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

Completed

• Conditions: Fracture, Closed, Comminuted, Healing
• Interventions: Procedure: Plate osteosynthesis

• Registration Number: NCT02256059
• Lead Sponsor: Technical University of Munich

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.

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2013-09
• Status Verified: 2014-09
• Study Completion: 2014-09
• Study First Submitted: 2014-09-28
• Study First Submitted QC: 2014-09-30
• Last Update Submitted: 2014-09-30
• Study First Posted: 2014-10-03
• Last Update Posted: 2014-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Plate osteosynthesis	Plate osteosynthesis	Patients with fracture of the lateral clavicle and indication for surgical treatment

Primary Outcome Measures

Name	Time	Method
bone healing	12 month	time until bone healing, visualized using conventional x-ray in two planes

Secondary Outcome Measures

Name	Time	Method
shoulder function	12 month	shoulder function assessed using Munich Shoulder Questionnaire \[MSQ\]

Trial Locations

Locations (1)

Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar; 🇩🇪 Munich, Bavaria, Germany