Clinical trial NCT06050473: Supraclavicular Nerve During Clavicle ORIF
Official title: Preservation vs Sacrifice of the Supraclavicular Nerve During Clavicle ORIF: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clavicle Fracture
Keywords: Clavicle
Fracture
Supraclavicular nerve
Post-operative
Paresthesia
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 45
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Paresthesia mapping
timeFrame: Each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative
Secondary outcomes:
measure: Cutaneous Hyperesthesia/dysesthesia mapping
timeFrame: Each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative
measure: Patient Morbidity
timeFrame: 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
measure: 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).
timeFrame: 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
Other outcomes:
Locations:
Study officials:
affiliation: HealthPartners Institute
name: Peter A Cole, MD
role: PRINCIPAL_INVESTIGATOR
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