Descriptive Single-center Retrospective Study of a Series of Cases of Clavicle Pseudarthrosis: Epidemiology, Surgical Management, and Functional Outcomes
Conditions: Pseudarthrosis, Clavicle Fracture, Clavicle Fracture, Non Union/Malunion
Sponsor: University Hospital, Brest

Single-center retrospective descriptive case series study of clavicle nonunion: epidemiology, 
surgical management, and functional outcomes | NCT__________ (if available) | Document 
date: 15 January 2026 | Version 1 
 
COVER PAGE 
SCIENTIFIC PROTOCOL (SINGLE-CENTER) 
Study document for ClinicalTrials.gov submission 
 
Official Title 
Single-center retrospective descriptive case 
series study of clavicle nonunion: 
epidemiology, surgical management, and 
functional outcomes 
ClinicalTrials.gov Identifier 
NCT__________ (if available) 
Document date 
15 January 2026 
Protocol version 
1 
Registration reference (internal) 
ENR 
Data Controller / Sponsor 
CHU de Brest, 2 avenue Foch, 29609 Brest 
Cedex, France 
Document type 
Scientific protocol (retrospective 
observational study) 
 
This document includes identifying information on the cover page and in the header of each 
page (Official Title, NCT number if available, and document date), in accordance with 
ClinicalTrials.gov Results Data Element Definitions. 
 
 

Single-center retrospective descriptive case series study of clavicle nonunion: epidemiology, 
surgical management, and functional outcomes | NCT__________ (if available) | Document 
date: 15 January 2026 | Version 1 
 
Single-center retrospective descriptive case series study of 
clavicle nonunion: epidemiology, surgical management, and 
functional outcomes 
Scientific Protocol Summary 
 
Study identifiers 
Study reference 
To be completed by the DRCI 
Acronym 
To be completed 
Protocol version 
1 
Project team 
Data Controller 
CHU de Brest, 2 avenue Foch, 29609 Brest 
Cedex, France 
Principal Investigator / Study Coordinator 
Dr Agathe YVINOU, CCA-AHU; 
agathe.yvinou@gmail.com / 
agathe.yvinou@chu-brest.fr; Department of 
Orthopaedic and Trauma Surgery, CHU de 
Brest (Cavale Blanche site), Boulevard Tanguy 
Prigent, 29200 Brest, France 
Resident (if applicable) 
Anaelle KOPP 
Department 
Department of Orthopaedic and Trauma 
Surgery 
Scientific Committee (if applicable) 
To be completed by the DRCI 
Ethics Committee (if applicable) 
To be completed by the DRCI 
Biostatistician 
Dr Hoel LETISSIER; hoel.letissier@chu-
brest.fr; Department of Orthopaedic and 
Trauma Surgery, CHU de Brest (Cavale 
Blanche site), Boulevard Tanguy Prigent, 
29200 Brest, France 
Methodologist 
Title / Surname / First name / email / 
professional address (to be completed) 
Funding 
No funding 
DPO contact 
protection.donnees@chu-brest.fr 
Legal framework 
Project compliant with Reference 
Methodology MR-004. Declaration date: 20 
August 2018. Declaration No.: 2205306 v0. 

Single-center retrospective descriptive case series study of clavicle nonunion: epidemiology, 
surgical management, and functional outcomes | NCT__________ (if available) | Document 
date: 15 January 2026 | Version 1 
 
Objectives and purpose 
Background, objectives, and rationale 
This single-center retrospective observational study describes a case series of clavicle nonunions 
treated surgically at CHU de Brest. Clavicle nonunion is a rare complication associated with pain, 
functional limitation, and reduced quality of life. Surgical management most often involves plate 
fixation, with generally favorable union rates; however, no clear superiority has been shown for 
a specific plate type or graft strategy in the literature (Wiss 2021; Hollo 2020; Song 2021; 
Muhlenfeld 2024). 
The project relies exclusively on data generated during routine care (medical records and 
imaging), without additional visits or interventions. Given the low local incidence, an exhaustive 
description of operated cases is required to characterize patient profiles, management, and 
outcomes. 
Remaining uncertainties include (i) whether bone grafting is systematically necessary, (ii) the 
impact of clavicular length restoration, (iii) predictors of nonunion repair failure, and (iv) the 
magnitude and variability of functional improvement. Recent studies suggest that 3.5 mm 
locking plates may be sufficient in most nonunions, and that functional outcomes improve 
significantly, albeit with inter-patient variability. Recent cohorts have also identified risk factors 
for failure (age, BMI, smoking, chronicity of nonunion). 
Vascularized bone reconstruction may be considered salvage therapy for recalcitrant nonunions 
or segmental defects, with high union rates but increased donor-site morbidity depending on 
the flap. Other salvage options have also been described (e.g., the Masquelet technique). 
Study purposes: 
• 
Improve patient management: refine indications (plate alone vs plate + graft), follow-up 
scheduling, and prevention of reoperations. 
• 
Evaluate local practice: document complications, reinterventions, and real-world functional 
outcomes at the center. 
• 
Surveillance: monitor infections, implant failures, and persistent nonunions. 
 
