The Impact of Clavicular Length Restoration in the Treatment of Non-unions of Clavicular Midshaft and Lateral Fractures

Study Overview
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Brief Summary
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Evaluating the impact of plate treatment and cortical bone grafting of clavicular midshaft and lateral non- unions on restoration of clavicular length and bony healing and its association with functional outcome.

Official Title
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The Impact of Clavicular Length Restoration in the Treatment of Non-unions of Clavicular Midshaft and Lateral Fractures

Conditions
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Clavicular Length

Intervention / Treatment
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* Other: Follow- up (FU) assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting minimal follow- up of two years after surgery written informed consent Exclusion Criteria: legal incompetence non- union of pathologic fractures current pregnancy German language barrier to complete questionnaires

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Follow- up (FU) assessment on clavicular non- union<br>clavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting | Other: Follow- up (FU) assessment<br>* Follow- up (FU) assessment (clinical examination and patient questionnaires) at least 24 months after surgery (clavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clavicula shortening (cm) | Clavicula shortening (cm) based on Imaging assessment (x-ray, ultrasound), dichotomous outcome with shortening less or equal 2 cm (yes/no). | one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Murley score (CS) | tool for assessment of shoulder function: Range of Motion (ROM) of shoulder (degree), abduction strength (kg), Quality of Life (QoL) questionnaire. The different scales are summed and normalized to 0=worst to 100=best. | one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting | 
| Subjective shoulder pain (NRS) | Patient rates pain at rest and at motion of the treated shoulder on numeric scale ranging from 0 (no pain) to 10 (maximum possible pain) | one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting | 
| Subjective shoulder value (SSV) | based on a single question answered subjectively by Patient: What is the overall percent value of your shoulder if a completely normal shoulder represents 100%? | one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting | 
| Simple shoulder test (SST) | 12 items questionnaire to assess restrictions in activities of daily living (ADL) related to impaired shoulder function; response in dichotomous manner (yes/no) | one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting | 
| Quality of Life (QoL) | assessed by Quality of Life EuroQoL 5D-5L Instrument (EQ-5D-5L); the descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. | one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clavicle non-unions, plate treatment of clavicular fractures, cortical bone grafting of clavicular fractures, clavicular midshaft non- union, clavicular lateral non- union, clavicular shortening