Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm and the JuggerLoc™ Soft Tissue Systems (Implants and Instrumentation) in the Shoulder - A Multicenter Retrospective Study
Conditions: Bankart Lesions, SLAP Lesion, Acromioclavicular; Dislocation, Capsular Shift/Capsulolabral Reconstruction, Deltoid Repair, Rotator Cuff Tear Repair, Biceps Tendon Disorder
Sponsor: Zimmer Biomet

 
 
 
 
ToggleLoc 2.9mm and the JuggerLoc  
Study Protocol number: MDRG2017-89MS-70SM 
                          
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Post-market Clinical Follow-up Study to Provide 
Safety, Performance and Clinical Benefits Data of the 
ToggleLoc™ 2.9mm and the JuggerLoc™ Soft Tissue 
Systems (Implants and Instrumentation) in the 
Shoulder 
A Multicenter Retrospective Study 
 
Protocol number: MDRG2017-89MS-70SM  
Protocol date: 22.December.2021 
NCT number: NCT05584553 
 
 
 
 
 
 

 
 
 
 
ToggleLoc 2.9mm and the JuggerLoc  
Study Protocol number: MDRG2017-89MS-70SM 
                          
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Table of Contents 
1 
STUDY SYNOPSIS ............................................................................................................................................. 3 
2 
ABBREVIATIONS .............................................................................................................................................. 5 
3 
STUDY RATIONALE AND OBJECTIVES ............................................................................................................... 6 
4 
INTRODUCTION AND PURPOSE ....................................................................................................................... 8 
5 
STUDY DEVICE INFORMATION ....................................................................................................................... 10 
5.1 
STUDY DEVICE .................................................................................................................................................. 10 
5.2 
INSTRUMENTATION ........................................................................................................................................... 13 
5.3 
COMPATIBILITY ................................................................................................................................................. 13 
5.4 
ACCOUNTABILITY OF DEVICES .............................................................................................................................. 13 
6 
STATISTICAL METHODS ................................................................................................................................. 14 
6.1 
SAMPLE SIZE CALCULATION ................................................................................................................................. 14 
6.2 
GENERAL STATISTICAL METHODS AND DATA ANALYSIS ............................................................................................. 15 
7 
REFERENCES .................................................................................................................................................. 16 
 
 
 

 
 
 
 
ToggleLoc 2.9mm and the JuggerLoc  
Study Protocol number: MDRG2017-89MS-70SM 
                          
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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1 Study Synopsis 
Title 
Post-market Clinical Follow-up Study to Provide Safety, 
Performance and Clinical Benefits Data of the ToggleLoc™ 
2.9mm and the JuggerLoc™ Soft Tissue Systems (Implants 
and Instrumentation) in the Shoulder - A Multicenter 
Retrospective Study 
Single Identification 
Number (Clinical 
Investigational only as per 
Art. 70 of EU MDR) 
 
N/A 
Protocol Number 
MDRG2017-89MS-70SM 
Study Sponsor Contact 
Information 
Zimmer GmbH 
Zählerweg 4 
6300 Zug, Switzerland 
+41 (0) 58 854 80 00  
 
Zimmer Biomet 
Clinical Affairs Department 
1800 W. Center St., Warsaw, IN 46580, USA 
Phone: (800) 613-6131, Fax: (574) 372-4710 
Authorized 
Representative Contact 
Information, if applicable 
(Clinical Investigation only 
as per Annex XV of EU 
MDR) 
N/A 
Monitoring Contact 
Information 
Zimmer GmbH 
Zählerweg 4 
6300 Zug, Switzerland 
+41 (0) 58 854 80 00  
 
Zimmer Biomet 
Clinical Affairs Department 
1800 W. Center St., Warsaw, IN 46580, USA 
Phone: (800) 613-6131, Fax: (574) 372-4710 
Investigational Site 
Information (Clinical 
Investigation as per 
The study will include up to four sites. Details regarding the 
sites involved will be maintained in the Sponsor’s Trial Master 
File. 