Primary objective 
Primary endpoint 
Describe clinical, radiological, and therapeutic 
characteristics of clavicle nonunions treated 
surgically in our center, and estimate the 
union rate after surgery. 
Union rate at 6 months (assessment window 
4-8 months), defined clinically and 
radiographically; complementary analysis: 
time to union (weeks). 
Secondary objectives 
Secondary endpoints 
Functional outcomes at last follow-up. 
Constant and/or DASH scores; pre/post 
change if available; proportion of clinical 

Single-center retrospective descriptive case series study of clavicle nonunion: epidemiology, 
surgical management, and functional outcomes | NCT__________ (if available) | Document 
date: 15 January 2026 | Version 1 
 
success. 
Complications and reinterventions. 
Infection, implant failure, persistent pain, 
revision; time to reintervention. 
Factors associated with failure of union. 
Age, sex, smoking, time from fracture to 
surgery, plate type, graft (yes/no), graft type, 
comorbidities, radiographic morphology. 
Factors associated with poor functional 
outcome. 
Same variables as above (exploratory). 
Comparison of technical strategies. 
Plate alone vs plate + graft; graft type; non-
vascularized vs vascularized graft in 
recalcitrant cases - compare union, time to 
union, functional scores, complications, 
reinterventions. 
Recovery trajectories. 
Pain (VAS), range of motion 
(elevation/abduction), return to 
activities/work (weeks). 
Ethical considerations 
The project raises no specific ethical concerns. It does not undermine participants’ dignity, does 
not stigmatize any specific group, and follows applicable professional and ethical rules. 
Participation is based on the absence of objection (opt-out) after clear and complete 
information has been provided. Confidentiality and anonymity are ensured throughout the 
study. 
Public interest justification 
The project pursues a public interest by clearly stating its purposes and expected benefits for 
patients, the healthcare system, and the scientific community. 
Purposes: 
• 
Improve quality of care: standardize description of surgically treated clavicle nonunion 
patients, techniques used (type of fixation, bone grafting), and outcomes (union, 
complications, functional scores) to optimize indications and post-operative follow-up. 
• 
Evaluate professional practices: measure real-world performance (union rate/time to union, 
reinterventions, morbidity) and identify opportunities for improvement (protocols, implant 
choices, rehabilitation schedule). 
• 
Generate useful and reproducible knowledge: produce real-world data on a rare and 
heterogeneous condition with limited robust evidence to inform local recommendations 
and future literature syntheses. 
• 
Contribute to care planning and appropriateness: estimate organizational impact (pathway, 
consultations, imaging, reoperations) to guide resources toward the most effective and 
efficient strategies. 
Benefits: 

Single-center retrospective descriptive case series study of clavicle nonunion: epidemiology, 
surgical management, and functional outcomes | NCT__________ (if available) | Document 
date: 15 January 2026 | Version 1 
 
• 
Benefits for patients (direct / short-term) 
• 
Better selection of indications (plate alone vs graft), limiting reoperations and 
complications. 
• 
Standardized follow-up (assessment windows, union criteria), promoting faster return to 
activities and work. 
• 
Reduced unnecessary exposure (non-relevant visits/exams) through harmonization of 
practices. 
• 
Benefits for society and the healthcare system (indirect / medium-term) 
• 
Reduced avoidable costs related to revision surgery, prolonged sick leave, and 
complications. 
• 
Improved equity of access to evidence-informed management, including for complex or 
delayed cases. 
• 
Strengthened quality and safety of care via outcome indicators monitored over time 
(union, complications, satisfaction). 
• 
Benefits for the scientific community (indirect / short- and long-term) 
• 
Exhaustive single-center data useful for meta-analyses and inter-center comparisons on 
homogeneous criteria (Constant, DASH, union rate/time to union). 
• 
Hypothesis generation for future trials (role of grafting, implant type, predictors of 
failure) and translational research (biology of nonunion). 
Results dissemination and valorization 
Any results disseminated outside the project team will be anonymized and will not allow direct 
or indirect identification of patients or healthcare professionals. CHU de Brest owns the data; no 
use or transfer to a third party may occur without prior agreement. The authors’ affiliation must 
include 'CHU de Brest'. 
Work derived from this protocol will be communicated and/or published under the 
responsibility of the study lead and/or supervisor. Co-authors will include investigators involved 
in the study in proportion to their contribution, together with the biostatistician. A copy of 
publications will be sent to the Delegation for Clinical Research and Innovation (DRCI). 
Publication rules will follow international recommendations (N Engl J Med. 1997;336:309-315). 
The study may be registered by the project investigator on an open-access registry before the 
first patient is included, if required by journals. 
Planned publication: Orthopaedics & Traumatology: Surgery & Research (OTSR, category C). 
Planned oral communications: SOO 2026; SOFCOT 2026. 

