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

NCT ID: NCT02256059

Last Updated: 2014-10-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2014-09-30

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.

Conditions

Fracture, Closed, Comminuted, Healing

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Plate osteosynthesis

Patients with fracture of the lateral clavicle and indication for surgical treatment

Plate osteosynthesis

Intervention Type: PROCEDURE

Plate osteosynthesis using LCP plate (Synthes)

Interventions

Plate osteosynthesis

Plate osteosynthesis using LCP plate (Synthes)

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Dr. Chlodwig Kirchhoff

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chlodwig Kirchhoff, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München

Locations

Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar

Munich, Bavaria, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 25406639 (View on PubMed)

Other Identifiers

Beiromat_03

Identifier Type: -

Identifier Source: org_study_id