................................................................... 18  
1.7  
Privacy........................................................................................................................................ 18  
1.8  
Other participating committees or institutes .............................................................................. 19  
2  
ETHICAL AND REGULATORY ASPECTS................................................................................ 20  
2.1  
Study Registration ..................................................................................................................... 20  
2.2  
Categorization of the study ........................................................................................................ 20  
2.3  
Competent Ethics Committee (CEC) ......................................................................................... 20  
2.4  
Competent Authorities (CA) ....................................................................................................... 20  
2.5  
Ethical Leadership of the Study ................................................................................................. 20  
2.6  
Conflict........................................................................................................................................ 20  
2.7  
Patient information and informed consent ................................................................................. 21  
2.8  
Confidentiality & Privacy............................................................................................................. 21  
2.9  
Early termination of the study .................................................................................................... 21  
2.10  Adjustments to the protocol ....................................................................................................... 21  
3  BACKGROUND AND RATIONALE ................................................................................................. 23  
3.1  
Background and reasoning...................................................................................................... 23  
3.2  
Medical product and indication ............................................................................................... 28  
3.3  
Preclinical evidence ................................................................................................................ 29  
3.4  
Current clinical evidence ......................................................................................................... 29  
3.5  
Medical product: Type of application in the study ................................................................... 30  
3.6  
Intervention Patello.................................................................................................................. 30  
3.7  
Risk/Benefits ........................................................................................................................... 30  

  
  
  
  
  
  
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4  STUDY OBJECTIVES .................................................................................................................... 32  
4.1  
General objectives .................................................................................................................. 32 
4.2  
Primary objectives ................................................................................................................... 32 
4.3  
Secondary Objectives ............................................................................................................. 32 
4.4  
Other safety aspects (long-term) ............................................................................................ 32 
5  STUDY OUTCOMES ...................................................................................................................... 33 
5.1  
Primary outcomes .................................................................................................................. 33 
5.2  
Secondary outcomes .............................................................................................................. 33  
6  STUDY DESIGN ............................................................................................................................ 34  
6.1  
Method for minimizing influencing factors ............................................................................... 34  
6.1.1 Randomization ..................................................................................................................... 34  
6.1.2 Blinding ................................................................................................................................ 34  
6.1.3 Other Methods ..................................................................................................................... 34  
6.2  
.Procedure for unblinding (code break) ................................................................................... 34  
6.3  
Procedure for unblinding (code break) .................................................................................... 35  
7  STUDIES POPULATION .................................................................................................................. 36  
7.1  
Inclusion criteria ...................................................................................................................... 36  
7.2  
Recruitment and screening ..................................................................................................... 36  
7.3  
Group assignment ................................................................................................................... 37  
7.4  
Discontinuation of study participation ..................................................................................... 37 
8 STUDY INTERVENTION .................................................................................................................. 38  
8.1  
Medical Device ID ................................................................................................................... 38  
8.1.1 Intervention product ............................................................................................................. 38  
8.1.2 Control intervention .............................................................................................................. 39  
8.1.3 Packaging, labeling and use ................................................................................................ 39  
8.1.4 Storage ................................................................................................................................. 40  
8.2  
Administration of the experiment .............................................................................................. 40  
8.2.1 Experimental Intervention ..................................................................................................... 40  
8.2.2 Control intervention .............................................................................................................. 40  
8.3  
Dosage, Application Modification ........................................................................................ 40  
8.4  
Adherence to the study intervention ........................................................................................... 40  
8.5  
Follow-up treatment of eliminated participants ....................................................................... 40  

  
  
  
  
  
  
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8.6  
Preventive measurements ...................................................................................................... 40  
8.7  
Accompaniments..................................................................................................................... 41  
8.8  
Liability..................................................................................................................................... 41  
8.9  
Return of the medical device .................................................................................................. 41  
9  STUDY STRUCTURE & EVALUATION............................................................................................ 42  
9.1  
Schedule Study Protocol ......................................................................................................... 42  
9.1.1 Measurement of primary and secondary outcomes ............................................................. 42  
9.1.2 Measuring primary outcomes ............................................................................................... 42  
9.1.3 Measuring Secondary Outcomes ......................................................................................... 42  
9.1.4 Collection of further results ................................................................................................... 42 
9.1.5 Collection of safety parameters ............................................................................................ 43 
9.1.6 Collection of data in case of early termination of studies ...................................................... 43 
9.2  
Procedure at each visit of the test subjects ........................................................................... 43 
9.2.1 Subject recruitment – screening and randomization ............................................................ 43 
9.2.2 Preparation of subjects ........................................................................................................ 43 
9.2.3 Sequence of measurements ................................................................................................ 44  
9.2.4 Multiple visits ........................................................................................................................ 44  
9.3  
Drug study ............................................................................................................................ 45  
9.3.1 Definition and assessment of (serious) adverse events and other safety related events .... 45  
9.3.2 Reporting of serious adverse events (SAE) and other safety related events ...................... 45  
9.3.3 Follow up of (Serious) Adverse Events ................................................................................ 45  
9.4  
Medical Device Category C studies ......................................................................................... 45  
9.4.1 Definition and Assessment of (Serious) Adverse Events and other safety related events ... 45  
9.4.2 Reporting of (Serious) Adverse Events and other safety related events............................... 45  
9.4.3 Follow up of (Serious) Adverse Events ................................................................................ 46  
9.5  
Medical Device Category A studies ......................................................................................... 46  
9.5.1 Definition and recording of safety-relevant events ............................................................... 46  
9.5.2 Reporting of Safety related events ...................................................................................... 46  
9.5.3 Notification of a security-related event................................................................................. 46  
10 STATISTICAL METHODS .............................................................................................................. 47  
10.1 Hypotheses & Factors .................................................................................................................. 47  
10.2 Sample size .................................................................................................................................. 47  

  
  
  
  
  
  
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10.3  
Criteria for the statistical use of data in the case of incomplete data sets ................................ 47  
10.4  
Planned analyses .................................................................................................................... 47  
10.4.1 Datasets and Data Population ............................................................................................ 47  
10.4.2 Primary Analysis ................................................................................................................. 47  
10.4.3 Secondary Analysis ............................................................................................................ 48  
10.4.4 Interim analyses ................................................................................................................. 48  
10.4.5 Security Analyses ............................................................................................................... 48  
10.4.6 Deviations .......................................................................................................................... 48  
10.5  
Drop-outs and missing data ..................................................................................................... 48  
11 QUALITY ASSURANCE AND CONTROL ..................................................................................... 49 
11.1  
Data Archiving .......................................................................................................................... 49 
11.1.1 Forms.................................................................................................................................. 49 
11.1.2 Specification of Forms ........................................................................................................ 49 
11.1.3 Archiving the Data .............................................................................................................. 49 
11.2  
Data Management ................................................................................................................... 49 
11.2.1 Data Management System ................................................................................................ 49  
11.2.2 Data Security and Backup .................................................................................................. 49  
11.2.3 Analysis and Archiving ........................................................................................................ 49 
11.2.4 Validation of electronic data ............................................................................................... 50 
11.3 Monitoring ..................................................................................................................................... 50 
11.4 Audits and inspections ................................................................................................................... 50 
11.5 Confidentiality and data protection ................................................................................................ 50 
11.6 Retention of biological material and health-related data .............................................................. 50 
12 PUBLICATION AND DISCLOSURE OF DATA .............................................................................. 51  
14 FUNDING AND SUPPORT ............................................................................................................ 52  
14.1 Financing .............................................................................................................................. 52 
15 INSURANCE ................................................................................................................................... 53  
16 REFERENCES ............................................................................................................................... 54  
  
 

  
  
  
  
  
  
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Study Synopsis   
 
  
Sponsor/  
Sponsor- 
Investigator  
Sponsor   
Thim van der Laan AG Thim 
van der Laan jr.  
Weststrasse 8 / CH-7302 Landquart   
  
Investigator  
Dr. Clijsen Ron, PhD  
University of Applied Sciences and Arts Southern Switzerland (SUPSI)  
Department of Business Economics, Health and Social Care  
Physiotherapy Graubünden   
Weststrasse 8 / CH-7302 Landquart  
Study Title:  
Clinical trial study to investigate the effectiveness of the patello  
Short Title / Study 
ID:  
Effectiveness study Patello  
Protocol 
Version 
and Date:  
Version 01 from 05.04.2018  
Trial registration:  
Cantonal Ethics Committee Zurich   
Study 
category 
and Rationale  
Clinical trial with a medical device of risk category C according to ClinV (Art. 20)  
The device under investigation, Patello, is an innovative product for passive, 
continuous mobilization of the patella. It consists of CE certified  
Individual components. As a complete device, the Patello is not yet CE 
certified.  
Clinical Phase:  
The Patello device will be tested for its effectiveness in this clinical trial before 
the clinical phase begins.  