Single-center retrospective descriptive case series study of clavicle nonunion: epidemiology, 
surgical management, and functional outcomes | NCT__________ (if available) | Document 
date: 15 January 2026 | Version 1 
 
Methodology 
Study design 
Single-center cohort study reusing data generated during routine care. 
Participant inclusion is retrospective. 
Study population: description and justification 
Period of interest 
Patients managed between 1 January 2000 and 31 December 2024. 
Inclusion criteria 
Eligible cases (per clavicle) must meet all of the following: 
• 
Period and center: patients managed at CHU de Brest (Orthopaedics-Traumatology 
Department) and operated for clavicle nonunion between 01/01/2000 and 31/12/2024 (to 
ensure at least 1 year of follow-up at the time of analysis). 
• 
Age: 18 years or older at the time of the index surgery. 
• 
Diagnosis: clavicle nonunion defined as absence of clinical and radiographic union at least 6 
months after the initial fracture, or radiographic signs of nonunion (gap, absence of bridging 
callus, sclerotic bone ends) with compatible symptoms, documented in the record. 
• 
Index treatment: surgical management of the nonunion (plate fixation with/without graft, 
vascularized graft, or another reconstructive technique). 
• 
Minimal available data: pre-operative and/or intra-operative imaging confirming nonunion, 
and at least one post-operative clinical and/or radiographic assessment (regardless of exact 
timing). 
• 
Scope: aseptic and/or septic nonunions. 
Non-inclusion criteria 
Cases will not be included if any of the following apply: 
• 
Age under 18 years. 
• 
Non-surgical management only (conservative treatment). 
• 
Acute clavicle fractures (time since fracture under 6 months without nonunion criteria) or 
delayed union without nonunion criteria. 
• 
Pathological fractures due to tumor or metastasis; congenital clavicle nonunion. 
• 
Management outside the study period or outside CHU de Brest. 
• 
Objection to data processing / lack of legal basis (if applicable under local GDPR framework). 
• 
Adults under legal protection (guardianship/curatorship) if applicable. 
Exclusion criteria (after initial screening): 

Single-center retrospective descriptive case series study of clavicle nonunion: epidemiology, 
surgical management, and functional outcomes | NCT__________ (if available) | Document 
date: 15 January 2026 | Version 1 
 
• 
Insufficient documentation to assess exposure and/or primary outcome: no usable pre- or 
post-operative imaging and no post-operative follow-up available (immediate loss to follow-
up). 
• 
Early death unrelated to the condition or surgery before any post-operative assessment. 
• 
Active infection not documented: suspected sepsis at the site without microbiological 
confirmation and without a clear therapeutic strategy preventing septic/aseptic 
classification. 
• 
Major concomitant ipsilateral trauma (e.g., severe brachial plexus injury, major 
scapulothoracic stiffness, recent glenohumeral arthroplasty) making functional scores 
uninterpretable. 
• 
Unresolved inconsistent identifiers/duplicates (same patient - same clavicle). 
Sample size 
As this is a single-center retrospective descriptive case series over 24 years, the expected 
number of patients is estimated to be at most 30 at CHU de Brest. The condition is rare. 
Data sources 
Data originate exclusively from routine care and are available in medical records and imaging 
archives. 
Variables 
Only data strictly necessary to conduct the research will be collected. 
Identifying data: Yes - age and sex. 
Health data: Yes - weight, height, treatments related to the study and concomitant treatments, 
examination results, results from biological samples (if any), medical imaging (MRI, CT, 
ultrasound, X-ray), adverse effects and adverse events, personal/family history, comorbidities or 
associated events, and data related to a health status likely to influence results. 
Patient data: 
• 
Major comorbidities: diabetes, vascular disease, renal failure, osteoporosis, inflammatory 
diseases, immunosuppression. 
• 
Treatments influencing union: chronic corticosteroids, bisphosphonates, anti-TNF, etc. 
• 
Pre-operative ASA score (I-IV). 
Initial fracture data: 
• 
Mechanism (fall from standing height / sport / road traffic accident / high-energy / 
iatrogenic). 
• 
Side (if not already recorded) and dominant hand. 
• 
Initial fracture management (non-operative / operative; if operative: type of fixation). 

