Surgical Innovations in Treatment of Clavicle Fractures | NCT02247778

Studies
Surgical Innovations in Treatment of Clavicle Fractures

NCT02247778

Sponsor

Technical University of Munich

Status

Unknown status

Last Update Posted

Sep 30, 2014Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Complication

Interventions

conventional plate osteosynthesis
mini-incision-type osteosynthesis

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2015Estimated

First Submitted Date

Sep 21, 2014

First Submission Date that Met QC Criteria

Sep 21, 2014

First Posted Date

Sep 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2014

Last Update Posted Date

Sep 30, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Chlodwig Kirchhoff, PD DR. med. Chlodwig Kirchhoff, Technical University of MunichPrincipal Investigator

Lead Sponsor

Technical University of MunichOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
conventional plate osteosynthesis	Active Comparator	Standard procedure	Procedure: conventional plate osteosynthesis
mini-incision-type osteosynthesis	Active Comparator	mini-incision	Procedure: mini-incision-type osteosynthesis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
conventional plate osteosynthesis	Procedure	Standard incision	conventional plate osteosynthesis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
area of paresthetic skin		12 month

Secondary Outcomes

Measure	Description	Time Frame
Time to fracture healing		12 month
Postoperative shoulder function		12 month

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chlodwig Kirchhoff, MD	Contact			chlodwig.kirchhoff@mri.tum.de
Marc Beirer, MD	Contact			marc.beirer@mri.tum.de

Overall Officials

Name	Affiliation	Role
Chlodwig Kirchhoff, MD	Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar	Recruiting	Munich	Bavaria	81675	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26018526	Derived	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.