Descriptive Single-center Retrospective Study of a Series of Cases of Clavicle Pseudarthrosis: Epidemiology, Surgical Management, and Functional Outcomes

NCT07414654 | Active Not Recruiting

• 1 other identifier: 29BRC25.0396 - PSEUDO-CLAV
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Study identification Study title: PSEUDO-CLAV - Single-center retrospective descriptive study of clavicle nonunion (pseudarthrosis): epidemiology, surgical management, and functional outcomes PSEUDO-clav\_Notice non oppositi… Study type: Observational study (retrospective, single-center) using existing medical records and imaging Study sponsor / data controller: CHU de Brest Scientific lead (principal investigator): Dr Agathe YVINOU (Orthopaedic \& Trauma Surgery, CHU de Brest) Data Protection Officer (DPO) contact: protection.donnees@chu-brest.fr
2. 2.Why is this study being done?
3. 3.Goal of the study (use/keep this "fill-in" format) The goal of this observational study is to describe clavicle nonunion cases treated surgically at CHU de Brest and to estimate how often the clavicle heals after surgery, using information already collected during routine care.
4. 4.Who may be included? (participant population)
5. 5.What will participants have to do?
6. 6.What information will be used?
7. 7.Risks and benefits Risks to for the patients : Since no new procedures are done, the main risk is related to privacy/confidentiality of data. The study team puts protections in place to reduce this risk (see below).
8. 8.How will privacy be protected? Data used for analysis will be pseudonymized (coded). Name and first name are not included in the research dataset.
9. 9.Voluntary nature and patient's rights

Conditions

Pseudarthrosis; Clavicle Fracture; Clavicle Fracture, Non Union/Malunion

Outcome Measures

Primary Outcomes (1)

• Clavicle union (consolidation) at 6 months after index nonunion surgery

  Binary outcome (Yes/No): whether the clavicle nonunion has consolidated at \~6 months (T6) after the index surgery for clavicle pseudarthrosis, using a predefined assessment window of 4-8 months. Consolidation is defined clinically and radiographically based on routine follow-up documentation and imaging (e.g., post-operative visits around T+6 weeks, T+3-4 months, and T+6 months with recorded clinical/radiographic consolidation).

  2000 - 2024

Secondary Outcomes (9)

• Time to first documented clavicle union (consolidation)

  2000 - 2024

• Shoulder range of motion over follow-up

  2000 - 2024

• Return to activities (yes/no)

  2000 - 2024

• Return to sports/activities (time to return)

  2000 - 2024

• Return to work (yes/no)

  2000-2024

Study Arms (1)

Adults (≥18) surgically treated for clavicle nonunion at CHU Brest (2000-2024)

Retrospective single-center cohort of adults who underwent surgery for clavicle nonunion (pseudarthrosis) at CHU de Brest between 01/01/2000 and 31/12/2024. Interventions of interest include nonunion revision surgery (e.g., plate fixation ± bone graft and related techniques) performed as part of routine care; outcomes assessed from existing records and imaging.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retrospective, single-center study including adults (≥18 years) treated at CHU de Brest who underwent surgical management of clavicle nonunion (pseudarthrosis), aseptic or septic, between 01/01/2000 and 31/12/2024. Eligible cases have documented clinical and radiographic nonunion and sufficient perioperative records and imaging to assess outcomes. Patients who object to the reuse of their data, are under legal protection, are \<18 years old, have congenital or pathologic pseudarthrosis, or were managed without surgery are not included.

You may qualify if:

• Setting \& period: Managed at CHU de Brest (Orthopaedics-Traumatology) and operated for clavicle nonunion between 01/01/2000 and 31/12/2024.
• Age: ≥ 18 years at the time of the index nonunion surgery.
• Diagnosis: Clavicle pseudarthrosis (nonunion) documented in the record, defined as no clinical and radiographic union ≥6 months after the initial fracture, or radiographic signs of nonunion (e.g., gap, no bridging callus, sclerotic ends) with compatible symptoms.
• Index treatment: Surgical management of the pseudarthrosis (e.g., osteosynthesis with/without bone graft, vascularized graft, other reconstructive technique).
• Minimum data available: Pre- and/or peri-operative imaging confirming nonunion and at least one postoperative clinical and/or radiographic assessment (any timing).
• Scope: Aseptic and/or septic clavicle nonunions are eligible.
• Legal protection: Adults under legal protection (sauvegarde de justice/curatelle/tutelle).
• Patient objection: Any opposition to the use of their data.
• Age \< 18 years.
• Non-surgical management only of the nonunion (conservative treatment without surgery).
• Acute fractures (\<6 months) without nonunion criteria, or delayed union without pseudarthrosis criteria.
• Pathologic fracture (tumor/metastasis) or congenital clavicle pseudarthrosis.
• Care outside the study period and/or outside CHU de Brest.
• Insufficient documentation to evaluate exposure and/or the primary outcome: no usable pre- or post-op imaging and no postoperative follow-up available (immediate loss to follow-up).
• Early death unrelated to the condition/surgery before any postoperative assessment.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

Chu Brest

Brest, 29200, France

Location

MeSH Terms

Conditions

Pseudarthrosis

Condition Hierarchy (Ancestors)

Fractures, Ununited; Fractures, Bone; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: February 17, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

Locations

FR (1)