Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Surgical Innovations in Treatment of Clavicle Fractures (ClavFrac)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02247778
Recruitment Status : Unknown
Verified September 2014 by Dr. Chlodwig Kirchhoff, Technische Universität München.
Recruitment status was:  Recruiting
First Posted : September 25, 2014
Last Update Posted : September 30, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Chlodwig Kirchhoff, Technische Universität München

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.


Condition or disease Intervention/treatment Phase
Complication Procedure: conventional plate osteosynthesis Procedure: mini-incision-type osteosynthesis Not Applicable

Detailed 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcome of Mini-incision-technique for Treatment of Midshaft Fractures of the Clavicle
Study Start Date : April 2014
Actual Primary Completion Date : September 2014
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Active Comparator: conventional plate osteosynthesis
Standard procedure
Procedure: conventional plate osteosynthesis
Standard incision

Active Comparator: mini-incision-type osteosynthesis
mini-incision
Procedure: mini-incision-type osteosynthesis
Mini-incision




Primary Outcome Measures :
  1. area of paresthetic skin [ Time Frame: 12 month ]

Secondary Outcome Measures :
  1. Time to fracture healing [ Time Frame: 12 month ]
  2. Postoperative shoulder function [ Time Frame: 12 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


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): NCT02247778


Contacts
Layout table for location contacts
Contact: Chlodwig Kirchhoff, MD chlodwig.kirchhoff@mri.tum.de
Contact: Marc Beirer, MD marc.beirer@mri.tum.de

Locations
Layout table for location information
Germany
Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar Recruiting
Munich, Bavaria, Germany, 81675
Contact: Peter Biberthaler, MD    0049-(0)89-41402126    peter.biberthaler@mri.tum.de   
Principal Investigator: Chlodwig Kirchhoff, MD         
Sponsors and Collaborators
Technische Universität München
Investigators
Layout table for investigator information
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):
Layout table for additonal information
Responsible Party: Dr. Chlodwig Kirchhoff, PD DR. med. Chlodwig Kirchhoff, Technische Universität München
ClinicalTrials.gov Identifier: NCT02247778     History of Changes
Other Study ID Numbers: Beiromat_02
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: September 30, 2014
Last Verified: September 2014
Keywords provided by Dr. Chlodwig Kirchhoff, Technische Universität München:
clavicle
surgical intervention
mini-incision
plate osteosynthesis