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Surgical Innovations in Treatment of Clavicle Fractures (ClavFrac)

T

Technical University of Munich

Status

Unknown

Conditions

Complication

Treatments

Procedure: conventional plate osteosynthesis
Procedure: mini-incision-type osteosynthesis

Study type

Interventional

Funder types

Other

Identifiers

NCT02247778
Beiromat_02

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

conventional plate osteosynthesis
Active Comparator group
Description:
Standard procedure
Treatment:
Procedure: conventional plate osteosynthesis
mini-incision-type osteosynthesis
Active Comparator group
Description:
mini-incision
Treatment:
Procedure: mini-incision-type osteosynthesis

Trial contacts and locations

1

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Central trial contact

Marc Beirer, MD; Chlodwig Kirchhoff, MD

Data sourced from clinicaltrials.gov

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