  
  
  
  
  
  
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Background and 
Rationale:  
Restricted movement of the knee joint hinders the everyday life of the affected 
person. They can be caused by osteoarthritis or after surgical procedures on 
the knee joint. The therapy of choice for limited knee mobility is the active and 
passive mobilization of the knee joint  
(Art. Genu, Art. Patellofemorale, Art. Tibiofibulare) with involvement of the soft 
tissue mantle (muscles, connective tissue). Active mobilization is carried out by 
the patient independently through a specific exercise program. Passive 
mobilisation is part of physiotherapeutic treatment. The aim of mobilisation is 
to activate the formation of synovial fluid, to regulate the tone of the muscles 
and to influence the fibre alignment of the collagen tissue.   
The Patello device was built to perform passive, continuous mobilization of the 
patella as part of rehabilitation with limited knee mobility. The area of application 
and indication is based on the widely used "Kinetec" knee and hip mobilisation 
splint. What is innovative about the Patello is that only the Art. patellofemoral is 
mobilized; the patella is moved on its plain bearing in the cranial and caudal 
directions.  
Objective(s):  
The aim of this clinical trial is to prove the effectiveness of the patello.  
Outcome(s):  
Primary outcome: Objectification of the displacement of the patella to cranial 
and caudal measurement with an imaging ultrasound device (esaote 
MyLabClassicC, Genoa, Italy, www.esaote.com).  
Secondary outcome: Subjective well-being of the subject measured by a visual 
analogue scale (VAS scale 0 - 10).  
The knee to be tested is determined by lot (randomized) per test person. The 
outcomes are recorded after 1, after 10, after 20, after 30 and after 50 
mobilizations in the caudal deposition position. The entire measurement 
procedure is carried out 2x in a week per test subject with a 2-day break in 
between.   
Study design:  
Clinical effectiveness study  

 
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Inclusion/  
Exclusion criteria:  
  
Inclusion Criteria:  
- 
Adults aged 18 to 30 years  
- 
No surgical interventions and/or current complaints  
(pain at rest or during exertion) on the musculoskeletal apparatus in 
the area of the lower extremities  
- 
closed, intact skin conditions in the knee and thigh area  
- 
Don't be afraid of the intervention  
  
Exclusion criteria:  
- 
Adolescents and adults over 30 years of age  
- 
Surgical interventions and/or current complaints (pain at rest or during 
exertion) on the musculoskeletal apparatus in the area of the lower 
extremities   
- 
No closed, intact skin conditions in the knee and thigh area  
- 
Fear of intervention  
Preparation  
Subject recruitment  
The study is being advertised internally at the University of Applied Sciences 
and Arts Southern Switzerland SUPSI. Interested parties report to the study 
director in the research laboratory, who gives them the written subject 
information and the declaration of consent to read at home. The principal 
investigator verbally explains the objective, procedure and conditions of the 
study. If the interested party wants to participate in the study, he or she brings 
the signed declaration of consent to the research manager, who also signs it. If 
there is any ambiguity on the part of the interested party, questions can be 
asked at any time. A copy is given to the future test subject. The health 
questionnaire is then filled out. This clarifies the inclusion and exclusion criteria. 
If all inclusion criteria are met, the test subject draws a lot to determine the side 
to be tested. Afterwards, 2 appointments are arranged, which guarantee a 2-
day break between the measurements.  
  
Subject preparation   
The test subject wears shorts and is barefoot. He sits down on the treatment 
table. The backrest is raised so that an upright sitting position can be assumed. 
The leg to be tested is placed on the patello and fixed according to the product 
description (Chapter 8). The foot is placed underneath so that the leg can lie 
relaxed. In a first phase, the contact pressure of the device is calculated based 
on the well-being of the  
test subjects. The setting is noted.   

 
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Measurements and 
procedures:  
Measurement procedure   
This is followed by the 1st measurement (pre-mobilisation). Afterwards, the 
mobilization pressure is built up individually up to the tolerance limit of the test 
subject so that a displacement of the patella caudally takes place (2nd 
measurement). The maximum deflection of the patella to the reference point 
is determined and the device settings are noted. As described above, further 
measurements are carried out according to the following scheme: after 10 
mobilisations (3rd measurement), after 20 mobilisations (4th measurement), 
after 30 mobilisations (5th measurement), after 50 mobilisations (6th 
measurement).  
The device settings are kept the same for all measurements per subject.  
 
Objective Displacement  
The displacement of the patella due to mobilization is objectified by means of 
an imaging ultrasound device. In a second step, the distance of the patellar 
displacement is evaluated using the ultrasound images using special software 
(OsiriX, www.Osirix-viewer.com).   
 
Subjective information on general well-being  
After each measurement interval, the subjects report their subjective well-being 
using a visual analogue scale (VAS). The scale is from "0" (maximum well-
being) to "10" (maximum discomfort) in cm-  
steps.  
  
Further processing of the data  
Microsoft Excel from Windows is used for data pooling and the graphical 
representation of the end data.  
Study Product / 
Intervention:   
For this study, we use a device (Patello, Srm-Projects GmbH, Chur) that 
mobilizes the patella by apparatus, passively and continuously.  
Control  
Intervention (if 
applicable):  
There is no control intervention.  
Number of  
Participants with 
Rationale:  
We limit the number of subjects to n = 30. According to the g*power 
calculation, this gives us an effect size of 0.68 with a power of 0.95.  
  
Study Duration:  
June 2018 - December 2018  
Study Schedule:  
June 2018: planned start of measurements  
December 2018: planned end of measurements  

 
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Investigator(s):  
Examiner  
- 
Dr. Ron Clijsen1,2  
- 
Erich Hohenauer, Drs.1,2  
- 
Rahel Stoop, MSc1  
- 
Dr. Matthias Fenzl3  
1 
University of Applied Sciences and Arts Southern Switzerland SUPSI, Department of 
Business Economics, Health and Social Care, Physiotherapy Graubünden, Weststrasse 8, 7302 
Landquart  
2 
THIM University of Applied Sciences in Physiotherapy, Weststrasse 8, 7302 Landquart  
3 
Medical Center Bad Ragaz, Hans Albrecht-Strasse, 7310 Bad Ragaz   
  
Contact / Director of Studies  
Dr. Clijsen Ron, PhD  
University of Applied Sciences and Arts Southern Switzerland (SUPSI)  
Department of Business Economics, Health and Social Care  
Physiotherapy Graubünden   
Weststrasse 8, 7302 Landquart  
Phone: +41 81 300 01 75 
ron.clijsen@supsi.ch  
Study Centre(s):  
Single Centre Study:  
Rehabilitation Research Laboratory  
University of Applied Sciences and Arts Southern Switzerland SUPSI  
Department of Business Economics, Health and Social Care  
Physiotherapy Graubünden Weststrasse 
8  
7302 Landquart  
Statistical  
Considerations:  
Patellar displacement during mobilization application by the patello. Repeated 
measures analysis of variance (MANOVA)  
  
A 2-factor analysis is carried out.  
 Factor 1:  
Intervention Patello  
Factor 2: Time intervention: Start (pre-intervention, 1st measurement), after a 
single mobilization (2nd measurement), after 10 (3rd 
measurement), after 20 (4th measurement), after 30 (5th 
measurement), after 50 mobilizations (6th measurement).  
  
 
The significance level is set at P < 0.05, and distatistical data analysis is 
carried out using the Statistical Package for Social Sciences (SPSS V. 24) 
from IBM, New York, USA.  

 
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GCP Statement:  
This study will be conducted in compliance with the protocol presented here, 
the current version of the Declaration of Helsinki, the ICH-GCP, ISO EN 14155 
(where applicable), and the Swiss Human Research Ordinance HFV.  
 
 

 
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Overview of the study   
 
Knee joint mobility can be limited by arthritic or post-operative functional or structural changes. Reduced 
knee joint mobility can interfere with the affected person's everyday activities. Active movement of the 
knee promotes the formation of synovial fluid, which is essential for the supply of cartilage tissue. Passive 
mobilization techniques as part of a physiotherapeutic treatment release structural blockages and favor 
the fiber alignment of the collagen tissue.   
In order to provide a further passive mobilisation option of the knee joint, specifically Art. Patellofemoral 
device, independent of therapists, the Patello device was developed. It performs apparatus, passively 
and continuously mobilization of the patella in the caudal and cranial directions. The movement 
deflections are determined by the patient independently based on the current tolerability.  
  
Aim of the study  
The aim of this study is to determine the effectiveness of the Patello device. We want to prove that the 
Patello device moves the patella on the patellofemoral bearing.   
The primary outcome is the objectification of the displacement of the patella measured with an imaging 
ultrasound device (esaote MyLabClassicC, Genoa, Italy, www.esaote.com).  
As a secondary outcome, the subjective well-being of the subject is recorded, measured using a visual 
analogue scale (VAS scale 0 - 10).  
In order to record a possible positive effect of repetitive mobilization, the measurements are carried out 
several times: after the positioning of the device (1st measurement, pre-mobilization), after 1 
mobilization, after 10 mobilizations, after 20 mobilizations, after 30 mobilizations and after 50 
mobilizations (2nd to 6th measurement). The measurements are carried out on 2 days, with a 2-day 
break in between.   
  
  
  
Abbreviations  
  
CEC  
Competent Ethics Committee  
GCP  
Good Clinical Practice   
KlinV  Ordinance on Clinical Trials in Human Research Study Schedule   
 
The completion of the measurement series is planned for December 2018, and the completion of the 
entire project for December 2019.  
  
