Treatment of Displaced Lateral Clavicle Fractures Using a Locking Compression Plate With Lateral Extension
LatClav
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 28, 2014
CompletedFirst Posted
Study publicly available on registry
October 3, 2014
CompletedOctober 3, 2014
September 1, 2014
2.3 years
September 28, 2014
September 30, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
bone healing
time until bone healing, visualized using conventional x-ray in two planes
12 month
Secondary Outcomes (1)
shoulder function
12 month
Study Arms (1)
Plate osteosynthesis
Patients with fracture of the lateral clavicle and indication for surgical treatment
Interventions
Eligibility Criteria
Patients suffering from a dislocated fracture of the lateral clavicle presenting at our emergency department.
You may qualify if:
- Dislocated fracture of the lateral clavicle
- Informed consent.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar
Munich, Bavaria, 81675, Germany
Related Publications (1)
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.
PMID: 25406639DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chlodwig Kirchhoff, MD
Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 28, 2014
First Posted
October 3, 2014
Study Start
June 1, 2011
Primary Completion
September 1, 2013
Study Completion
September 1, 2014
Last Updated
October 3, 2014
Record last verified: 2014-09