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Surgical Innovations in Treatment of Clavicle Fractures

NCT ID: NCT02247778

Last Updated: 2014-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Complication

Keywords

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clavicle surgical intervention mini-incision plate osteosynthesis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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conventional plate osteosynthesis

Standard procedure

Group Type ACTIVE_COMPARATOR

conventional plate osteosynthesis

Intervention Type PROCEDURE

Standard incision

mini-incision-type osteosynthesis

mini-incision

Group Type ACTIVE_COMPARATOR

mini-incision-type osteosynthesis

Intervention Type PROCEDURE

Mini-incision

Interventions

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conventional plate osteosynthesis

Standard incision

Intervention Type PROCEDURE

mini-incision-type osteosynthesis

Mini-incision

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Dr. Chlodwig Kirchhoff

PD DR. med. Chlodwig Kirchhoff

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chlodwig Kirchhoff, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar, Technische Universität München

Locations

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Klinik und Poliklinik für Unfallchirurgie, Klinikum rechts der Isar

Munich, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Chlodwig Kirchhoff, MD

Role: CONTACT

Email: [email protected]

Marc Beirer, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Peter Biberthaler, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 26018526 (View on PubMed)

Other Identifiers

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Beiromat_02

Identifier Type: -

Identifier Source: org_study_id