Table 1: Schedule  
  
June, 2018  
July-December, 2018  
January-May, 2019  
June-December, 2019  
Subject Information, 
Screening, Planning  
Data collection and  
Statistics   
Writing the article   
Publishing the article   

 
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1  
STUDY ADMINISTRATION  
 
1.1  
Sponsor   
Thim van der Laan AG 
Thim van der Laan jr.  
Weststrasse 8 / CH-7302 Landquart  
+41 81 300 01 70  
t.vanderlaan@physioschule.ch  
  
1.2  
Investigator  
Dr. Clijsen Ron, PhD  
University of Applied Sciences and Arts Southern Switzerland SUPSI  
Department of Business Economics, Health and Social Care  
Physiotherapy Graubünden   
Weststrasse 8, 7302 Landquart  
+41 81 300 01 75  
ron.clijsen@supsi.ch  
  
1.3  Examiner  
  
Investigator  
Dr. Ron Clijsen1,2 (PhD, GCP Module I – III & GCP Basic Course, Advanced Course Sponsor-
Investigator)  
University of Applied Sciences and Arts Southern Switzerland SUPSI  
Head of Research at the Department of Business Economics, Health and Social Care  
Weststrasse 8, 7302 Landquart  
Phone: 
+41 
81 
300 
01 
75 
ron.clijsen@supsi.ch  
Selection of test subjects, obtaining consent to participate in the study, study administration, carrying out measurements – 
collecting data, data analysis, interpreting the data, writing the report  
  
Other examiners  
Rahel Stoop, MSc1 (GCP Module I-III & GCP Basic Course)  
Selection of subjects, obtaining consent to study participation, study administration, implementation of the  
Measurements – collecting the data, analyzing the data, interpreting the data, writing the report Erich 
Hohenauer, Drs, MSc1.2 (GCP Module I-III & GCP Basic Course)  
Selection of test subjects, obtaining consent to participate in the study, study administration, carrying out measurements – 
collecting data, data analysis, interpreting the data, writing the report  

 
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Dr. Matthias Fenzl3 (PhD, GCP Module I-III)  
Data analysis, interpretation of the results, writing of the report  
  
  
1 University of Applied Sciences and Arts Southern Switzerland SUPSI, Department of Business Economics, Health and Social 
Care, Physiotherapy Graubünden, Weststrasse 8, 7302 Landquart  
2 THIM University of Applied Sciences in Physiotherapy, Weststrasse 8, 7302 Landquart  
3 Medical Center Bad Ragaz, Hans Albrecht-Strasse, 7310 Bad Ragaz  
  
Other employees none  
  
1.4  Statistician  
Erich Hohenauer, Drs.  
University of Applied Sciences and Arts Southern Switzerland SUPSI  
Research Associate in the Department of Business Economics, Health and Social Care  
  
Weststrasse 8, 7302 Landquart  
  
+41 81 300 01 75  
erich.hohenauer@supsi.ch  
  
1.5  Head of the Research Laboratory (Investigator)  
Dr. Ron Clijsen, PhD  
University of Applied Sciences and Arts Southern Switzerland SUPSI  
Department of Business Economics, Health and Social Care   
  
Weststrasse 8, 7302 Landquart  
  
+41 81 300 01 75  
ron.clijsen@supsi.ch  
  
1.6  
Monitoring of the study  
Prof. Dr. Peter Clarys4  
  
"Vrije Universiteit Brussel"   
Faculty of Physical Education and Physiotherapy   
Pleinlaan 2, 1050 Brussels, Belgium  
  
peter.clarys@vub.ac.be  
4Vrije Universiteit Brussel, Faculty of Physical Education and Physiotherapy, Pleinlaan 2, 1050 Brussels, Belgium  
  

 
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1.7  
Privacy  
All data obtained from study participants will be coded and not passed on to other people. Personal data 
and personal details are stored in paper form in a locked filing cabinet. The head of the research 
laboratory and at the same time the head of the study has access here, and the administration of the 
documents also falls within his area of responsibility.  
All digital data is encrypted and encoded. No conclusions can be drawn about individuals. The digital 
data is stored on internal computers, archived and not released to outsiders.  
Employees involved in data processing have no insight into the personal data and the coding of it.  
  
1.8  
Other committees or institutes involved   
The study is being conducted in the research laboratory at the University of Applied Sciences and Arts 
Southern Switzerland SUPSI, Department of Business Economics, Health and Social Care 
Physiotherapy Graubünden, Weststrasse 8, 7302 Landquart, Switzerland.  
The measuring equipment is all located in this room, so all measurements can be carried out at the same 
location. The room offers enough space.  
At present, no further studies with this arrangement are taking place in this experimental laboratory. 
Another study is currently taking place at our institute (NCT 03016221). However, the measurements of 
these studies do not take place at the same time and do not hinder or influence each other. Thus, the 
utilization of the infrastructure is not excessive and therefore justifiable.  
  
No other institutes and committees are involved in this study or in the approval or monitoring of the study.   
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

 
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2  
ETHICAL AND REGULATORY ASPECTS  
 
2.1  
Study Registration  
The conduct of the present study is the responsibility of the Cantonal Ethics Committee Zurich and 
Swissmedic, as it is a category C medical device (pre-market). An application for admission is submitted 
to both institutions. Any further conditions imposed by the responsible ethics committee and/or 
Swissmedic must be implemented in the study protocol.  
When the study protocol is submitted to the Cantonal Ethics Committee in Zurich, the study is also 
registered with the Swiss Coordination Office for Research on Human Subjects.  
  
2.2  
Categorization of the study   
The study is categorized as a clinical trial with a medical device of risk category C (ClinO, Art. 20). The 
test subjects are not administered medication or tissue samples are taken. No invasive methods are 
used.  
  
2.3  
Competent Ethics Committee (CEC)   
Human research in the Canton of Graubünden falls under the remit of the Cantonal Ethics Commission 
Zurich. Changes to the study protocol are not permitted without the prior consent of the CEC, except for 
the immediate elimination of obvious hazards to the participants. According to chap. 2.10 to the CEC.  
An early termination or interruption of the study must be reported to the CEC within 15 days, and the 
regular end within 90 days. The final report must be submitted within one year of the end of the 
programme. Corrections are to be reported in accordance with Chapter 2.10.   
  
2.4  
Competent Authorities (CA)   
The present study falls under the remit of the Cantonal Ethics Committee Zurich. Obligations and 
deadlines can be found in the previous point.  
  
2.5  Ethical Leadership of the Study  
The study will be conducted in accordance with this protocol and the current version of the Helsinki 
Declaration, the ICH-GCP, the European Medical Device Directive 93/42/EEC and the ISO standard 
14155 and ISO 14971 (where applicable), as well as the Swiss Human Research Ordinance and thus 
Swiss law.  
The CEC receives an annual report and is informed about the course of studies.   
  
2.6  
Conflict  
There is no financial conflict of interest on the part of the sponsor/investigator, nor is there a 
corresponding relationship of dependency.  
  

 
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2.7  
Patient information and informed consent  
The examiners will explain to each participant individually the nature of the study, its content, intent and 
objective. This includes the protocol flow, approximate time duration, possible risks and benefits. The 
participant is informed that participation is voluntary and can be withdrawn from the study at any time, 
without personal consequences of any kind. The participant will be informed about data protection, the 
handling of personal data and their access.  
Each participant receives written subject information and the declaration of consent with the detailed 
study description and all necessary information to be able to decide whether to participate in the study. 
The participant will also be given sufficient time to read this written information and to ask questions to 
the responsible examiners.  
The subject information and the informed consent form are submitted to the CEC, where they must be 
reviewed and approved.   
The signed declaration of consent must be submitted before the start of the study process. The 
participant should read them before signing and check their contents. The responsible examiner then 
also signs the declaration of consent. Finally, the participant receives a copy of the declaration of consent. 
The signed declaration of consent is kept in the original as a study document in a locked filing cabinet.  
  
2.8  
Confidentiality & Privacy  
The examiners ensure that the privacy of the participants is maintained. In particular, data protection and 
confidentiality are guaranteed, and no personal data is presented or published. The signed declaration 
of consent, as well as the completed questionnaire with the other personal details, are kept in the original 
as a study document in a locked filing cabinet.  
The digital data is encrypted and treated confidentially, and access to the personal data is denied to third 
parties. The digital data collected is stored solely on the institute's own computers and is not passed on 
to any external persons or transferred to other computers.  
Direct access to the personal data is allowed only to the head of the research laboratory (study leader), 
as well as authorized persons of the CEC.  
  
2.9  
Early termination of the study   
The sponsor or principal investigator may discontinue the study early if/if  
- 
ethical concerns  
- 
insufficient number of subjects  
- 
the safety of the participants cannot be guaranteed  
- 
Findings from clinical practice make it pointless to continue the study  
- 
early evidence or harm of the experimental intervention has been proven  
  
2.10 Protocol Adjustments  
Adjustments and changes to the current study are only permissible after review by the CEC and 
Swissmedic. Short-term changes to the protocol before a review by the CEC and Swissmedic can be 
made to ensure the rights and safety of the participants. However, such adjustments must be 
documented and reported to the CEC and Swissmedic as soon as possible.  

