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

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ClinicalTrials.gov Identifier: NCT02256059
Recruitment Status : Completed
First Posted : October 3, 2014
Last Update Posted : October 3, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Chlodwig Kirchhoff, Technische Universität München

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.

Condition or disease Intervention/treatment
Fracture, Closed, Comminuted, Healing Procedure: Plate osteosynthesis

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.


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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Displaced Lateral Clavicle Fractures Using a Locking Compression Plate With Lateral Extension - Clinical Observational Study
Study Start Date : June 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Group/Cohort Intervention/treatment
Plate osteosynthesis
Patients with fracture of the lateral clavicle and indication for surgical treatment
Procedure: Plate osteosynthesis
Plate osteosynthesis using LCP plate (Synthes)




Primary Outcome Measures :
  1. bone healing [ Time Frame: 12 month ]
    time until bone healing, visualized using conventional x-ray in two planes


Secondary Outcome Measures :
  1. shoulder function [ Time Frame: 12 month ]
    shoulder function assessed using Munich Shoulder Questionnaire [MSQ]



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suffering from a dislocated fracture of the lateral clavicle presenting at our emergency department.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02256059


Locations
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Germany
Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
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Principal Investigator: Chlodwig Kirchhoff, MD Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Chlodwig Kirchhoff, MD, Technische Universität München
ClinicalTrials.gov Identifier: NCT02256059     History of Changes
Other Study ID Numbers: Beiromat_03
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: October 3, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
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Fractures, Bone
Fractures, Closed
Wounds and Injuries