Clavicular Length Clinical Trial
Official title:
The Impact of Clavicular Length Restoration in the Treatment of Non-unions of Clavicular Midshaft and Lateral Fractures
| Verified date | April 2019 |
| Source | University Hospital, Basel, Switzerland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 46 |
| Est. completion date | September 25, 2018 |
| Est. primary completion date | September 25, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Department of Orthopaedics | Basel | |
| Switzerland | Schulthess Klinik Zürich | Zürich |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Basel, Switzerland |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |