Clinical Trial: Treatment of Displaced Lateral Clavicle Fractures Using a Locking Compression Plate With Lateral Extension

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Treatment of Displaced Lateral Clavicle Fractures Using a Locking Compression Plate With Lateral Extension - Clinical Observational Study

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 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.

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.


Sponsor: Technische Universität München

Current Primary Outcome: bone healing [ Time Frame: 12 month ]

time until bone healing, visualized using conventional x-ray in two planes


Original Primary Outcome: Same as current

Current Secondary Outcome: shoulder function [ Time Frame: 12 month ]

shoulder function assessed using Munich Shoulder Questionnaire [MSQ]


Original Secondary Outcome: Same as current

Information By: Technische Universität München

Dates:
Date Received: September 28, 2014
Date Started: June 2011
Date Completion:
Last Updated: September 30, 2014
Last Verified: September 2014