Supraclavicular Nerve During Clavicle ORIF

September 21, 2023 updated by: HealthPartners Institute

Preservation vs Sacrifice of the Supraclavicular Nerve During Clavicle ORIF: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, partially-blinded, single center, randomized controlled trial to compare the post-operative outcomes of paresthesias and morbidity between nerve-preserving and nerve-sacrificing procedures after surgical fixation of clavicle fractures. Although prior studies explore different incision orientation, most fail to specify whether or not the supraclavicular nerve branches were identified and protected and also lack a patient questionnaire that focuses on paresthesia characteristics and patient quality of life as it relates to the measured area of postoperative numbness. In this proposed study, the investigators will be able to fill this gap in knowledge and give insight into whether or not a nerve-sparing technique should be used to decrease the morbidity of postoperative chest wall paresthesia following operative fixation of clavicle fractures. This research will be important to the scientific community because it will help guide a physician's pre-operative counseling and establish realistic expectations for their patients. It could also guide a physician's surgical technique in a manner to decrease post-operative morbidity for patient's undergoing surgical fixation of clavicle fractures.

  1. Group 1 - Operative treatment utilizing a supraclavicular nerve-sacrificing procedure
  2. Group 2 - Operative treatment utilizing a supraclavicular nerve-preserving procedure

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients >17 years old with a displaced, midshaft clavicle fracture
  • Closed injury
  • No skin compromise

Exclusion Criteria:

  • Clavicle non-union/malunion
  • Far proximal (medial) or far distal (lateral) clavicle fractures
  • Open injury
  • Skin compromise
  • Prior surgery of the anterior chest wall or affected clavicle
  • Pre-existing chest wall numbness, cervical root symptoms, neurologic or sensory deficits, signs of neuropathy
  • We will not exclude patients on membrane stabilizing medications for nerve paresthesia (GABA agonists, tricyclic anti-depressants) but will include this on patient intake form and document it
  • Traumatic brain injury
  • Patients who had prior deltopectoral approach to glenoid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Supraclavicular nerve-sacrificing procedure
Surgeon will not attempt to identify the supraclavicular nerve branches.
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.
Active Comparator: Supraclavicular nerve-preserving procedure
Surgeon will attempt to dissect out, identify and preserve all branches of the supraclavicular nerve throughout the fracture reduction, fixation and closure.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Paresthesia mapping
Time Frame: Each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative
A trained research fellow will be blinded to the operative intervention performed and will measure the area of chest wall paresthesia using a transparency grid made up of 1cmx1cm squares. The transparency grid will be placed over the patient's clavicle and the patient will be instructed to palpate the chest wall for areas of paresthesia. The examiner will then outline the area of paresthesia by tracing it onto the transparency slide.
Each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cutaneous Hyperesthesia/dysesthesia mapping
Time Frame: Each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative
A 10 gram Semmes-Weinstein monofilament will be applied twice, for 1 second at each point as indicated on the diagram in Appendix E. It will be applied to two points at the medial 1/3, middle 1/3 and lateral 1/3 of the subclavicular region, 3cm distal the inferior border of the clavicle at each point. The monofilament will be applied twice for 1 second at each point. Unperceived points will be identified and recorded based on location at medial, middle or lateral 1/3. If this monofilament test results in dysesthesia (pain, tingling, shock like sensations), this will be recorded similarly.
Each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative
Patient Morbidity
Time Frame: Prior to measuring the area of paresthesia each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative
The research fellow will administer the Patient Morbidity questionnaire and record the patient's responses. This outlines the characteristics of the paresthesia and the effect on the patient. This will be the investigator's measure of patient-reported morbidity.
Prior to measuring the area of paresthesia each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative
Disabilities of the Arm, Shoulder and Hand (DASH); A 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability).
Time Frame: Prior to measuring the area of paresthesia each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative
The patient will fill out the Disability of Arm, Shoulder & Hand questionnaire as a measure of functional outcome.
Prior to measuring the area of paresthesia each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Investigators

  • Principal Investigator: Peter A Cole, MD, HealthPartners Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2016

Primary Completion (Actual)

August 10, 2023

Study Completion (Actual)

August 10, 2023

Study Registration Dates

First Submitted

September 14, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 22, 2023

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A16-535

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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