Treatment of Displaced Lateral Clavicle Fractures Using a... | NCT02256059

Studies
Treatment of Displaced Lateral Clavicle Fractures Using a Locking Compression Plate With Lateral Extension

NCT02256059

Sponsor

Technical University of Munich

Status

Completed

Last Update Posted

Oct 3, 2014Estimated

Enrollment

20Actual

Phase

Not provided

Conditions

Fracture, Closed, Comminuted, Healing

Interventions

Plate 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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Sep 2013Actual

Completion Date

Sep 2014Actual

First Submitted Date

Sep 28, 2014

First Submission Date that Met QC Criteria

Sep 30, 2014

First Posted Date

Oct 3, 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 30, 2014

Last Update Posted Date

Oct 3, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Chlodwig Kirchhoff, MD, 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

Treatment of lateral fractures of the clavicle is challenging and has been controversially discussed for a long time due to high non-union rates in non-operative treatment and high complication rates in surgical treatment. A recently developed implant was proven to ensure a biomechanically sufficient fixation of fractures leading to bony union and promising functional outcome in a small collective of patients.

Detailed Description

In this prospective study patients with dislocated fractures of the lateral clavicle (Jäger&Breitner I-III, Neer I-III) are enrolled. All patients are surgically treated using the locking compression plate (LCP) for the superior anterior clavicle (Synthes®). Functional outcome is recorded using the Munich Shoulder Questionnaire (MSQ) allowing for qualitative self-assessment of the Shoulder Pain and Disability Index (SPADI), of the Disability of the Arm, Shoulder and Hand (DASH) score and of the Constant Score. Acromioclavicular joint stability is evaluated using the Taft-Score.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Plate osteosynthesis		Patients with fracture of the lateral clavicle and indication for surgical treatment	Procedure: Plate osteosynthesis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plate osteosynthesis	Procedure	Plate osteosynthesis using LCP plate (Synthes)	Plate osteosynthesis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
bone healing	time until bone healing, visualized using conventional x-ray in two planes	12 month

Secondary Outcomes

Measure	Description	Time Frame
shoulder function	shoulder function assessed using Munich Shoulder Questionnaire [MSQ]	12 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Dislocated fracture of the lateral clavicle
Informed consent.

Exclusion Criteria:

Patients with a history of any other pathology such as preexisting rotator cuff tear, gleno-humeral instability, glenohumeral osteoarthritis (> Samilson I), Acromioclavicular joint instability, Acromioclavicular osteoarthritis, calcifying tendonitis, biceps pathology or signs of cervical root symptoms

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients suffering from a dislocated fracture of the lateral clavicle presenting at our emergency department.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

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		Munich	Bavaria	81675	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25406639	Derived	Beirer M, Siebenlist S, Cronlein M, Postl L, Huber-Wagner S, Biberthaler P, Kirchhoff C. Clinical and radiological outcome following treatment of displaced lateral clavicle fractures using a locking compression plate with lateral extension: a prospective study. BMC Musculoskelet Disord. 2014 Nov 19;15:380. doi: 10.1186/1471-2474-15-380.

ID	Term
D050723	Fractures, Bone
D018460	Fractures, Comminuted