 
 
 
 
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Annex XV of EU MDR) 
External Organizations, if 
applicable 
N/A  
 
 
 

 
 
 
 
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2 Abbreviations 
The following abbreviations are used throughout this study protocol.    
ADE 
Adverse Device Effect 
AE 
Adverse Event 
Case ID 
Case Identification Number 
CE 
Conformité Européene (European Conformity) 
CI 
Confidence Interval 
CRF 
Case Report Form 
CTA 
Clinical Trial Agreement 
DD 
Device Deficiency 
DOH 
Declaration of Helsinki 
EC 
Ethics Committee 
e-CRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EU MDR 
European Regulation (EU) 2017/745 
FDA 
Food and Drug Administration 
FUP 
Follow-Up 
GDPR 
General Data Protection Regulation 
ICF 
Informed Consent Form 
IFU 
Instructions for Use 
ICH  
International Conference on Harmonisation (Harmonization) 
ID 
Identification 
IRB 
Institutional Review Board 
ISO 
International Standards Organization 
MDCG 
Medical Device Coordination Group 
N/A 
Not Applicable 
PMCF 
Post-Market Clinical Follow-Up 
PROMS 
Patient-Reported Outcome Measures 
SAE 
Serious Adverse Event 
SADE 
Serious Adverse Device Effect 
USADE 
Unanticipated Adverse Device Effect 
 

 
 
 
 
ToggleLoc 2.9mm and the JuggerLoc  
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3 Study Rationale and Objectives 
 
This post-market clinical follow-up (PMCF) study, entitled “Post-market Clinical Follow-up Study to 
Provide Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9 mm and the 
JuggerLoc™ Soft Tissue Systems (Implants and Instrumentation) in the Shoulder” (Protocol No. 
MDRG2017-89MS-70SM), is sponsored by Zimmer Biomet, with the study devices manufactured 
by Biomet Sports Medicine. The ToggleLoc™ 2.9 mm and the JuggerLoc™ Soft Tissue Systems 
are implants specifically designed for soft tissue-to-bone fixation in the shoulder. The purpose of 
this investigation is to systematically confirm the devices’ safety, performance, and clinical benefits. 
The primary objective of the study is to evaluate device performance by assessing soft tissue-to-
bone healing in the shoulder. Secondary objectives include the assessment of device safety and 
clinical benefits. Safety will be evaluated by capturing the incidence and frequency of complications 
and adverse events (AEs), with specification of their relationship to the device, instrumentation, or 
procedure. Clinical benefits will be assessed using validated patient-reported outcome measures 
(PROMs), the Oxford Shoulder Score (OSS) and the EuroQol EQ-5D, collected at the longest 
available follow-up of at least one year postoperatively. 
The study is designed as a global, multicenter, retrospective, consecutive series. A total of 206 
cases will be included: 103 patients operated with the ToggleLoc™ 2.9 mm device and 103 patients 
with the JuggerLoc™ system. Eligible participants are consecutive patients previously operated 
with one of the study devices, provided they meet the study’s inclusion and exclusion criteria. 
The inclusion criteria require that patients: 
• 
Have received the ToggleLoc™ 2.9 mm and/or the JuggerLoc™ device for shoulder soft 
tissue-to-bone fixation; 
• 
Are skeletally mature adults, aged 18 years or older; 
• 
Are capable of understanding the surgeon’s explanations, willing and able to comply with 
follow-up instructions, and have provided informed consent to participate. 
The exclusion criteria disqualify patients who: 
• 
Present with infection; 
• 
Have poor bone or soft tissue quality, or limited blood supply; 

 
 
 
 
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• 
Have mental or neurological conditions that prevent adherence to postoperative care 
instructions; 
• 
Demonstrate foreign body sensitivity, unless pre-implant testing was performed; 
• 
Are unwilling or unable to provide informed consent or comply with follow-up requirements; 
• 
Have any condition that, in the investigator’s judgment, poses undue risk or interferes with 
study participation; 
• 
Are considered vulnerable subjects, including prisoners, individuals unable to understand 
study participation, patients with substance abuse, or those expected to be non-compliant; 
• 
Have undergone off-label use of the device. 
Clinical data will be obtained retrospectively from hospital and clinic databases, including 
preoperative and intraoperative records. In addition, a final follow-up visit, conducted at least one 
year after the initial operation, will be performed either on-site to collect PROMs and confirm clinical 
outcomes. All protocol deviations and adverse events will be systematically recorded throughout 
the study. Data will be collected using both paper and electronic formats and subsequently 
analyzed by Zimmer Biomet or its designee. Results will be summarized and shared with 
participating investigators. 
The study duration is expected to be 18 months. The outcomes will be reported using statistical 
methods appropriate for retrospective case series, with particular focus on safety events, 
performance, and PROMs. 
This PMCF study adheres to the highest international standards, including ISO 14155:2020 (Good 
Clinical Practice for medical device trials), the Declaration of Helsinki, European Medical Device 
Regulation (EU) 2017/745, and MDCG 2020-10/1 safety reporting guidelines. Study funding is fully 
provided by Zimmer Biomet, covering clinical data collection, IRB/EC fees, and associated study 
expenses, as outlined in the executed Clinical Trial Agreement. 
 
