Surgical Innovations in Treatment of Clavicle Fractures (ClavFrac)

September 28, 2014 updated by: Dr. Chlodwig Kirchhoff, Technical University of Munich

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • Recruiting
        • Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar
        • Contact:
        • Principal Investigator:
          • Chlodwig Kirchhoff, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
area of paresthetic skin
Time Frame: 12 month
12 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to fracture healing
Time Frame: 12 month
12 month
Postoperative shoulder function
Time Frame: 12 month
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Principal Investigator: Chlodwig Kirchhoff, MD, Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Anticipated)

September 1, 2015

Study Registration Dates

First Submitted

September 21, 2014

First Submitted That Met QC Criteria

September 21, 2014

First Posted (Estimate)

September 25, 2014

Study Record Updates

Last Update Posted (Estimate)

September 30, 2014

Last Update Submitted That Met QC Criteria

September 28, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Beiromat_02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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