Surgical Innovations in Treatment of Clavicle Fractures
ClavFrac
Outcome of Mini-incision-technique for Treatment of Midshaft Fractures of the Clavicle
1 other identifier
interventional
40
1 country
1
Brief Summary
Surgical incision for plate osteosynthesis of midshaft fractures of the clavicle averages 7 to 8 centimeters in the literature. It is hypothesized, that depending on the invasiveness of this incision secondary problems like prolonged fracture healing, paresthesia of supraclavicular nerves and pain due to scar tissue increase. Therefore we developed a mini-incision technique using an average incision length of 4cm. The aim of this study is to analyzed whether secondary problems following plate osteosynthesis of the clavicle correlate mit the length of the surgical access.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 21, 2014
CompletedFirst Posted
Study publicly available on registry
September 25, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedSeptember 30, 2014
September 1, 2014
5 months
September 21, 2014
September 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
area of paresthetic skin
12 month
Secondary Outcomes (2)
Time to fracture healing
12 month
Postoperative shoulder function
12 month
Study Arms (2)
conventional plate osteosynthesis
ACTIVE COMPARATORStandard procedure
mini-incision-type osteosynthesis
ACTIVE COMPARATORmini-incision
Interventions
Eligibility Criteria
You may qualify if:
- all patients with fractures of the clavicle and indication for operative intervention using plate osteosynthesis ability to sign informed consent
You may not qualify if:
- all other patients
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, Postl L, Cronlein M, Siebenlist S, Huber-Wagner S, Braun KF, Biberthaler P, Kirchhoff C. Does a minimal invasive approach reduce anterior chest wall numbness and postoperative pain in plate fixation of clavicle fractures? BMC Musculoskelet Disord. 2015 May 28;16:128. doi: 10.1186/s12891-015-0592-4.
PMID: 26018526DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Chlodwig Kirchhoff, MD
Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD DR. med. Chlodwig Kirchhoff
Study Record Dates
First Submitted
September 21, 2014
First Posted
September 25, 2014
Study Start
April 1, 2014
Primary Completion
September 1, 2014
Study Completion
September 1, 2015
Last Updated
September 30, 2014
Record last verified: 2014-09