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

Fracture, Closed, Comminuted, Healing Clinical Trial

— LatClav  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02256059
• Other study ID #: Beiromat_03
• Status: Completed
• Phase: N/A
• First received: September 28, 2014
• Last updated: September 30, 2014
• Start date: June 2011
• Est. completion date: September 2014

Study information

• Verified date: September 2014
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fracture, Closed, Comminuted, Healing
• Fractures, Bone
• Fractures, Closed

Intervention

Procedure:
• Plate osteosynthesis
Plate osteosynthesis using LCP plate (Synthes)

Locations

Country	Name	City	State
Germany	Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone healing	time until bone healing, visualized using conventional x-ray in two planes	12 month	Yes
Secondary	shoulder function	shoulder function assessed using Munich Shoulder Questionnaire [MSQ]	12 month	No