Clavicular Length
Conditions
Keywords
clavicle non-unions, plate treatment of clavicular fractures, cortical bone grafting of clavicular fractures, clavicular midshaft non- union, clavicular lateral non- union, clavicular shortening
Brief summary
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.
Interventions
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)
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clavicula shortening (cm) | one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting | Clavicula shortening (cm) based on Imaging assessment (x-ray, ultrasound), dichotomous outcome with shortening less or equal 2 cm (yes/no). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Constant Murley score (CS) | one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting | 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. |
| Subjective shoulder pain (NRS) | one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting | 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) |
| Subjective shoulder value (SSV) | one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting | 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%? |
| Simple shoulder test (SST) | one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting | 12 items questionnaire to assess restrictions in activities of daily living (ADL) related to impaired shoulder function; response in dichotomous manner (yes/no) |
| Quality of Life (QoL) | one assessment at least 24 months after clavicular surgery by plate and iliac crest bone grafting | 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. |
Countries
Switzerland