Surgical Innovations in Treatment of Clavicle Fractures

Complication Clinical Trial

— ClavFrac  

Official title:

Outcome of Mini-incision-technique for Treatment of Midshaft Fractures of the Clavicle

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02247778
• Other study ID #: Beiromat_02
• Status: Recruiting
• Phase: N/A
• First received: September 21, 2014
• Last updated: September 28, 2014
• Start date: April 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2014
• Source: Technische Universität München
• Contact: Chlodwig Kirchhoff, MD
• Email: chlodwig.kirchhoff[@]mri.tum.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Description:

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. Therefore a prospective observational protocol was chosen.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

all patients with fractures of the clavicle and indication for operative intervention using plate osteosynthesis ability to sign informed consent

Exclusion Criteria:

all other patients

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complication

Intervention

Procedure:
• conventional plate osteosynthesis
Standard incision
• mini-incision-type osteosynthesis
Mini-incision

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	area of paresthetic skin		12 month	Yes
Secondary	Time to fracture healing		12 month	Yes
Secondary	Postoperative shoulder function		12 month	Yes