 
 
 

 
 
 
 
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4 Introduction and Purpose 
 
The musculoskeletal system functions through the coordinated action of multiple tissue types. 
These include, among others, specialized organized connective tissues such as tendons, 
ligaments, capsule and fascia. These connective tissues are attached to bone through a 
specialized interface called an insertion site or enthesis [5] [6]. Entheses integrate tendon or 
ligament structures to bone and facilitate joint motion [6].  Because entheses link soft to hard 
tissue, they are regions of high-stress concentration. As a result, they are susceptible to 
chronic and acute injury [5] [7]. 
Complete or partial detachment of ligaments, tendons and/or other soft tissues from their 
associated bones are common orthopedic injuries. The number and incidence of these types 
of injuries have increased substantially during the last few decades, especially the number of 
sports related injuries [8] [9]. 
Rotator cuff disorders are the most common causes of shoulder pain or disability, but other 
soft tissue injuries can also occur, requiring surgical techniques such as Bankart lesion repairs 
S.L.A.P. lesion repair, acromio-clavicular repair, capsular shift/ capsulolabral reconstruction, 
deltoid repair, biceps tenodesis and pectoralis major repair. 
The rotator cuff consists of four muscles (supraspinatus, infraspinatus, teres minor, and 
subscapularis), with the supraspinatus most commonly injured [10]. The etiology of rotator cuff 
tears is multifactorial and likely a combination of micro/macro trauma and age-related 
degenerative changes [11]. Athletes engaged in sports that involve overhead motions such as 
throwing, tennis, or swimming are more susceptible to overuse injury. The prevalence of 
symptomatic rotator cuff tears increases with increasing age [10] [12]. Full-thickness rotator 
cuff tears are present in approximately 13% of individuals in their 50s and 50% of individuals 
in their 80s [13]. Surgical management of massive rotator cuff tears remains challenging, with 
failure rates ranging from 20% to 90% [14]. 
When partial detachment of soft tissue structures from bone occurs, the injury may heal itself 
with conservative measures. However, in the case of complete detachment or when the 
conservative treatment has failed, surgical repair is required for restoration of function. Optimal 
fixation devices should confer immediate stability, resist gap formation, promote biologic 
healing, and restore the anatomic footprint of the native tendon or ligament [15]. From an 
evolutionary point of view, there has been a lot of advancement in shoulder repair. In the last 
decades, rotator cuff surgery has developed from open surgery to an all-arthroscopic 
procedure. Arthroscopic repair of rotator cuff led to decreased immediate post-operative pain, 
decreased surgical insult to the deltoid and decreased post-operative stiffness [12] and is now 
an established method of treatment with reproducible results.  
Numerous devices are currently available to re-attach soft tissue to bone. Among others, 
suture anchors are one of the most important innovations in arthroscopic shoulder surgery for 
tendon or ligament fixation to bone [15].  
Many designs of suture anchors are available, with individual characteristics that influence the 
appropriateness of its usage including size, shape, composition, and holding strength. 

 
 
 
 
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The aim of this retrospective post-market clinical follow-up study is to confirm performance, 
clinical benefits and safety of the ToggleLoc 2.9mm and the JuggerLoc Soft Tissue Systems 
when used for soft tissue to bone fixation in the shoulder. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
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5 Study Device Information 
 
