Fracture, Closed, Comminuted, Healing
Conditions
Brief summary
Treatment of lateral fractures of the clavicle is challenging and has been controversially discussed for a long time due to high non-union rates in non-operative treatment and high complication rates in surgical treatment. A recently developed implant was proven to ensure a biomechanically sufficient fixation of fractures leading to bony union and promising functional outcome in a small collective of patients.
Detailed description
Treatment of lateral fractures of the clavicle is challenging and has been controversially discussed for a long time due to high non-union rates in non-operative treatment and high complication rates in surgical treatment. A recently developed implant was proven to ensure a biomechanically sufficient fixation of fractures leading to bony union and promising functional outcome in a small collective of patients. In this prospective study patients with dislocated fractures of the lateral clavicle (Jäger&Breitner I-III, Neer I-III) are enrolled. All patients are surgically treated using the locking compression plate (LCP) for the superior anterior clavicle (Synthes®). Functional outcome is recorded using the Munich Shoulder Questionnaire (MSQ) allowing for qualitative self-assessment of the Shoulder Pain and Disability Index (SPADI), of the Disability of the Arm, Shoulder and Hand (DASH) score and of the Constant Score. Acromioclavicular joint stability is evaluated using the Taft-Score.
Interventions
Plate osteosynthesis using LCP plate (Synthes)
Sponsors
Study design
Eligibility
Inclusion criteria
* Dislocated fracture of the lateral clavicle * Informed consent.
Exclusion criteria
* Patients with a history of any other pathology such as preexisting rotator cuff tear, gleno-humeral instability, glenohumeral osteoarthritis (\> Samilson I), Acromioclavicular joint instability, Acromioclavicular osteoarthritis, calcifying tendonitis, biceps pathology or signs of cervical root symptoms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bone healing | 12 month | time until bone healing, visualized using conventional x-ray in two planes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| shoulder function | 12 month | shoulder function assessed using Munich Shoulder Questionnaire \[MSQ\] |
Countries
Germany