Single-center retrospective descriptive case series study of clavicle nonunion: epidemiology, 
surgical management, and functional outcomes | NCT__________ (if available) | Document 
date: 15 January 2026 | Version 1 
 
• 
Complications of initial management (infection, implant breakage, secondary displacement). 
• 
Number of previous interventions on the same clavicle (0, 1, >=2). 
• 
Date of initial fracture. 
• 
Date of first surgery. 
• 
Date of nonunion diagnosis. 
• 
Date of index nonunion surgery. 
Nonunion characteristics (pre-operative): 
• 
Time from fracture to nonunion surgery (weeks). 
• 
Nonunion type (hypertrophic / atrophic / oligotrophic). 
• 
Bone loss / diastasis (mm). 
• 
Bone-end quality (sclerosis, osteolysis). 
• 
Pain (VAS 0-10 at rest and during activity). 
• 
Pre-operative function (Constant, DASH if available). 
• 
Glenohumeral range of motion (forward elevation degrees, abduction degrees, external 
rotation, internal rotation). 
Infection status (if suspected/history): 
• 
Clinical signs (sinus tract, discharge, erythema, inflammatory pain). 
• 
Pre-operative CRP (mg/L) and ESR (mm/h). 
• 
MSIS pre-operative criteria. 
• 
Aspiration/samples (date, number of specimens). 
• 
Microbiology (organisms, susceptibility, colonization vs infection). 
• 
Classification (aseptic vs septic nonunion). 
Pre-operative imaging: 
• 
Standard radiographs (yes/no; date; views). 
• 
CT scan (yes/no; date; measured defect). 
• 
Other (MRI / bone scan). 
• 
Radiographic criteria of nonunion (absence of bridging, radiolucent line, diastasis). 
Operative details (index surgery): 
• 
Surgery date. 
• 
Type of anesthesia (general / regional / combined). 
• 
Approach (superior, anterior). 
• 
Debridement / freshening (yes/no; description). 
• 
Reduction / length restoration (yes/no; target mm). 
• 
Fixation type (3.5 mm locking plate / non-locking plate / other; manufacturer/implant). 
• 
Additional fixation (cortical/locking screws, cerclage/tension band, structural graft). 

Single-center retrospective descriptive case series study of clavicle nonunion: epidemiology, 
surgical management, and functional outcomes | NCT__________ (if available) | Document 
date: 15 January 2026 | Version 1 
 
• 
Bone graft (none / non-vascularized autograft / allograft / vascularized graft). 
• 
Harvest site (iliac cancellous/corticocancellous, fibula, other). 
• 
Graft volume/length (mL / mm). 
• 
Antibiotic prophylaxis (drug, dose, duration). 
• 
Intra-operative samples (number, sites). 
• 
Intra-operative complications (neurovascular injury, iatrogenic fracture, bleeding). 
• 
Operative time (minutes) / blood loss (mL). 
• 
Drain (yes/no; removal post-op day). 
Immediate post-operative course and rehabilitation protocol: 
• 
Immobilization (type, duration). 
• 
Load/constraint release schedule (week X). 
• 
Physiotherapy (start, goals, frequency). 
• 
Analgesics/antibiotics (drugs, durations). 
• 
Length of stay (days); discharge home/rehab facility. 
Clinical and radiological follow-up: 
• 
For each visit (e.g., 6 weeks, 3-4 months, 6 months, and last follow-up): 
• 
Pain (VAS/NRS). 
• 
Function (Constant and/or DASH; record score version). 
• 
Range of motion (elevation, abduction, external rotation, internal rotation). 
• 
Patient satisfaction (yes/no or 0-10 scale). 
• 
Return to activity/work (yes/no; time in weeks). 
• 
Imaging (radiographs yes/no; union criteria). 
• 
Clinical union (yes/no). 
• 
Radiographic union (yes/no). 
• 
Date of first documented union (YYYY-MM-DD). 
Endpoints: 
• 
Primary endpoint: union rate at 6 months (yes/no at month 6; window 4-8 months). 
• 
Time to union (days/weeks from index surgery to first evidence of union). 
• 
Secondary endpoints: Constant/DASH at last follow-up; complications; reinterventions; 
return to activities. 
Complications and adverse events: 
• 
Early complications (<=30 days): hematoma, superficial/deep infection, wound dehiscence, 
complex regional pain syndrome. 

Single-center retrospective descriptive case series study of clavicle nonunion: epidemiology, 
surgical management, and functional outcomes | NCT__________ (if available) | Document 
date: 15 January 2026 | Version 1 
 
• 
Late complications: implant failure, persistent nonunion, secondary septic nonunion, 
stiffness. 
• 
Reinterventions (date, indication, procedures performed). 
• 
Hardware removal (yes/no; indication; time from surgery). 
Resources consumed (organizational impact): 
• 
Number of consultations (pre-/post-operative). 
• 
Number of imaging exams (radiographs, CT). 
• 
Cumulative sick leave (days). 
• 
Total hospitalization duration (days). 
Photos/videos/audio recordings: No. 
Data preparation 
The coordinator will identify eligible subjects from CHU de Brest medical records, maintain a 
correspondence table for included subjects, and enter the pseudonymized data to be analyzed 
into the study database. 
No transfer of data outside CHU de Brest will be performed. 
Methods, processing, and data analysis 
Software/tools: 
Analyses will be conducted in R (>= 4.3) and cross-checked in Python. R is chosen for 
reproducibility (version-controlled scripts) and suitability for small samples and censored data. 
Methods: 
• 
Descriptive statistics: mean +/- SD or median [IQR]; counts and percentages. Proportions 
(e.g., union at 6 months) will be reported with 95% confidence intervals. 
• 
Time to union: Kaplan-Meier curves; Cox regression modeling. 
• 
Exploratory comparisons: Fisher’s exact test for categorical variables; Mann-Whitney U test 
(or Student’s t-test) for continuous variables. 
• 
Multivariable analyses: Cox regression for time to union; linear regression for 
Constant/DASH scores. 
Study limitations 
Potential limitations include the retrospective single-center design and small sample size (~30). 
Design-related limitations and mitigation: 
• 
Selection bias (only operated cases; loss to follow-up): define inclusion/exclusion criteria a 
priori; provide a flowchart of exclusions/losses; compare included vs non-included when 
possible. 

Single-center retrospective descriptive case series study of clavicle nonunion: epidemiology, 
surgical management, and functional outcomes | NCT__________ (if available) | Document 
date: 15 January 2026 | Version 1 
 
• 
Indication bias (technique chosen based on patient profile): stratified analyses (plate alone 
vs graft; septic vs aseptic). 
• 
Temporal heterogeneity (changes in implants/techniques over 2000-2025). 
• 
Single-center (limited external validity): provide detailed description of local context and 
discuss generalizability versus literature. 
Data-source limitations and mitigation: 
• 
Information/classification bias (incomplete/heterogeneous records): standard operational 
definitions (union; septic vs aseptic nonunion); data dictionary; double review of a random 
sample (>=10%) with discrepancy resolution. 
• 
Outcome measurement (clinico-radiographic union; functional scores not always available): 
specify assessment windows (4-8 months); document information source (clinical vs 
imaging); define a functional sub-cohort a priori. 
• 
Radiographic assessment variability: standardized reading grids; blinded review by two 
trained readers. 
Analytical limitations: 
• 
Small sample / low number of events (risk of overfitting). 
• 
Missing data (particularly functional scores). 
• 
Potential informative censoring / variable follow-up. 
• 
Limited causal inference (non-randomized; residual confounding). 
• 
Reproducibility: analyses will be scripted and version-controlled. 
Planned timeline and feasibility 
Key project milestones and estimated timeline: 
Step 
Description 
Dates 
Duration 
Authorization 
Receipt of authorization 
(CPP/DPO/Management) 
31/01/2026 
- 
Participant 
information 
D0 = 05/02/2026 (letters 
+ transparency portal) - 
statutory period 
05/02/2026 to 
04/04/2026 
2 months 
Data extraction and 
entry 
Extract records and 
imaging (PACS), 
operative reports; enter 
CRF/REDCap; quality 
control 
05/04/2026 to 
31/07/2026 
4 months 
Data analysis 
Database lock; R/Python 
analyses; figures and 
tables 
01/08/2026 to 
30/09/2026 
2 months 
Writing and 
reporting 
Internal report and 
manuscript/presentation 
10/2026 to 12/2026 
3 months 
Results presentation 
Thesis presentation / 
15/01/2027 
- 