5.1 Study Device 
The ToggleLoc 2.9 mm and JuggerLoc Soft Tissue devices consist of non-resorbable devices 
intended to aid in arthroscopic and orthopaedic reconstructive procedures requiring soft tissue 
to bone fixation. The clinical purpose is to restore the function and flexibility of the specific 
anatomical area requiring soft tissue to bone fixation and to relieve pain that cannot be 
controlled by other treatments. These Systems have been in clinical use since 2015 and are 
currently CE marked. The ToggleLoc 2.9 mm and JuggerLoc Soft Tissue Systems are FDA 
cleared implants intended for soft tissue to bone fixation in the shoulder, knee, and elbow.  
The JuggerLoc has a low profile, all suture bone anchor made of woven Ultra-High Molecular 
Weight Polyethylene (UHMWPE) (Figure 1). It is connected to a Zip loop construct also made 
from UHMWPE, and may be constructed with or without additional suture strands with needles. 
The JuggerLoc can be anchored directly into the bone, allowing the soft tissue to be attached 
directly into the bone without the need for a complete end-to-end bone channel. 
 

 
 
 
 
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Figure 1. JuggerLoc Soft Tissue Pull Through with (a) and without (b) Needles and 
JuggerLoc Unicortical Soft Tissue Fixation without Needles (c). 
 
The ToggleLoc 2.9 mm consists of a metallic anchor made of Ti6Al4V connected to a Zip loop 
construct of UHMWPE. Two configurations to attach soft tissue exist, one with and one without 
needles (Figure 2). To implant the ToggleLoc 2.9 mm, a hole is drilled through the bone to 
create a bone channel. The anchor resides on the bone surface, and the suture extends 
through the bone and around/through the soft tissue, where is it tied (Figure 3). 
 
 
 
 

 
 
 
 
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Figure 2. ToggleLoc 2.9 mm Soft Tissue System devices (with and without needles) 
with metallic hard bone anchor and the Zip loop technology. 
 
Figure 3. ToggleLoc 2.9 mm Soft Tissue Systems requires a bone channel for fixation 
of soft tissue to bone. 
 
The two systems and their attached sutures are long-term implants that directly contact bone, 
soft tissue, and body fluids. Whereas these devices are designed for permanent implantation, 
the necessary functional lifetime is until healing has occurred, as the intended purpose of these 
devices is to provide internal fixation while the body heals naturally, typically 6 weeks to 1 year. 
 
 
 

 
 
 
 
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5.2 Instrumentation 
The ToggleLoc 2.9 mm and JuggerLoc Soft Tissue devices are intended to be used only with 
the JuggerLoc Instruments. The use of instruments or implant components from other systems 
can result in inaccurate fit, incorrect sizing, excessive wear and device failure. Further 
information on the clinical use of the instruments is available in the relevant surgical technique. 
5.3 Compatibility 
To determine whether devices have been authorized for use in a proposed combination with 
Zimmer and/or Biomet products, please contact your sales representative or visit the Zimmer 
Electronic Labeling Service (eLabeling) website: https://labeling.zimmerbiomet.com/  
5.4 Accountability of Devices 
Device accountability is not required for this study. The devices used in the study are 
commercially available via FDA 510(k) # K141263 and CE O2271.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
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6 Statistical Methods 
 
6.1 Sample Size Calculation 
The overall success rate will be calculated based on the percentage of subjects who have had 
successful soft tissue to bone healing in the shoulder. The following hypotheses will be tested 
by exact binomial test:  
H0: E1 – E0 ≤ - δE 
Ha: E1 – E0 > - δE 
Where:  
E0 = 85 % the expected success rate of similar devices when used in the shoulder 
E1 = the success rate in the ToggleLoc 2.9 mm Soft Tissue System treatment group in the 
shoulder 
δE = 0.10, non-inferiority margin for soft tissue to bone healing in the shoulder 
and 
H0: E1 – E0 ≤ - δE 
Ha: E1 – E0 > - δE 
Where:  
E0 = 85 % the expected success rate of similar devices when used in the shoulder 
E1 = the success rate in the JuggerLoc Soft Tissue System treatment group in the shoulder 
δE = 0.10, non-inferiority margin for soft tissue to bone healing in the shoulder 
In addition, one-sided 95% exact confidence Interval (CI), lower limit of the success rate, will 
be calculated. 
Based on the hypothesis test above, 103 subjects operated with the ToggleLoc 2.9 mm and 
103 subjects operated with the JuggerLoc Soft Tissue Systems in the shoulder will provide 
approximately 80% power for the one-sided exact binomial test at 0.05 significant level. The 
sample sizes were calculated using SAS version 9.4. 
 
