Descriptive Single-center Retrospective Study of a Series of Cases of Clavicle Pseudarthrosis: Epidemiology, Surgical Management, and Functional Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clavicle union (consolidation) at 6 months after index nonunion surgery
研究概览
简要总结
- 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
- Why is this study being done?
A clavicle nonunion (pseudarthrosis) is when a broken collarbone does not heal as expected and may cause pain, reduced shoulder function, and lower quality of life. Surgery is often used, but because this condition is uncommon, the investigators want to better understand:
who is affected, which surgical strategies are used, how often the bone heals after surgery, what functional recovery and complications look like in real-life practice. 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.
The main questions it aims to answer are:
How often does the clavicle heal ("consolidate") after surgery? Main measure: union rate at ~6 months after surgery (assessment window approximately 4-8 months).
PSEUDO-clav_Protocole_scientifi… How do patients recover in terms of function and symptoms, and what complications occur? Examples: shoulder function scores (Constant and/or DASH), pain, return to work/sport, complications and re-operations.
PSEUDO-clav_Protocole_scientifi…
If there is a comparison group (optional wording):
Researchers may compare different surgical strategies (for example, plate fixation alone vs. plate fixation plus bone graft, and other techniques when used) to explore whether results differ for healing, recovery, or complications.
PSEUDO-clav_Protocole_scientifi… 4. Who may be included? (participant population)
This study may include adults who:
were treated at CHU de Brest, and had surgery for clavicle nonunion between January 1, 2000 and December 31, 2024, and were 18 years or older at the time of the nonunion surgery, and have enough information in the medical record/imaging to evaluate outcomes. PSEUDO-clav_Protocole_scientifi… Estimated number of participants: up to about 30 cases in this center (because the condition is rare).
PSEUDO-clav_Protocole_scientifi… 5. What will participants have to do?
Nothing extra. This study:
uses existing information already in the medical record and imaging systems, involves no additional visits, no extra tests, and no change to treatment, and does not require direct contact with patients. 6. What information will be used?
Information may include (examples):
medical history related to the injury and health conditions, details of the surgery (type of fixation, whether a bone graft was used), lab results (including microbiology if relevant), radiology/imaging reports and images, follow-up notes about pain, function, healing, complications, and re-operations. 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).
Benefits: the patients should not expect a direct personal benefit, because care is not changed. Results may help improve understanding of clavicle nonunion surgery, follow-up practices, and future care decisions. 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.
Only authorized members of the research team can access the data, using secure access (e.g., password-protected files and restricted hospital systems).
Study results will be presented as grouped data, so individuals cannot be identified in publications or conference presentations.
Data retention: research data are kept and archived for a limited duration (e.g., up to 5 years after the end of the study, per the study documentation). 9. Voluntary nature and patient's rights
Because this is a retrospective study using existing records, participation is based on non-opposition (opt-out). The patient can:
object to the use of data for this study, and request access, correction, or limitation of processing as permitted by data protection rules.
How to object (opt out) of PSEUDO-CLAV:
Email the DPO: protection.donnees@chu-brest.fr, or use the CHU Brest transparency portal (as listed in the notice), or contact the study scientific lead, or write to CHU Brest (address listed in the notice). Choosing not to participate will not affect patient's medical care now or in the future
详细描述
Clavicle nonunion (pseudarthrosis) is an uncommon but clinically important complication of clavicle fracture that may lead to persistent pain, limitation of shoulder function, prolonged work disability, and impaired quality of life. Surgical repair is frequently proposed, most commonly using plate fixation with or without bone grafting. However, because the condition is relatively rare, available evidence is largely based on retrospective series and practice varies regarding key technical decisions (e.g., when to add bone graft, how to manage bone defects or loss of length, and how to approach septic versus aseptic nonunion). The PSEUDO-CLAV study has been designed to describe "real-world" management in a single tertiary center and to estimate healing and recovery outcomes after surgical treatment, using routinely collected data.
Overall design and setting PSEUDO-CLAV is a single-center, retrospective, observational cohort/case-series study conducted in the Orthopaedic and Trauma Surgery Department at CHU de Brest. The study reuses data generated during routine care and does not introduce additional visits, tests, or changes in management.
The study period covers patients surgically treated for clavicle nonunion between 01 January 2000 and 31 December 2024, chosen to ensure adequate follow-up for outcome assessment at the time of analysis. Approximately 30 cases are expected based on local incidence and feasibility estimates.
The study scope includes aseptic and septic clavicle nonunions treated surgically, reflecting the full spectrum of cases managed at the center.
Data sources and study procedures (no additional patient burden)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(must meet all) :
- •Setting & period: Managed at CHU de Brest (Orthopaedics-Traumatology) and operated for clavicle nonunion between 01/01/2000 and 31/12/
- •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.
- •Exclusion / non-inclusion criteria (not 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.
- •Exclusion after initial selection (screen-fail after chart review)
- •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.
- •Unclassifiable infection status: suspected infection without microbiologic confirmation and without a clear therapeutic strategy, preventing classification as septic vs aseptic.
- •Major ipsilateral concomitant trauma making functional scores uninterpretable (e.g., severe brachial plexus injury, major scapulothoracic stiffness, recent shoulder arthroplasty).
- •Unresolved duplicates/inconsistent identifiers (same patient-same clavicle).
排除标准
- 未提供
研究组 & 干预措施
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.
结局指标
主要结局
Clavicle union (consolidation) at 6 months after index nonunion surgery
时间窗: 2000 - 2024
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).
次要结局
- 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)
- Return to work (time to return)(2000-2024)
- Patient satisfaction at follow-up(2000 - 2024)
- Early postoperative complications(2000 - 2024)
- Late Postoperative Complications(2000-2024)