 
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Significant changes are only permissible after an examination by the CEC and Swissmedic. Any other 
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3  
BACKGROUND AND RATIONALE   
 
3.1  
Background and justification  
3.1.1    
Physiology – Elastoplastic tissue properties (tissue treatment area of the knee)  
Painful restriction of mobility is nothing unusual after surgical interventions on the knee joint. Collagen 
resynthesis plays a decisive role in the healing process. It is characterized by tissue remodeling. It is not 
uncommon for the recovery phase to be delayed, which has a negative effect on knee mobility. 
Permanently restricted knee mobility leads to structurally shortened periarticular tissues. In about 10% 
of patients, the periarticular tissue remains permanently altered, limiting joint mobility. Early signs of 
structurally induced hypomobility are often adhesions of connective tissue, excessive connective tissue 
formation or the formation of pathological crosslinks (collagenous cross-connections).   
Knowledge of the indicators and the recognition of delayed healing processes is important in order to 
exert targeted structural and form-forming stimuli on the collagen tissue at an early stage. The 
standardised procedures include intensive passive and active mobilisation.  
In this study, the collagen soft tissue sheath of the kneecap is to be mobilized in a targeted manner, 
which is why the further explanations of the repair process refer to the anterior knee joint compartment.  
From a biophysical point of view, the collagen fibrils of ligaments and tendons are stretched and stretched 
during mobilization. The change in length of the tendinous tissue is attributed to elastic, plastic and 
viscous properties. Elasticity refers to the strain-stress curve on tensile load. Plasticity is equated with 
mold elongation and viscosity with shape change due to flow properties. While the muscle can be 
stretched to 160% of its resting length with over 70% wet mass (water, sarcoplasm), the elasticity of the 
tendon with 30% wet mass is only between 4% and 10% of its initial length (Hüter-Becker, 1997).  
Tendon tissue has only a low elasticity, but a high resistance (stiffness). As tensile stress increases on 
the tendon tissue, more and more fibers counteract the tension. The high resistance of tendon tissue is 
based on the arrangement of collagen fibers in bundles, and the cross-linking of proteoglycans in the 
collagen matrix (Jakob, 1990).   
In the experimental situation in the laboratory, tendons were lengthened by exposing them to a constant 
tensile load in order to investigate the viscoelastic properties of tendinous tissue. This process is called 
"creep" and can be observed even when the forces acting on it are low. The physiological stretching 
loads did not lead to permanent deformities or damage to the tendons if the tendon was given enough 
time to stretch (Wilcke, 2004). The creep phenomenon observed in laboratory situations is also observed 
in cyclic long-term stimulus loads such as in endurance disciplines, whereby the tendons and ligaments 
recover after cyclic conditioning and return to their initial length (Van den Berg, 1999).  
The high plasticity and viscosity of tendon tissue is used in surgical practice for the preparation of tendon 
tissue. For use as an autologous graft, the tendons are subjected to a defined deformity. The tendons 
are stretched for 5 minutes under a defined tensile force in order to expand the collagen fibers in a 
targeted manner and align them parallel. Cyclic preconditioning or pre-tensioning of the quadriceps, 
patellar and semitendinosus tendons has proven to be useful in order to maintain the graft its intended 
length after installation. Even more than the quadriceps tendon, the patellar tendon benefits from 
conditioning in terms of tear resistance (Schatzmann, 1998).   
  
These examples show that a targeted tensile force in the grain course on tendons is essential to achieve 
a functional parallel fiber arrangement and resistivity. Obviously, repeated stimulation can restore the 
normal length ratio and also increase tissue tolerance.  

 
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Efficacy studies have shown that static and dynamic tension-specific stimuli change the biomechanical 
properties of the tendinous system.   
According to Salter (1989), the alignment of collagen fibers in tendons and ligaments changes as a result 
of the regular load following the mechanical force. Under tensile and compressive stress of connective 
tissue structures, the crosslinks unfold in a physiological mass and thus contribute to the stabilization of 
filamentary structures. Induced by the mechanical stress stimulus, fibroblasts synthesize more 
procollagen, which serve as the basic building block of collagen fibers. In fibril synthesis, the collagen 
arrangement is aligned with the effective lines of force of the practicing stimulus.  
At the tissue physiological level, the connective tissue is metabolically active in targeted, longer-lasting 
stretching stimuli. As a result of the increased collagen turnover and its beneficial influence on collagen 
metabolism, the tissue can adapt to the load in the long term (Cook, 2002).   
  
3.1.2    
Indications for instrumental kneecap mobilization  
3.1.2.1 Arthrofibrosis (AF) of the knee joint  
AF is one of the most feared complications after surgical procedures on the knee joint and is caused by 
excessive tissue formation. Pathologically, AF is an increase in connective tissue cells (fibrocytes) that 
leads to intra-articular adhesions and scarring. The anterior knee joint is most commonly affected, 
accompanied by restricted movement of the anterior joint compartment (Robertson, 2008). 
Pathophysiologically, primary AF must be distinguished from the secondary form:  
AF accumulate intra-articular molecules of the extracellular matrix in the context of impaired wound 
healing (Faust, 2015). In the secondary form, there is mechanical irritation, and in some cases there are 
symptoms of entrapment. The majority of AF is more common than anterior and less common than 
generalized (Paulos, 1995). Anterior AF is accompanied by extensor inhibition due to adipose body and 
retinaculum fibrosis (infrapatellar contraction syndrome, patella entrapment), while generalized AF often 
leads to hypomobility of the entire knee joint due to fibrosclerosing scarring.  
Following the guidelines in the treatment of secondary arthrofibrosis, the periarticular collagen structures 
should be treated in a targeted manner by intermittent mobilization. Intermittent tensile loads release 
collagenases in proliferative fibrous hyperplasia. They are able to break up collagen adhesions and 
pathological crosslinks. Tissue collagenases cleave collagen molecules. The resulting fragments are 
degraded by non-specific proteases down to the individual amino acids (Gelse, 2003).   
In the rather rare cases of primary AF with dysfunction of reparative processes and the biology of 
fibroblasts, the dysregulated sympathetic nervous system is held responsible. The risk of sympathetic 
reflex dystrophy is particularly high after knee joint replacement (total endoprosthesis, TEP) and after 
replacement of the anterior cruciate ligament. The enzymes responsible for the excessive formation of 
connective tissue must not be exacerbated by mechanical stimuli and pain. In these cases, specific 
mobilisation is dispensed with. The  
Intervention is limited to reflex therapy measures to dampen fibroblast activity and sympathetic tone: 
slight movement within the pain-free range is indicated, additional drug treatment with low-dose 
prednisolone and propanolol (Traut, 2012). For the desired treatment success, the ligamentary and 
capsular structures of the anterior knee must be addressed in a differentiated manner in the case of 
anterior AF or stiffening.  
  
3.1.2.2 Knee endoprosthesis   
The indication for the use of a bicondylar sled prosthesis or knee TEP is specified by the surgical side, a 
surgical intervention or joint replacement is carried out in the case of preoperative osteoarthritis from a 
severity grade III according to WHO criteria.  
A not uncommon complication after knee replacement is persistent restriction of mobility. From a clinical 
point of view, mobility is limited with an extensor or flexion deficit of more than 10° or 15° to the opposite 

 
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side (Nwachukwu, 2011; Kim, 2004), although the definition is inconsistent and often oriented towards 
function.  
In reviews and large cohort studies, the incidence of knee hypomobility after knee replacement is 
reported to be 1.3% to 5.3% (Kim, 2004; Yercan, 2006; Gandhi, 2006).  
The reasons for a movement deficit are multifactorial, and the etiology and pathogenesis are sometimes 
insufficiently understood (Manrique, 2015). Most often, the femorotibial joint is affected. In only 12% of 
complex cases, the extensor apparatus or the patellofemoral joint is involved (Nam, 2004). The 
problems, also referred to as the extensor mechanism, are based on various causes in the differential 
diagnosis: patellar maltracking, rupture of the extensor mechanism (patellar fracture, patellar and 
quadricle tendon rupture), patellar joint surface problems (lateral facet impingement with undersized 
patellar posterior replacement, unreplaced patellar posterior replacement, posterior surface replacement 
that is too thick, arthrofibrosis (AF), patella alta and baja (Mandalia, 2008).  
In most cases, persistent hypomobility of the knee joint is surgically arthrolytically addressed  
(Schairer, 2014). The indication for mobilization under anesthesia or arthroscopic arthrolysis is usually 3 
months postoperatively (Manrique, 2015) with an extension/flexion deficit of 20°, retrospectively 40° 
(Tröger, 2014). The number of cases with AF is reported in various studies with strongly fluctuating figures 
of 1.2 to 17% (Schiavone, 2009 ). AF is one of the most common reasons for revision surgery (Schiavone, 
2009). In two recent large multicenter cohort studies (Schroer 2013; Lombardi, 2014) and in a 
retrospective survey (Huang, 2015), incidence rates of 6.9% to 10% were reported. There are many 
reasons for revision surgery, often due to mechanical causes such as adhesions and scar tissue, and 
primary AF (also known as dystrophy or vegetative dysregulation) is rarely seen (Tröger, 2014).   
The analysis shows that, according to current data, there is a high risk of the persistence or occurrence 
of movement restrictions. The anterior knee joint is less frequently affected after implantation of a knee 
TEP. For a targeted treatment of the femoropatellar compartment, the cause must first be clarified by 
differential diagnosis. The kneecap mobilization must therefore be addressed to persistent mobility 
restrictions of the femoropatellar plain bearing.  
After knee TP with patellar replacement, the occurrence of femoropatellar problems is far more common. 
Barrack (1997) and Campbell (2006) estimate complications with a prevalence of up to 50%. The causes 
are a greater contact pressure load due to a small contact surface (Stukenborg, 2003) and higher shear 
forces (Singerman, 1999) due to dysfunctional guidance of the medial and lateral patellomensicealia 
ligaments, which finely control the movement of the patella. In this respect, retropatellar replacement is 
controversially discussed.  
  
  
3.1.2.3 Fractures near the joint and tibial head realignments  
Adhesion of the synovial membranes is particularly often seen after osteosynthetic treatment after 
fractures of the tibial head or kneecap (expert opinion: personal communication from orthopaedic 
surgeons at the Gut Clinic, St. Moritz). The soft tissue sheath is then less easy to move and it is not 
uncommon for a patella baja (deepening of the patella) to develop. This also explains why a restricted 
caudal-cranial movement component is most commonly seen.  
  