 
 
 
 
 

 
 
 
 
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6.2 General Statistical Methods and Data Analysis  
Data collected in the study will be summarized descriptively. Descriptive summaries will be 
the basis of study reports to participants, as well as to generate an overall summary of the of 
the clinical evaluation of the ToggleLoc 2.9 mm and the JuggerLoc Soft Tissue Systems and 
their instrumentation when used in the shoulder.  
Continuous data (e.g. age) will be summarized through means, medians, standard deviation, 
minimum, maximum and 95% confidence intervals (CIs) over time periods of interest. 
Categorical data (e.g. gender) will be summarized using counts, percentages and 95% 
confidence limits over time periods of interest. Summaries of complication data will be 
presented as frequencies and percentages. Subgroup summaries will be generated as 
needed either by strata within the study population (e.g. male vs. female, preop diagnosis) or 
by different cut-points (e.g. body mass index (BMI) ranges). Patient confidentiality will be 
protected at all times, and patient identifiers will not be included in data summaries. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
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7 References 
[1]  
Clinical Investigation of medical devices for human subjects - Good Clinical practice. 
ISO 14155:2020, 2020.  
[2]  
World Medical Association Declaration of Helsinki, Ethical Principles for Medical 
Research Involving Human Subjects. 59th WMA General Assembly, Seoul, 2008.  
[3] 
Regulation (EU) 2017/745 of the European Parliament and of the council of 5 April 
2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC No 
178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 
90/385/EEC and 93/42/EEC 
[4] 
MDCG 2020-10/1, accessed 29 September 2021, 
<https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2020-10-
1_guidance_safety_reporting_en.pdf> 
[5]  
Benjamin M, Toumi H, Ralphs JR, Bydder G, Best TM, Milz S. Where tendons and 
ligaments meet bone: attachment sites ('entheses') in relation to exercise and/or 
mechanical load. Journal of anatomy, 2006;208(4):471-90.  
[6]  
Lu HH, Thomopoulos S. Functional attachment of soft tissues to bone: development, 
healing, and tissue engineering. Annual review of biomedical engineering. 
2013;15:201-26.  
[7]  
Apostolakos J, Durant TJ, Dwyer CR, Russell RP, Weinreb JH, Alaee F, et al. The 
enthesis: a review of the tendon-to-bone insertion.," Muscles, ligaments and tendons 
journal. 2014;4(3):333-42.  
[8]  
Kaux JF, Forthomme B, Goff CL, Crielaard JM, Croisier JL. Current opinions on 
tendinopathy. Journal of sports science & medicine. 2011;10(2):238-53.  
[9]  
Jarvinen TA, Kannus P, Maffulli N, Khan KM. Achilles tendon disorders: etiology and 
epidemiology. Foot and ankle clinics. 2005;10(2):255-66.  
[10] 
Scott A, Ashe M. Common tendinopathies in the upper and lower extremities. Current 
sports medicine reports, 2006;(5)233-41.  
[11] 
Longo UG, Franceschi F, Ruzzini L, Rabitti C, Morini S, Maffulli N, Denaro V. 
Histopathology of the supraspinatus tendon in rotator cuff tears. Am J Sports Med. 
2008;36(3):533-8.  
[12] 
Kumar R, Jadhav U. Functional evaluation of patient after arthroscopic repair of 
rotator cuff tear. Journal of Clinical Orthopaedics and Trauma. 2014;5(2):84-90.  
[13] 
Tempelhof S, Rupp S, Seil R. Age-related prevalence of rotator cuff tears in 
asymptomatic shoulders. J Shoulder Elbow Surg. 1999;8(4):296-9.  
[14] 
Chalmers PN, Frank RM, Gupta AK, Yanke AB, Trenhaile SW, Romeo AA, Bach Jr 

 
 
 
 
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BR, Nikhil NV. Allarthroscopic patch augmentation of a massive rotator cuff tear: 
surgical technique. Arthrosc Tech, 2013;2(4): e447-51.  
[15] 
Cole BJ, Sayegh ET, Yanke AB, Chalmers PN, Frank RM. Fixation of Soft Tissue to 
Bone: Techniques and Fundamentals. The Journal of the American Academy of 
Orthopaedic Surgeons. 2016; 24(2):83-95, 2016.