Supraclavicular Nerve During Clavicle ORIF

Not Applicable

Completed

• Conditions: Clavicle Fracture
• Interventions: Procedure: Nerve preserving procedure; Procedure: Nerve-sacrificing procedure

• Registration Number: NCT06050473
• Lead Sponsor: HealthPartners Institute

Brief 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.

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 Timeline

• Study Start: 2016-11-02
• Primary Completion: 2023-08-10
• Study Completion: 2023-08-10
• Status Verified: 2023-09
• Study First Submitted: 2023-09-14
• Study First Submitted QC: 2023-09-21
• Last Update Submitted: 2023-09-21
• Study First Posted: 2023-09-22
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supraclavicular nerve-preserving procedure	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.
Supraclavicular nerve-sacrificing procedure	Nerve-sacrificing procedure	Surgeon will not attempt to identify the supraclavicular nerve branches.

Primary Outcome Measures

Name	Time	Method
Paresthesia mapping	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.

Secondary Outcome Measures

Name	Time	Method
Patient 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	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.
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).	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.
Cutaneous Hyperesthesia/dysesthesia mapping	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.