3.1.2.4 Replacement of the anterior cruciate ligament (ACL)  
Soft tissue-related movement restrictions of the knee joint are often found after surgical interventions. 
Many of these fibrosed knee joints affect the Hoffa's fat body or retinacula, which leads to limited mobility 
of the entire knee joint due to scarring (Mayr, 2008; Mayr 2014). From the abundance of studies on 
suitable replacement plastics, it has been shown that the Lig. patellae is suitable for marcoscopic reasons 
(ultrastructure, remodeling) (Jakob, 1990). The unfavorable findings of the extensor apparatus are to be 
commented on. In general, good stabilization performance was achieved, but new problems were 

 
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created in the anterior knee joint (scarring in the donor area, especially in the area of Hoffmann's fat 
body). Rosenberg (1990) pointed this out early on. A review of the recent literature shows that today the 
quadriceps or semitendinosus tendon are preferred as transplants and that the symptoms of 
femoropatellar pain syndrome are therefore seen less frequently.   
  
3.1.3   
Repetitive Strain Stresses  
3.1.3.1. Motorized Motion Rails (CPM)  
Motorized motion splints are of great importance in the postoperative early rehabilitation phase with 
limited joint mobility. Intermittent dynamic mobilizations provide specific chronic stretching stimuli and 
trigger structural adjustments of the plastic tissue. Motorized motion splints for continuous movements 
are therefore firmly anchored in the guidelines of medical professional associations for the follow-up 
treatment of fractures close to the joint, for tibial head realignments, after ACL replacement and other 
indications.  
The use of motion splints is considered useful and indispensable due to the state of knowledge in joint 
hypomobility and in the early stages of the postoperative healing process such as bleeding, granulation 
tissue, oedema and generally in soft tissue-related movement restrictions (fibrosis) (Milne, 2003; Haller, 
2015). However, the therapeutic benefit of motorized motion splints (CPM) is also controversially 
discussed with regard to the long-term healing process (Lenssen, 2008; Harvey, 2014; Herbold, 2014). 
In more recent studies, the developmental trajectories of movement deficits initially progress faster with 
CPM application, but the effect levels out over longer observation periods.  
  
3.1.3.2. Manual therapy  
Treatment  
Connective tissue  
Structures  
of 
 
anterior knee joint  
Manual techniques, such as those used in physiotherapy, improve the displacement of ligamentous 
components (Figs. 1 – 3). A finely balanced ligamentary system controls the sliding and displacement 
movements of the patella in the trochlea (Kyung, 2008). Both longitudinal tensile forces of the quadriceps 
and patellar tendon, as well as tensile forces of the lateral retinacula, which act in the transverse 
direction, have a load-balancing function. By directing the patella in the femoral groove, they compensate 
for the incongruities of the cartilage surfaces and distribute the forces over a large cross-section.  
It should be added that after a knee TEP, the medial or lateral  
Kneecap mobilization has no effect on knee function (Ota, 2010).  
In the case of structural movement restrictions, only slightly - especially in the case of pathological 
adhesion of the capsular fold - should be entered into the tissue resistance (Hüter-Becker, 2009), without 
provoking pain, so as not to trigger a sympathetic reflex dystrophy (Faust, 2015). The movement sector 
is continuously adjusted to the current pain threshold in order to achieve a maximum range (amplitude).  
  
  

 
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Fig. 1: Joint technique for femoropatellar stress pain with increasing knee flexion due to reduced sliding 
of the patella and translational movement in the tibiofemoral joint.  
  
  
Fig. 2: The knee is bent while the examiner exerts light pressure on the patella with one hand.  
  
  
Fig. 3: The knee is extended and the examiner moves the patella alternately from proximal to distal or 
lateral and medial under light pressure (low retropatellar compression) with limited sliding function 
(Winkel, 1985).  
  
Aim of the study  
The aim of this study is to determine the effectiveness of the Patello device. We would like to provide 
evidence of a displacement of the patella in the caudal / cranial direction by the Patello device.   
The primary outcome is the objectification of the displacement of the patella measured with an imaging 
ultrasound device (esaote MyLabClassicC, Genoa, Italy, www.esaote.com).  
As a secondary outcome, the subjective well-being of the subject is recorded, measured using a visual 
analogue scale (VAS scale 0 - 10).  
In order to record a possible positive effect of repetitive mobilization, the measurements are carried out 
several times: after the positioning of the device (1st measurement, pre-mobilization), after 1 
mobilization, after 10 mobilizations, after 20 mobilizations, after 30 mobilizations and after 50 
mobilizations (2nd to 6th measurement). The measurements are carried out on 2 days, with a 2-day 
break in between. The settings are redefined per measurement day, but are maintained during 
measurements 1-6 to guarantee comparability.  
  
3.2  
Medical product and indication  
The Patello is a device for "Continuous Passive Motion" (CPM) of the patella. It grips the kneecap and 
mobilizes it in the caudal / cranial direction. Among other things, the system supports rehabilitation in the 
event of limited mobility of the knee joint, such as knee surgery (see Chapter 3).  
The most important components of the Patello are highlighted in the following image:   

 
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1. Knee brace   
2. Switch panel   
a. Slot for power plug   
b. On/Off Switch   
c. Reset button   
3. Knee brace   
4. Handheld control unit with emergency stop switch   
5. Essay   
a. Patellar Gripper  
b. Display   
c. Air cushion   
6. Lifting columns  
  
  
Handling Patello  
  
1. To turn on the Patello:   
Press the red on/off switch on the switch panel. The device will start initializing. After initialization is 
complete, the device switches to teaching mode (visible on the display).  
  
2. Moving the grippers:  
Press the "Grip" button on the hand control unit. The grippers move together until they grasp the patella 
from caudal and cranial.  
  
Fig. 4:  Patello  
 

 
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Fig. 5: Handheld control unit  
  
3. Operate and release the emergency stop: Switch the emergency stop toggle switch on the handheld 
control unit to "O". The grippers relax and the display shows the emergency stop mode. Switch the 
emergency stop toggle switch back to "I". Press the reset button on the switch panel.  
  
Fig. 6: Emergency stop toggle switch  
3.3  
Preclinical evidence  
See Chapter 3.1 above.  
  
3.4  
Current clinical evidence  
To the knowledge of the authors, there are currently no studies that have investigated apparatus-based, 
passive continuous mobilization in the caudal / cranial direction of the patella. The majority of existing 
studies are limited to the effect of manual therapy interventions (see 3.1 Background and Rationale 
below).  
  
3.5  
Medical product: method of application in the study   
As part of this clinical study, the displacement of the patella in the caudal / cranial direction by the Patello 
device will be recorded and quantified. This is to prove the effectiveness of this device. For more detailed 
specifications, see Chapter 3.2 Medical Device and Indication.  
  
3.6  
Intervention Patello  
In order to record a possible positive effect of repetitive mobilization, the measurements are carried out 
several times: after the positioning of the device (1st measurement, pre-mobilization), after 1 
mobilization, after 10 mobilizations, after 20 mobilizations, after 30 mobilizations and after 50 
mobilizations (2nd to 6th measurement). The measurements are carried out on 2 days, with a 2-day 

 
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break in between. The settings are redefined per measurement day, but are maintained during 
measurements 1-6 to guarantee comparability.  
  
The exact procedure for the measurements can be seen in Chapter 9.2.   
  
Randomization  
The allocation of the application page will be randomly assigned by lot.  
  
3.7  
Risk / Benefits  
The possible occurrence of risks from the use of the Patello is to be assessed as small: short-term skin 
irritations and/or paraesthesia could occur.   
The subjects do not benefit from participating in the study. The study serves to prove the effectiveness 
of the Patello device. If this is the case, the device can be used in the rehabilitation process of patients 
with the above-mentioned knee joint problems.  
Justification of the choice of population   
This series of studies will be conducted with healthy adults to assess the extent of the  
Quantify displacement of the kneecap by means of the patello.  
  
Table 1: Overview of inclusion and exclusion criteria  
Inclusion Criteria  
Exclusion criteria  
- 
Adults aged 18 to 30  
Years  
- 
No surgical interventions and/or current 
complaints (pain at rest or during 
exertion) on the musculoskeletal 
apparatus in the area of the lower 
extremities  
- 
closed, intact skin conditions in the knee 
and thigh area  
- 
Don't be afraid of the intervention  
- 
Adolescents and adults over 30 years of 
age  
- 
Surgical interventions and/or current 
complaints (pain at rest or during 
exertion) on the musculoskeletal  
Apparatus in the area of the lower 
extremities   
- 
no closed, intact  
Skin conditions in the knee and thigh 
area  
- 
Fear of intervention  
  
The test subjects are comprehensively informed about the course of the study and possible risks before 
they are accepted to participate in the study. You will also receive the information in written form and 
have the opportunity to ask questions if anything is unclear. The declaration of consent explains to them 
what their rights and obligations are when participating. In addition, they are informed that they may 
withdraw from participation at any time without giving reasons, without incurring any disadvantages as a 
result.  
  
4  STUDY OBJECTIVES   
 

 
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4.1  General objectives  
The aim of this study is to measure the effectiveness of the Patello device. It is designed to move the 
patella on its plain bearing in the caudal / cranial direction, passively and continuously. However, it is still 
unclear whether and to what extent the displacement of the patella is effective.  
  
4.2 Primary objectives  
A primary and secondary outcome was defined as the primary goal. The primary outcome, the 
displacement of the patella, detected by an imaging ultrasound device (esaote MyLabClassicC, Genoa, 
Italy, www.esaote.com) and evaluated by a dedicated software (OsiriX, www.osirix-viewer.com), is 
represented in mm and is considered an objective parameter.  
The secondary outcome, the recording of the subjective well-being of the test person, is determined 
using a visual analogue scale (VAS scale 0-10) and reflected in the number of cm. It is considered a 
subjective parameter.  
  
