Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the ToggleLoc™ 2.9mm Soft Tissue System (Implants and Instrumentation) in the Elbow - A Multicenter Retrospective Consecutive Study
Conditions: Epicondylitis of the Elbow, Biceps Tendon Disorder
Sponsor: Zimmer Biomet

Post-market Clinical Follow-up Study to Provide 
Safety, Performance and Clinical Benefits Data of 
the ToggleLoc™ 2.9mm Soft Tissue System 
(Implants and Instrumentation) in the Elbow 
A Multicenter Retrospective Consecutive Study 
MDRG2017-89MS-72SM 
V 1.2 
20.SEP.2022
GLOBAL
NCT05519228 
STUDY SPONSORS 
Zimmer GmbH 
Zimmer Biomet 
Zählerweg 4 
Clinical Affairs Department 
6300 Zug, Switzerland 
1800 West Center Street 
+41 (0)58 854 80 00
Warsaw, IN 46580 
800-613-6131

Complete Protocol Title 
Post-market Clinical Follow-up Study to Provide Safety, 
Performance and Clinical Beneﬁts Data of the 
ToggleLoc™ 2.9mm Soft Tissue System (Implants and 
Instrumentation) in the Elbow - A Multicenter 
Retrospective Consecutive Study 
Protocol Number 
MDRG2017-89MS-72SM 
Short Protocol Title 
ToggleLoc 2.9 Elbow Study 
Sponsor 
Zimmer Biomet 
Manufacturer 
Biomet Sports Medicine 
Study Device(s) 
ToggleLoc 2.9mm Soft Tissue System (Implants and 
Instrumentation) 
Technical Documentation 
Reference Number 
EU7010.IIb 
Study Objectives/Endpoints 
The objective of this post-market clinical follow-up 
study is to collect data conﬁrming safety, performance 
and clinical beneﬁts of the ToggleLoc 2.9mm Soft Tissue 
System when used for soft tissue to bone ﬁxation in the 
elbow. 
The primary objective is the assessment of performance 
by analyzing soft tissue to bone healing in the elbow. 
The secondary objective is the assessment of safety 
and clinical beneﬁts. Safety will be evaluated by 
recording and analyzing the incidence and frequency of 
complications and adverse events. Relation of the 
events to device, instrumentation and/or procedure will 
be speciﬁed. Clinical beneﬁts will be assessed by 
recording patient-reported outcome measures (PROMs) 
at the longest follow-up after surgery (minimum one 
year). 
Indications/Target Population 
Consecutive series of patients who have been operated 
with the ToggleLoc 2.9mm Soft Tissue System in the 
elbow and who meet the inclusion criteria and none of 
the exclusion criteria. Inclusion/exclusion criteria are 
based on the indications and contraindications in the 
Instruction for Use (IFU). 
Inclusion/Exclusion Criteria 
Inclusion Criteria 
- 
Patients who received the ToggleLoc 2.9 mm 
Soft Tissue device for soft tissue to bone ﬁxation 
in the elbow. 
- 
Patients 18 years or older and skeletally mature. 

- 
Patients capable of understanding the surgeon’s 
explanations and following his/her instructions, 
able and willing to participate in the follow-up 
program and who gave consent to take part in 
the study. 
Exclusion Criteria 
- 
Infection. 
- 
Patient conditions including blood supply 
limitations, and insufficient quantity or quality of 
bone or soft tissue. 
- 
Patients with mental or neurologic conditions 
who are unwilling or incapable of following 
postoperative care instructions. 
- 
Foreign body sensitivity. Where material 
sensitivity is suspected, testing is to be 
completed prior to implantation of the device. 
- 
Patients who have any condition that would in 
the judgment of the Investigator place the 
patient at undue risk or interfere with the study.  
- 
Patient is a vulnerable subject (prisoner, 
mentally incompetent or unable to understand 
what participation to the study entails, a known 
alcohol or drug abuser, anticipated to be non-
compliant). 
- 
Off-label use. 
Study Design 
Global, Multicenter, Retrospective, Consecutive series  
Clinical Phase 
Post-market 
Sample Size  
83 cases implanted with the study device in the elbow. 
Length of Study 
18 months  
Materials and Methods 
Clinical records of these patients will be obtained from 
the clinic database, including pre-operative and 
intraoperative information. A ﬁnal follow-up (FUP) visit 
(minimum 1-year post-operation) will be conducted by 
phone or on site. Protocol deviations and adverse 
events will be captured throughout the study. 
Data Collection 
Paper/Electronic 
Statistical Reporting 
Data collected will be summarized and reported to each 
participating investigator. Statistical analysis will be 
conducted by Zimmer Biomet or its designee.  

 
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 clinical evaluation of the 
ToggleLoc 2.9mm Soft Tissue System and its 
instrumentation when used in the elbow. 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. 
Scores/Performance Assessments 
EuroQol (EQ-5D), Oxford Elbow Score, Adverse Events. 
Standards 
The PMCF is compliant with the below: 
• 
ISO 14155: 2020 - Clinical investigation of 
medical devices for human subjects - Good 
clinical practice [1]. 
• 
The Declaration of Helsinki (DoH) - Ethical 
principles for medical research involving human 
subjects [2]. 
• 
European Regulation (EU) 2017/745 [3] 
• 
MDCG 2020-10/1 Safety reporting in clinical 
investigations for medical devices under the 
Regulation (EU) 2017/74 [4] 
Study Funding 
Funding for this clinical study is made available by 
Zimmer Biomet to support clinical data collection, 
IRB/EC review fees and other expenses associated with 
the conduct and execution of this study protocol as 
outlined in the fully executed Clinical Trial Agreement.