Single-center retrospective descriptive case series study of clavicle nonunion: epidemiology, 
surgical management, and functional outcomes | NCT__________ (if available) | Document 
date: 15 January 2026 | Version 1 
 
main oral 
communication 
Planned end of study 
Official date (after 
database lock and 
analyses) 
30/09/2026 
- 
Database destruction 5 years after end of 
study 
30/09/2031 
- 
Feasibility: 
• 
Team: 2 orthopaedic surgeons (shoulder/trauma), 1 resident plus 1 senior surgeon (Dr 
Yvinou) for data collection, and a biostatistician (Dr Letissier). 
• 
Resources: access to PACS and medical records; R >= 4.3 and Python 3.11 environments; 
restricted hospital storage; pseudonymization. 
• 
Volume: about 30 cases - exhaustive data extraction in 4 months; analyses in 2 months. 
• 
Risk control: random double review of at least 10% of cases. 
Privacy, security, and confidentiality of data 
Respect for data subject rights 
Patients will be informed in a complete and fair manner, using understandable terms, about the 
objectives of the research and their rights through at least one of the following methods. 
• 
Information via the hospital website (transparency portal) 
• 
Eligible patients may be informed through an information notice published on the 
hospital transparency portal. In case of objection, it will be forwarded to the hospital 
Data Protection Officer (DPO) without delay. The coordinator will also ensure that 
patients who have previously objected to systematic reuse of their data for research are 
excluded (via the local 'non-objection verification' process). If no objection is received 
from patients or their legal representatives within one month, data collection will be 
implemented. 
• 
Eligible patients for this website-based information are those who consulted or were 
hospitalized at CHU de Brest at least once since September 2025, having received 
generic information about the transparency portal and possible data reuse for research. 
• 
Information via postal letter 
• 
Patients may be informed by postal letter. In case of objection, it will be forwarded to 
the DPO without delay. Patients who have previously objected to systematic reuse of 
their data for research will be excluded and not contacted. If no objection is received 
within one month, data collection will be implemented. 
• 
Information handed directly to the patient 

Single-center retrospective descriptive case series study of clavicle nonunion: epidemiology, 
surgical management, and functional outcomes | NCT__________ (if available) | Document 
date: 15 January 2026 | Version 1 
 
• 
The information notice may be handed directly to patients by qualified hospital staff. If a 
patient objects after inclusion, the objection will be transmitted to the DPO without 
delay. If no objection is received, data collection will be implemented. 
Additional remarks: 
• 
For minors, an age-appropriate version of the information notice will be provided; each legal 
representative will be informed. 
• 
For deceased persons, data may be reused for this research without prior information, 
except for persons who died before 2019 (date of the generic information campaign on data 
reuse at CHU de Brest) or if the person (or representatives) expressed written refusal during 
life. 
• 
Undelivered postal letters (e.g., unknown address): persons will not be considered informed 
and will not be included. 
• 
Non-responsive patients (coma, etc.) at the time of data collection: persons will not be 
considered informed and will not be included. 
• 
DPO contact: protection.donnees@chu-brest.fr 
Selected information method(s): 
• 
Website transparency portal notice (eligible patients only): Not selected 
• 
Postal letter: Selected 
• 
Hand-delivered notice: Not selected 
Confidentiality and data security 
Management of re-identification risk 
The correspondence table contains identity, inclusion number, and postal address (if postal 
notification is used). It is an Excel file protected by a password and stored in a study-specific 
folder on a secure CHU de Brest server. Entry and access are restricted to members of the care 
team for included subjects, using named user sessions. No transfer of this file is permitted. 
Study database: 
• 
Content: study data and subject inclusion number only (pseudonymized data; no names or 
contact details). 
• 
Format, protection, and hosting: password-protected Excel file (with a password different 
from the correspondence table), stored in a study-specific folder on a secure CHU de Brest 
server. 
• 
Data entry: performed only by members of the care team because entry requires 
consultation of nominal medical records. 
• 
Access: restricted to CHU de Brest staff involved in the study, through named user sessions. 

