Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT06050473
Study type Interventional
Source HealthPartners Institute
Contact
Status Completed
Phase N/A
Start date November 2, 2016
Completion date August 10, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT03094481 - Interscalene vs. Superficial Cervical Block vs. Combination for Analgesia After Clavicle Fracture N/A
Recruiting NCT04161534 - KT Tape for Pediatric Clavicle Fractures N/A
Not yet recruiting NCT05579873 - Double Plating Versus Single Plating Techniques in Midshaft Clavicle Fractures
Not yet recruiting NCT05262998 - Intramedullary Screw Versus Plate in Displaced Midshaft Clavicle Fractures N/A
Completed NCT02769117 - Bone Ultrasound to Access Fracture Healing N/A
Withdrawn NCT04986553 - A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of Clavicle Plates
Recruiting NCT05810129 - Crossed Education in Relation to Muscle Mass in Patients Operated of Clavicular Fracture N/A
Enrolling by invitation NCT05327959 - A.L.P.S. Clavicle Plating System PMCF N/A
Recruiting NCT05867355 - Surgically Treated Displaced Mid-diaphyseal Clavicle Fractures
Completed NCT00872105 - Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle N/A
Withdrawn NCT00849771 - Operative Versus Nonoperative Treatment for Scapula Fractures N/A
Completed NCT05268874 - The Effectiveness of Clavipectoral Fascia Plane Block for Clavicle Surgery N/A
Recruiting NCT04250415 - Multi-Center Adolescent Clavicle Fracture Trial: Operative vs. Non-Operative Treatment
Withdrawn NCT01133769 - Operative Versus Non-Operative Treatment of Clavicle Fracture in PolyTrauma N/A
Completed NCT06269562 - SPSIPB and CPB on Clavicle Surgeries N/A
Completed NCT01405703 - Percutaneous Versus Open Plate Fixation of Diaphyseal Clavicle Fractures N/A
Completed NCT01410032 - Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures Phase 2
Suspended NCT05454306 - Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures N/A
Completed NCT03402269 - Treatment of Pediatric Mid-shaft Clavicle Fractures: A Prospective, Observational Study
Active, not recruiting NCT04622137 - Kinesiotaping Therapy for Clavicular Fractures FRACTURES: N/A