4.3 Secondary Objectives   
Multiple measurements will be performed to detect a possible sustained and/or cumulative effect of 
patellar mobilization. The measurements are repeated 2x per week in the same week, with a break of at 
least 2 days, as described in chapter 4.2.  
4.4  
Other safety aspects (long-term)  
No short-term risks are to be expected from this study other than those discussed so far (see 3.7 Risks 
/ Benefits).  
  
  
5  
STUDY OUTCOMES   
 
5.1  
Primary outcomes  
A primary and secondary outcome was defined as the primary goal. The primary outcome, the 
displacement of the patella, detected by an imaging ultrasound device (esaote MyLabClassicC, Genoa, 
Italy, www.esaote.com) and evaluated by a dedicated software (OsiriX, www.osirix-viewer.com), is 
represented in mm and is considered an objective parameter.  
  
5.2  
Secondary outcomes  
Subjective information on general well-being  
The secondary outcome, the recording of the subjective well-being of the test person, is determined 
using a visual analogue scale (VAS scale 0 - 10) and reflected in the number of cm. The value "0" 
describes "maximum feeling of well-being", the value "10" a "maximum feeling of discomfort". The value 
is considered a subjective parameter.  
  
Security considerations  

 
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No further results are recorded that would serve safety.  
Discontinuation of the experiment is the responsibility of the examiner with regard to the subject's 
subjective feelings and expressions.  
If a test subject does not feel comfortable during the intervention according to his or her subjective 
assessments, he or she can discontinue the experiment and withdraw participation in the study without 
any disadvantages.  
  
6  
STUDY DESIGN   
 
Study design and justification  
  
This clinical effectiveness study investigates the effect of apparatus-based, passive mobilization of the 
patella. The group size is n = 30.  
  
Table 2: Study design  
Time  
Preparation  
Pre  
1 Mob.  
10 Mob.  
20 Mob.  
30 Mob.  
50 Mob.  
Time (min)  
  
5  
10  
20  
30  
40  
50  
Measurement  
  
1.  
2.  
3.  
4.  
5.  
6.  
Subject information  
X  
  
  
  
  
  
  
Consent  
X  
  
  
  
  
  
  
Demographics  
X  
  
  
  
  
  
  
Intervention   
  
  
X  
X  
X  
X  
X  
Ultrasound image  
  
X  
X  
X  
X  
X  
X  
Subj. Well-being   
  
X  
X  
X  
X  
X  
X  
  
6.1  
Method for minimizing influencing factors  
6.1.1  
Randomization   
Randomization is used to randomly determine the application side, left or right knee.  
  
6.1.2  
Blinding   
Blinding the test persons and/or the examiners is not possible with regard to the intervention.  
The implementation of the intervention and the measurements of the primary and secondary outcome 
parameters are not carried out by the same examiner.  

 
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The blinding of the statistician can be guaranteed, who has no access to the personal data of the test 
persons and is not present during the data collection.  
  
6.1.3  
Other Methods  
No other methods are used.  
  
6.2  
Procedure for unblinding (code break)   
There is no provision for the statistician to be blinded.  
  
6.3  
Procedure for unblinding (code break)   
Blinding is only permitted if an unforeseen incident or medical problems occur in a subject during or after 
completion of study participation, which may be attributable to participation in the study.  
  
  
 

 
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7  
POPULATION STUDIES   
 
7.1  
Inclusion Criteria  
Table 3: Overview of inclusion and exclusion criteria  
Inclusion Criteria  
Exclusion criteria  
- 
Adults aged 18 to 30  
Years  
- 
No surgical interventions and/or current 
complaints (pain at rest or during 
exertion) on the musculoskeletal 
apparatus in the area of the lower 
extremities  
- 
closed, intact skin conditions in the knee 
and thigh area  
- 
Don't be afraid of the intervention  
  
- 
Adolescents and adults over 30 years of 
age  
- 
Surgical interventions and/or current 
complaints (pain at rest or during 
exertion) on the musculoskeletal  
Apparatus in the area of the lower 
extremities   
- 
no closed, intact  
Skin conditions in the knee and thigh 
area  
- 
Fear of intervention  
  
7.2  
Recruitment and Screening  
  
Recruitment  
The study is being advertised internally at the University of Applied Sciences and Arts Southern 
Switzerland SUPSI. The exact texts have been prepared according to the checklist of the Cantonal Ethics 
Commission Zurich.  
  
As advertisements (text visible):  
•  
Facebook 
page 
of 
the 
SUPSI 
Physiotherapy 
Training 
https://www.facebook.com/supsi.physiotherapie/notifications/   
Screening  
Interested parties should contact the director of studies at the research office of the University of Applied 
Sciences and Arts Southern Switzerland (SUPSI) for an initial consultation. Interested parties will be 
informed about the conditions of participation, the content and procedure of the study, as well as the 
amount of compensation. If you are still interested, the written study information and the confirmation of 
consent will be handed out. Interested parties can read the written documents at their leisure and ask 
any questions. If you agree to the terms of the study and wish to participate in the study, bring the signed 
documents to the principal investigator. A copy of the signed declaration of consent (by the interested 
party and the study director) will be handed over to the interested party. The health questionnaire is then 
filled out, which clarifies the suitability of the interested party to participate in the study. If the inclusion 
criteria are met, the interested party has passed the screening and is admitted to participate in the study.  
  
7.3  
Group assignment  

 
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There will be no group assignment.  
  
7.4 Discontinuation of study participation  
If a participant withdraws from the study before the measurements have begun, the allocation lot is 
returned to the pot in a new envelope and a new participant is sought.   
If a participant is eliminated during the measurements, all data collected up to that point will be evaluated 
as far as possible and included in the data analysis (in accordance with Art. 9 ClinO). In this case, no 
new participant will be recruited to collect the missing records.   
The data will be stored encrypted with a code during the study period and evaluation of the data.  
The conditions for the termination of the experiment were described in chap. 5.4.   
Participants are not disadvantaged by discontinuing their participation in the study.   
 

 
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8  
STUDY INTERVENTION   
 
8.1  
Medical Device ID   
8.1.1  
Intervention product  
The Patello is a device for "Continuous Passive Motion" (CPM) of the patella. It grips the kneecap and 
mobilizes it in the caudal / cranial direction. Among other things, the system supports rehabilitation in the 
event of limited mobility of the knee joint, such as knee surgery (see Chapter 3).  
The most important components of the Patello are highlighted in the following image:   
 
1. Knee brace   
2. Switch panel   
a. Slot for power plug   
b. On/Off Switch   
c. Reset button   
3. Knee brace   
4. Handheld control unit with emergency stop switch   
5. Essay   
a. Patellar Gripper   
b. Display   
c. Air cushion   
 
Fig . 7:  Patello  
 

 
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6. Lifting columns   
  
Handling Patello  
  
1. To turn on the Patello:   
Press the red on/off switch on the switch panel. The device will start initializing. After initialization is 
complete, the device switches to teaching mode (visible on the display).  
  
2. Moving the grippers:  
Press the "Grip" button on the hand control unit. The grippers move together until they grasp the patella 
from caudal and cranial.  
  
Fig. 8: Handheld control unit  
  
3. Operate and release the emergency stop: Switch the emergency stop toggle switch on the handheld 
control unit to "O". The grippers relax and the display shows the emergency stop mode. Switch the 
emergency stop toggle switch back to "I". Press the reset button on the switch panel.  
  
Fig. 9: Emergency stop toggle switch  
  
Securing the test subjects  
Through the screening process (filling out the health questionnaire with examination of the inclusion and 
exclusion criteria), only subjects who are suitable for participation in the study are recruited. In this way, 
at-risk test subjects are identified at an early stage and are not recruited/included in the study.  
8.1.2  
Control intervention  
No control intervention is carried out.  
8.1.3  
Packaging, labeling and use  
n/a  
8.1.4  
Storage  

 
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When the patello is not in use, it is stored in a lockable cabinet.  
  
8.2  
Administration of the experiment   
Since no drugs or invasive methods are used, the experiment is not discussed further in chapter 8.2-8.4 
and only chapter 9 is referred to.   
8.2.1  
Experimental intervention   
The experimental intervention (repetitive passive mobilization of the patella in the caudal / cranial 
direction by the patello) will be carried out on the right or left leg according to randomization.  
8.2.2  
Control intervention  
There is no control intervention.  
  
8.3  
Dosage, application modification   
In a first phase, the device settings (contact and mobilization pressure of the patello) are adjusted based 
on the well-being of the test subject. The mobilization pressure is built up individually to the tolerance 
limit so that a displacement of the patella takes place. The selected intensities are noted and maintained 
during all measurements per subject.   
  
8.4  Adherence to the study intervention  
The test subjects are not unnecessarily distracted by the examiners or the study director with 
conversations. Communication is kept to a minimum, only study-related discussions are held in order 
not to influence the results and to ensure homogeneity.   
  
8.5  
Follow-up treatment of eliminated participants   
Data already collected from eliminated participants will be evaluated as far as possible and will be 
included in the data analysis of the study.   
There is no disadvantage for the participants if they discontinue their participation in the study and no 
further interventions are necessary for follow-up treatment.   
If study participation was discontinued due to an excessive reaction/injury occurring during study 
participation, this will be recorded and reported to the sponsor investigator (head of the research 
laboratory), who is also the study leader, and the supervisor of the study. If medical care is necessary, 
the report is forwarded to the business liability insurance of Thim van der Laan AG (Basler Versicherung) 
in order to ensure the appropriate follow-up treatment.   
  