Single-center retrospective descriptive case series study of clavicle nonunion: epidemiology, 
surgical management, and functional outcomes | NCT__________ (if available) | Document 
date: 15 January 2026 | Version 1 
 
• 
Data analysis: conducted only by CHU de Brest staff using local software. If online tools are 
used, no variable names will be entered online. 
• 
Transfer: no transfer outside CHU de Brest. If needed, internal transfer will be done via the 
secure BlueFiles platform. 
Persons with access to the correspondence table: 
• 
Dr Agathe Yvinou 
• 
Dr Hoel Letissier 
• 
Resident Anaelle Kopp 
Data media 
Data will be hosted on the hospital’s secure server with protected access. 
Archiving 
The study data file may be retained on the institution’s shared network by the data 
controller/investigator until two years after the last publication of study results, or, if no 
publication occurs, until the date results are presented. 
In addition, the data file and all study documents will be archived by the investigator for five 
years after the end of the study. 
Archiving consists of retaining a copy of the data on secure IT media controlled by the data 
controller, with access restricted to necessary personnel. 
Appendices 
Appendices include: 
• 
Information notice provided to data subjects, where applicable. 
• 
Study case report form (CRF). 
• 
Bibliography. 
Bibliography: 
• 
Wiss DA, Garlich JM. Clavicle nonunion: plate and graft type do not affect healing rates-a 
single surgeon experience with 71 cases. J Shoulder Elbow Surg. 2021;30(3):679-684. 
doi:10.1016/j.jse.2020.06.035. 
• 
Hollo D, Kolling C, Audige L, Moro F, Rikli D, Muller AM. Plating and cortical bone grafting of 
clavicular nonunions: clinical outcome and its relation to clavicular length restoration. JSES 
Int. 2020;4(3):508-514. doi:10.1016/j.jseint.2020.04.002. 
• 
Song HS, Kim H. Current concepts in the treatment of midshaft clavicle fractures in adults. 
Clin Shoulder Elb. 2021;24(3):189-198. doi:10.5397/cise.2021.00388. 

Single-center retrospective descriptive case series study of clavicle nonunion: epidemiology, 
surgical management, and functional outcomes | NCT__________ (if available) | Document 
date: 15 January 2026 | Version 1 
 
• 
Muhlenfeld N, Wagner FC, Hupperich A, Heykendorf L, Frodl A, Obid P, et al. Clavicle Shaft 
Non-Unions-Do We Even Need Bone Grafts? J Clin Med. 2024;13(16):4850. 
doi:10.3390/jcm13164850. 
• 
de Reus DC, Wagner RK, Tutuhatunewa E, Musick AN, Gregg AT, Janssen SJ, et al. Outcomes 
of clavicle nonunion repair: a retrospective cohort study of 125 patients. J Orthop Trauma. 
2025 May 6;Epub ahead of print. doi:10.1097/BOT.0000000000003007. 
• 
Chiang J, Karunaratne YG, Romeo P, Sim ITM, Graham D, Sivakumar B. Vascularized bone 
reconstruction for recalcitrant clavicular nonunion: a systematic review of the literature. 
Ann Plast Surg. 2025;94(2):229-235. Epub 2024 Nov 7. doi:10.1097/SAP.0000000000004130. 
• 
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PSEUDO-CLAV - ENR-XXX_V1 - 14 August 2025
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Study Document
Patient Information Notice / Right to Object
(Retrospective Study)
Official Title of Study:
Single-center retrospective descriptive study of a case series
of clavicle nonunion: epidemiology, surgical management,
and functional outcomes
Study Acronym:
PSEUDO-CLAV
NCT Number (if available):
Not yet assigned
Sponsor / Data Controller:
Brest University Hospital (CHU Brest)
Principal Investigator /
Scientific Lead:
Dr Agathe Yvinou, Orthopaedic and Trauma Surgery, Brest
University Hospital (CHU Brest)
Document Type:
Patient information notice (right to object / opt-out
information sheet)
Document Date:
14 August 2025
Version:
ENR-XXX_V1
This document provides information about the use of previously collected health data for research. You may
object to the use of your data at any time, as described in the document.

