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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Follow- up (FU) assessment on clavicular non- union | clavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follow- up (FU) assessment | Other | 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) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients surgically treated at the Schulthess Clinic (KWS) and at the University Hospital Basel (USB) for internal fixation with a plate and using iliac bone graft of clavicular non- unions.
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Mueller, PD Dr. med | Orthopädische Universitätsklinik Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopaedics | Basel | 4031 | Switzerland | |||
| Schulthess Klinik Zürich |
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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| 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 |
| Zurich |
| 8008 |
| Switzerland |