Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06050473
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2023-09-14
Brief Title:
Supraclavicular Nerve During Clavicle ORIF
Sponsor:
HealthPartners Institute
Organization:
HealthPartners Institute
Study Overview
Official Title:
Preservation vs Sacrifice of the Supraclavicular Nerve During Clavicle ORIF A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Clavicle fractures are a common orthopedic injury and make up 26-5 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 physicians pre-operative counseling and establish realistic expectations for their patients It could also guide a physicians surgical technique in a manner to decrease post-operative morbidity for patients 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
1 Group 1 - Operative treatment utilizing a supraclavicular nerve-sacrificing procedure
2 Group 2 - Operative treatment utilizing a supraclavicular nerve-preserving procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None