PSEUDO-CLAV - ENR-XXX_V1 - 14 August 2025
Page 2
INFORMATION NOTICE
PSEUDO-CLAV Study
Single-center retrospective descriptive study of a case series of clavicle nonunion: epidemiology,
surgical management, and functional outcomes
Data Controller: Brest University Hospital (CHU Brest)
Scientific Lead
Dr Agathe Yvinou
Orthopaedic and Trauma Surgery
Brest University Hospital (CHU Brest)
CHU Brest Data Protection Officer (DPO) Contact
DPO email address: protection.donnees@chu-brest.fr
Dear Sir or Madam,
CHU Brest is the sponsor of a research study entitled “PSEUDO-CLAV” under the scientific
responsibility of Dr Agathe Yvinou.
This study will be conducted using your health data that were already collected during your care at
CHU Brest. It does not involve any direct contact with you, nor any modification of your care.
However, you have the option to object to the use of your data for this study.
If you do not wish your data to be included in the study, simply inform the CHU Brest Data
Protection Officer or the study’s scientific lead. This decision will have no consequences for your
relationship with the medical and nursing teams, nor for the quality of your current or future care.
You do not need to provide a reason.
What is the purpose of the research?
The aim of this study is to describe the clinical, radiological, and therapeutic characteristics of
clavicle nonunions treated surgically in our center, and to estimate the bone union rate after
surgery, in order to improve knowledge and medical practice in this field.
What data will be used?
The data used in this study come from your medical record. They include medical information
(history of the trauma, medical and surgical history, steps of medical and surgical management,
laboratory data such as blood test and bacteriology results, antibiotics received, multidisciplinary
meeting reports), surgical information (types of surgery and dates, types of implants and grafts),
and radiological information (imaging examinations performed and their interpretation).
These data will be pseudonymized, meaning they will be coded and will not include your first or last
name. They will be processed confidentially, only by authorized members of the research team, for
scientific purposes only.
Who will have access to the data?

PSEUDO-CLAV - ENR-XXX_V1 - 14 August 2025
Page 3
Authorized members of the research team who perform the analyses will have access to the study
data in coordination with the scientific lead. All these individuals are bound by professional secrecy
and confidentiality.
The results will be published in scientific journals and/or presented at conferences. They will
always be presented in an aggregated manner so that it will be impossible to identify an individual
participant in the study.
How will the study be conducted and how will your data be protected?
A computerized file containing only the data strictly necessary for the study will be created within
CHU Brest. Your first and last names will not appear in this file.
Only authorized members of the research team will be able to access the data. Access to the
database will be secured by an individual password. Analyses will always be carried out
confidentially. No individual data will be extracted from the database.
The results of the study will improve current knowledge and optimize the management of patients
who may experience the same medical situation as you did.
Your health data collected for this research will be kept and archived for a maximum of 5 years
after the end of the study.
What are your rights?
In accordance with the French Data Protection Act of January 6, 1978 (as amended) and the
General Data Protection Regulation (GDPR) of April 27, 2016, you have the right to access, rectify,
and restrict the processing of your data.
These rights may be exercised through the Data Protection Officer.
You may object at any time to the processing of your data for this study, provided that analyses are
not already underway or completed.
A minimum period of 30 days between dissemination of this information notice and the start of
analyses will be respected to allow you to exercise your right to object.
If you have any questions about your rights, you may contact our Data Protection Officer. You also
have the right to lodge a complaint with the French Data Protection Authority (CNIL) if you consider
that your rights are not being respected.
What is the regulatory framework for this study?
This study received a favorable opinion from the CRET (Comité de Réflexion Ethique de Territoire).
It is conducted as part of a public-interest mission entrusted to CHU Brest.
The processing implemented in the context of this research complies with the regulatory provisions
allowing a healthcare institution to process data for scientific research purposes (Article 9(2) of the
GDPR).
Future collaborations and other possible uses

PSEUDO-CLAV - ENR-XXX_V1 - 14 August 2025
Page 4
As part of future scientific collaborations, CHU Brest may share coded data with institutional or
industrial teams in France or abroad, or make them available on a secure research-dedicated
website, in accordance with points (i) and (j) of Article 9(2) of the GDPR.
If your data are transferred to a country outside the EU, CHU Brest undertakes to ensure an
adequate level of protection of personal data in accordance with applicable regulations.
You may also object at any time to the use of your health data for other research, activity analyses,
or future studies conducted by the care team or other authorized professionals, under the
responsibility of a physician.
Finally, you may request access to your medical record in accordance with Article L1111-7 of the
French Public Health Code and the GDPR.
How to object to the use of your data for the PSEUDO-CLAV study
- By email: protection.donnees@chu-brest.fr
- Via the transparency portal: Transparency portal (chu-brest.fr) - https://transparence.chu-brest.fr/
- By contacting the scientific lead: Dr Agathe Yvinou
- By post: CHU Brest, Hôpital Morvan, Direction Générale / DPO, 2 avenue Foch, 29609 Brest,
France
Template letter to send by email or post
First name / Last name:
Date of birth:
Place of birth:
I object to the use of my health data collected during my care for this research.
Date: ____________________________ Signature: ____________________________