Clinical trial NCT02256059: Treatment of Displaced Lateral Clavicle Fractures Using a Locking Compression Plate With Lateral Extension
Official title: Treatment of Displaced Lateral Clavicle Fractures Using a Locking Compression Plate With Lateral Extension - Clinical Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fracture, Closed, Comminuted, Healing
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2014-10-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from a dislocated fracture of the lateral clavicle presenting at our emergency department.

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.

Eligibility criteria: 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

Primary outcomes:
measure: bone healing
timeFrame: 12 month
Secondary outcomes:
measure: shoulder function
timeFrame: 12 month
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar
state: Bavaria
Study officials:
affiliation: Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München
name: Chlodwig Kirchhoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beirer M, Siebenlist S, Cronlein M, Postl L, Huber-Wagner S, Biberthaler P, Kirchhoff C. Clinical and radiological outcome following treatment of displaced lateral clavicle fractures using a locking compression plate with lateral extension: a prospective study. BMC Musculoskelet Disord. 2014 Nov 19;15:380. doi: 10.1186/1471-2474-15-380.