8.6  Preventive measurements  
The questionnaire determines the eligibility to participate in the study by recording the inclusion and 
exclusion criteria.   
  
8.7  
Accompaniments  
No further side effects are expected from study participation.   

 
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8.8  
Liability  
The measurements take place exclusively in the research laboratory of the University of Applied 
Sciences and Arts Southern Switzerland SUPSI in Landquart. Thus, there is no transport of the apparatus 
used or the test subjects. Liability for transport is therefore not necessary.  
  
8.9  
Return of the medical device  
The Patello device is returned to the manufacturer at the end of the measurement period.  
  
 

 
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9  
STUDY STRUCTURE & EVALUATION   
 
9.1  
Schedule Study Protocol  
Table 4: Overview of the measurement process  
Time  
Preparation  
Pre  
1 Mob.  
10 Mob.  
20 Mob.  
30 Mob.  
50 Mob.  
Time (min)  
  
5  
10  
20  
30  
40  
50  
Measurement  
  
1.  
2.  
3.  
4.  
5.  
6.  
Subject information  
X  
  
  
  
  
  
  
Consent  
X  
  
  
  
  
  
  
Demographics  
X  
  
  
  
  
  
  
Intervention   
  
  
X  
X  
X  
X  
X  
Ultrasound image  
  
X  
X  
X  
X  
X  
X  
Subj. Well-being   
  
X  
X  
X  
X  
X  
X  
  
9.1.1  
Measurement of primary and secondary outcomes  
The primary outcome, the displacement of the patella, detected by an imaging ultrasound device (esaote 
MyLabClassicC, Genoa, Italy, www.esaote.com) and evaluated by a dedicated software (OsiriX, 
www.osirix-viewer.com), is represented in mm and is considered an objective parameter.  
The secondary outcome, the recording of the subjective well-being of the test person, is determined 
using a visual analogue scale (VAS scale 0 - 10) and reflected in the number of cm. The value "0" 
describes "maximum feeling of well-being", the value "10" a "maximum feeling of discomfort". The value 
is considered a subjective parameter.  
  
9.1.2  Measurement of primary outcomes  
The ultrasound probe is used to record one reference point on the patella and one on the thigh (lateral 
epicondyle femoris) and store it as an image. After caudal mobilization, the same reference points are 
recorded and again stored as an image. This process is performed before the first and after each 
mobilization interval (1st-6th measurement). With the OsiriX software, the DICOM images obtained can 
be analyzed and evaluated. The distance of the displacement of the patella is shown in mm and 
transferred to the data sheet.  
9.1.3  Measurement of secondary outcomes  
Using a visual analogue scale, which goes from 0 – 10, subjective well-being is asked directly after the 
mobilisation intervals. The value "0" stands for "maximum well-being" and the value "10" for "maximum 
discomfort". The values are transferred to the data sheet.  

 
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9.1.4  
Collection of further results  
No further results will be collected.   
9.1.5  
Collection of safety parameters  
No safety parameters are collected except for the health questionnaire.  
9.1.5.1 Unfavorable Events   
-  
9.1.5.2 Laboratory Parameters  
-   
9.1.5.3 Vital signs  
-  
9.1.6  Collection of data in case of early termination of studies  
For the participants, there is no disadvantage in the event of an (arbitrary) discontinuation of study 
participation and no further interventions are necessary for follow-up treatment. The data collected to 
date will be evaluated as far as possible and included in the data analysis (in accordance with Art. 9 
ClinO).  
If study participation was discontinued due to an excessive reaction/injury occurring during study 
participation, this will be recorded and reported to the sponsor investigator (head of the research 
laboratory), who is also the study leader, and the supervisor of the study. In the event of necessary 
medical treatment, the report is sent to the business liability insurance of Thim van der Laan AG (Basler 
Versicherung).  
The following are recorded:  
- 
Date and time of the incident  
- 
Course of the incident  
- 
Persons involved & witnesses  
- 
Study ID (specified by the CEC)  
- 
Personal data of the person concerned (if not previously recorded)  
  
9.2  
Procedure at each visit of the test subjects  
9.2.1  
Subject recruitment – screening and randomization  
The study is being advertised internally at the University of Applied Sciences and Arts Southern 
Switzerland SUPSI. Interested parties should contact the director of studies at the research office of the 
University of Applied Sciences and Arts Southern Switzerland (SUPSI) for an initial consultation. 
Interested parties will be informed about the conditions of participation, the content and procedure of the 
study, as well as the amount of compensation. If you are still interested, the written study information and 
the confirmation of consent will be handed out. Interested parties can read the written documents at their 
leisure and ask any questions. If you agree to the terms of the study and wish to participate in the study, 
bring the signed documents to the principal investigator. A copy of the consent form signed by both 
parties will be given to the interested party. The health questionnaire is then filled out, which clarifies the 
suitability of the interested party to participate in the study. If the inclusion criteria are met, the interested 
party has passed the screening and is admitted to participate in the study. This is followed by the 
randomization of the application page by drawing lots and making an appointment for the 2 measurement 
days, in the same week with at least 2 days break between the measurements.  

 
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9.2.2  Preparation of test subjects   
The test subject wears shorts and is barefoot. He sits down on the treatment table. The backrest is raised 
so that an upright sitting position can be assumed. The leg of the application side is placed on the patello 
and fixed according to the product description (Chapter 8). The foot is placed underneath so that the leg 
can lie relaxed. In a first phase, the contact pressure of the device is adjusted based on the well-being 
of the test subject. The setting is noted.   
9.2.3 Sequence of the measurements   
After determining the contact pressure, the pre-mobilization measurement is carried out (1st 
measurement). The ultrasound probe is used to visualize a reference point on the patella and at the 
same time the lateral femoral epicondyle on the thigh and save it as an image. Afterwards, the 
mobilization pressure is built up individually up to the tolerance limit of the test subject so that a 
displacement of the patella caudally takes place. The maximum deflection of the patella to the reference 
point on the thigh is determined, the device settings are noted and transferred to the data sheet (2nd 
measurement).   
As described above, further measurements are carried out according to the following scheme: after 10 
mobilisations (3rd measurement), after 20 mobilisations (4th measurement), after 30 mobilisations 
(5th measurement) and after 50 mobilisations (6th measurement).  
  
Table 5: Overview of the course of studies  
Time  
Preparation  
Pre  
1 Mob.  
10 Mob.  
20 Mob.  
30 Mob.  
50 Mob.  
Time (min)  
  
5  
10  
20  
30  
40  
50  
Measurement  
  
1.  
2.  
3.  
4.  
5.  
6.  
Subject information  
X  
  
  
  
  
  
  
Consent  
X  
  
  
  
  
  
  
Demographics  
X  
  
  
  
  
  
  
Intervention   
  
  
X  
X  
X  
X  
X  
Ultrasound image  
  
X  
X  
X  
X  
X  
X  
Subj. Well-being   
  
X  
X  
X  
X  
X  
X  
  
9.2.4  
Multiple visits  
The procedure described above is carried out over 2 days. We know from practice that patients are 
usually treated by a physiotherapist 1-2 times a week. Thus, the subjects are measured 2x within the 
same week in order to be able to make a practical statement about possible lasting and/or cumulative 
effects.  
  
At the end of both measurement days, he/she will receive the amount due to him/her according to the 
advertisement.  
The lump sum is CHF 50.  
  

 
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9.3  
Drug study  
-  
9.3.1  
Definition and assessment of (serious) adverse events and other safety related events  
-  
9.3.2  
Reporting of serious adverse events (SAE) and other safety related events  
-  
9.3.3  
Follow up of (Serious) Adverse Events  
-  
9.4  
Medical Device Category C studies  
The Patello device is an innovative product that does not yet have CE certification. All individual 
components of the device are CE certified.  
In this experimental study for the effectiveness study, 30 test subjects are to be tested. The study focuses 
on basic findings. It serves as proof of effectiveness. The monitoring for quality assurance is carried out 
by Prof. Dr. Peter Clarys.   
  
9.4.1  
Definition and Assessment of (Serious) Adverse Events and other safety related events  
An adverse event (ADVERSE EVENT) AE) is any unfortunate medical occurrence in a study subject who 
is exposed to the intervention (as listed in Chapter 8.1.1) that is not necessarily causally related to the 
study process. An AE can therefore be any adverse and unintended sign, symptom, or temporal illness 
with the use of an intervention product (according to Chapter 8.1.1), either or in relation to the medical 
intervention product (according to Chapter 8.1.1).  
According to swissethics.ch, a serious adverse event (SAE) is classified as any unfortunate medical 
occurrence that results in death, is life-threatening, requires or prolongs hospitalization of the subject, 
results in a persistent or significant disability/inability, or is a congenital anomaly/birth defect. In our 
study, an SAE is not to be expected.   
If the intervention leads to a side effect, this is classified as a safety-relevant event by the study leader. 
For the affected study participant, the study is completed at this time, and the data already collected 
will be processed as described in chapters 7.4 and 9.1.6.  
On the last page of the subject-specific demographic data collection sheet, the following are recorded:   
- 
Date and time of the incident  
- 
Course of the incident  
- 
Persons involved & witnesses  
- 
Study ID (specified by the CEC)  
- 
Personal data of the person concerned (if not previously recorded)  
9.4.2  
Reporting of (Serious) Adverse Events and other safety related events  
In accordance with Art. 37, Art. 42, Art. 43  
9.4.3  
Follow up of (Serious) Adverse Events  
A safety-related event is logged and immediately reported to the sponsor investigator (head of the 
research laboratory), who is also the study leader, and the supervisor of the study.  

