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Supraclavicular Nerve During Clavicle ORIF

NCT06050473 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-09-22

No results posted yet for this study

Summary

Clavicle fractures are a common orthopedic injury and make up 2.6%-5% of all fractures. Despite the benefits of operative management, post-operative chest wall paresthesia is a well-known complication among surgeons and is well described in the literature. Studies reporting on the natural history of post-operative paresthesia report an incidence of chest wall numbness anywhere from 10-80% and this is attributed to iatrogenic injury of the branches of the supraclavicular nerve that provide sensation over the clavicle, anteromedial shoulder and proximal chest. While this may seem like an easy complication to avoid, anatomic studies give insight into the complex and unpredictable branching of the supraclavicular nerve. The aim of this study was to compare the area (cm2) and change in size over time of post-operative paresthesia (includes hypesthesia and dysesthesia) following ORIF of displaced clavicle fractures between nerve-sacrificing and nerve-preserving procedures.

Conditions

  • Clavicle Fracture

Interventions

PROCEDURE

Nerve-sacrificing procedure

Surgical fixation of the clavicle fracture will be performed through a horizontal incision over the clavicle. During the incision and soft tissue dissection, the surgeon will not attempt to identify the supraclavicular nerve branches. Instead, the surgeon will cut the nerve branches during the dissection.

PROCEDURE

Nerve preserving procedure

Surgical fixation of the clavicle fracture will be performed through the same horizontal incision over the clavicle. The surgeon will attempt to dissect out, identify and preserve all branches of the supraclavicular nerve throughout the fracture reduction, fixation and closure.

Sponsors & Collaborators

  • HealthPartners Institute

    lead OTHER

Principal Investigators

  • Peter A Cole, MD · HealthPartners Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-02
Primary Completion
2023-08-10
Completion
2023-08-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06050473 on ClinicalTrials.gov