 
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The CEC will be informed as soon as possible and appropriate changes will be made to the protocol of 
the study. Further explanations can be found in chapter 2.10. Safety and protective measures must be 
reported to the responsible CEC within two days.  
The report continues to the business liability insurance (Basler Versicherung) of Thim van der Laan AG 
in Landquart.  
9.5  
Medical Device Category A studies  
-  
9.5.1  
Definition and recording of safety-relevant events  
-  
9.5.2  
Reporting of Safety related events  
-  
9.5.3  
Notification of a security-relevant event  
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10 STATISTICAL METHODS  
 
10.1 Hypotheses & Factors  
Mobilization of the patella in the caudal / cranial direction by the patello – repetitive mobilizations versus 
one-time mobilization Objective displacement of the patella:  
H0 The patella does not shift significantly more during repetitive mobilizations than during a 
single mobilization by the patello.  
H1 The patella shifts significantly more during repetitive mobilizations than during a single 
mobilization by the patello.  
  
Subjective well-being of the subject:  
H0 Subjective well-being does not change significantly more with repetitive mobilizations than 
with a single mobilization by the patello.  
H1 Subjective well-being changes significantly more with repetitive mobilizations than with a 
single mobilization by the patello.  
  
A 2-factor analysis is carried out.  
Factor 1:  
Intervention   
Factor 2:  
Time intervention: Start (pre-intervention, 1st measurement), after a single mobilization 
(2nd measurement), after 10 (3rd measurement), after 20 (4th measurement), after 30 
(5th measurement), after  
50 mobilizations (6th measurement)  
Sample size  
The planned sample size is n = 30 subjects. This size is expedient, time-wise and financially feasible for 
the study.  
  
10.2 Criteria for the statistical use of data in the case of incomplete data sets  
A complete mobilization interval must be completed for the data to be included in the study. If a 
mobilisation interval (e.g. interval '20 mobilisations', but termination after 15 mobilisations) has to be 
interrupted, only the previously collected complete mobilisation interval data can be used. This ensures 
that all data remains homogeneous and comparable. No substitute is sought for the missing mobilization 
interval data.  
  
10.3 Planned analyses   
10.3.1 Datasets and Data Population  
Only complete mobilization interval datasets will be included in the study and integrated into the analysis. 
No new test subject is being sought to replace the missing data.   

 
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10.3.2 Primary Analysis  
The statistical data analysis is carried out by the statistician after completion of the data collection of the 
entire project.  
  
Repeated measures analysis of variance (MANOVA) A 2-
factor analysis is performed.  
Factor 1:  
Intervention   
Factor 2:  
Time intervention: Start (pre-intervention, 1st measurement), after a single mobilization 
(2nd measurement), after 10 (3rd measurement), after 20 (4th measurement), after 30 
(5th measurement), after 50 mobilizations (6th measurement)  
  
  
  
  
The significance level is set at P < 0.05, and the statistical data analysis is carried out with SPSS V. 24.  
10.3.3 Secondary Analysis Not 
Available.  
10.3.4 Interim analyses  
The data is processed after the project ends. No additional interim analyses are planned.  
10.3.5 Security Analyses  
No security analyses are provided.  
10.3.6 Discrepancies  
Deviations from the planned statistical analysis are recorded and justified and reported to the CEC in the 
annual report.  
  
10.4 Drop-outs and Missing Data   
If a subject wishes to withdraw from the study before the end of all measurement days and interventions, 
or if he or she has to be excluded by the study leader due to an event, the complete mobilization interval 
data collected up to that point will be included in the data analysis.   
No replacement of test persons is being sought for the missing data sets.  
  
11 QUALITY ASSURANCE AND CONTROL  
 
11.1 Data Archiving  
11.1.1 Forms  
Data protection and confidentiality are guaranteed and no personal data is presented or published. The 
signed declaration of consent, as well as the completed questionnaire with the other personal data and 
demographic and medical personal data are stored in the original as a study document in a locked filing 
cabinet. Only the head of the study (head of the research laboratory of the University of Applied Sciences 
and Arts Southern Switzerland SUPSI, Physiotherapy Graubünden) has access (key possession) to this 

 
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cabinet. The encryption of the identity of the test persons is not digitally recorded, i.e. surname, first 
name and date of birth are not digitally recorded in any way.   
Direct access to the personal data will continue to be allowed only to authorized persons of the CEC.  
11.1.2 Specification of Forms  
The data collected in writing is recorded in the form listed in the enclosures and is marked as study 
data. They are therefore subject to data protection and are stored in accordance with the information 
described in chapter 12.1.1.  
11.1.3 Archiving the Data  
The data collected will be kept for 10 years. Data protection will continue to be guaranteed.  
  
11.2 Data Management   
11.2.1 Data Management System   
The raw data of the ultrasound are processed with the OsiriX software and the results are transferred to 
the data sheet of the test subject (number of mm displacement of the patella). The subjective perceptual 
parameters are asked orally and the answers are handwritten on the data sheet. For further data 
analysis, Microsoft Excel is used by Windowsâ. Microsoft Excel from Windows is also used for data 
pooling and for the graphical representation of the end data.  
11.2.2 Data Security and Backup  
The digital data is encrypted and treated confidentially, access to the personal data is not allowed to third 
parties. The digital data collected is stored solely on the institute's own computers and is not passed on 
to any external persons or transferred to other computers. Access to the computers of the research 
laboratory is only granted to the principal investigator and the investigators (listed in Chapter 1), as well 
as persons authorized by the CEC.  
11.2.3 Analysis and Archiving  
After collection, the digital data is encrypted and stored on another external hard drive for further backup. 
This is stored in a locked filing cabinet to ensure data protection.  
   
11.2.4 Validation of electronic data   
Immediately after data collection, the quality of the data is checked and verified with the help of the visual 
representation.   
  
11.3 Monitoring   
The data collected can be viewed by authorised persons at any time (see Chapter 12.2.2)  
The study is to be monitored by the following person:  
Prof. Dr. Peter Clarys  
Vrije Universiteit Brussels   
Faculty of Physical Education and Physiotherapy 
Pleinlaan 2, 1050 Brussels peter.clarys@vub.ac.be  
  

 
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11.4 Audits and inspections   
A report on the current status of the study is given orally to the study supervisor (Prof. Dr. Peter Clarys) 
on a monthly basis. This also includes demonstrating and presenting results and statistical analyses.   
An annual report on the course of the study will be submitted to the CEC. Authorized persons of the CEC 
can view the data forms as well as the digital data on the institute's own computers at any time.  
Data protection is guaranteed at all times.  
  
11.5 Confidentiality and data protection  
The examiners ensure that the privacy of the participant is guaranteed. In particular, data protection and 
confidentiality are guaranteed and no personal data is presented or published. The signed declaration 
of consent, as well as the completed questionnaire with the other personal details, are kept in the original 
as a study document in a locked filing cabinet.  
The digital data is encrypted and treated confidentially, access to the personal data is not allowed to third 
parties. The digital data collected is stored solely on the institute's own computers and is not passed on 
to any external persons or transferred to other computers.  
Direct access to the personal data is only allowed to authorized persons of the CEC.  
  
11.6 Retention of biological material and health-related data  
-   
 
  
  
  
12 PUBLICATION AND DISCLOSURE OF DATA  
 
The examiners ensure that the privacy of the participant is maintained. In particular, the data protection 
and confidentiality of the data are guaranteed and no personal data is presented or published nor passed 
on to outsiders and unauthorized persons.  
  
  
  
  
  
 

 
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14 FUNDING AND SUPPORT  
 
 
14.1  
Financing  
The study is being conducted by the University of Applied Sciences and Arts Southern Switzerland 
SUPSI, Physiotherapy Graubünden with a  
CTI support contribution. The auditors are employed by this institute and are remunerated for their work 
on this study in accordance with their employment contracts. No further support is needed.  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

 
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15 INSURANCE  
 
There is a business liability insurance with Baloise Insurance for Thim van der Laan AG in Landquart.  

 
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16 REFERENCES   
 
1. Barrack RL, Bertot AJ, Wolfe MW, Waldman DA, Milicic M, Myers L. Resurfacing of the patella 
in total knee arthroplasty. A prospective, randomized, double-blind study. J Bone Joint Surg Am 
(1997) 79/8: 1121-1131.  
2. Campbell DG, Duncan WW, Ashworth M, Mintz A, Stirling J, Wakefield L, Stevenson TM. Patellar 
resurfacing in total knee replacement. J Bone Joint Surg Br (2006) 88-B/6: 734-739.  
3. Cook JL, Khan KM, Purdam C. Achilles tendinopathy. Manual therapy 7/3 (2002) 121-120.  
4. Faust I. Human xylosyltransferases - mediators of arthrofibrosis? New pathomechanistic insights 
into arthrofibrotic remodeling after knee replacement therapy. Sci. Rep. (2015) 5, 12537. DOI: 
10.1038/srep12537.  
5. Gelse K, Pöschl E, Aigner T. Collagens - structure, function, and biosynthesis. Adv Drug Del Rev 
55 (2003) 1531–1546.   
6. Ghandhi R, de Beer J, Leone J, Petruccelli D, Winemaker M, Adili A. Predictive risk factors for 
stiff knees in total knee arthroplasty. J Arthroplasty (2006) 21/1: 46-52.  
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