Clinical Trials Logo
  1. Home
  2. Clavicle Fracture
  3. NCT04250415

Multi-Center Adolescent Clavicle Fracture Trial: Operative vs. Non-Operative Treatment — FACTS  

Clavicle Fracture Clinical Trial

Official title:
Prospective, Multi-Center Adolescent Clavicle Fracture Registry

Clinical Trial Summary

Investigators from eight tertiary care, level 1 pediatric trauma centers have developed a protocol for the establishment of a formal, prospective multi-center adolescent clavicle registry, with designs for standardized radiographic assessment and the prospective collection of validated outcome measures and complications data, for all patients, ages 10-18, treated for clavicle shaft fractures, operatively and non-operatively. Eventually, the investigators would like to do comparative analysis for the operative and non-operative treatment arms, with additional sub-stratified analyses performed within these treatment arms by age and activity level. Among the primary goals of research projects stemming from the first arm of this registry, FACTS A, is to explore the hypothesis that non-operative treatment is associated with lower costs, greater safety, and equivalent or superior outcomes, compared with operative treatment, despite a national trend towards increasing surgical treatment. The second arm of the registry, FACTS B, will continue to investigate the same hypotheses, excluding cost outcomes, in patients only with completely displaced midshaft clavicle fractures.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04250415
Study type Observational [Patient Registry]
Source Boston Children's Hospital
Contact Lauren Hutchinson, MPH
Email Lauren.Hutchinson@childrens.harvard.edu
Status Recruiting
Phase
Start date March 11, 2013
Completion date June 1, 2026
View Details
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
Completed NCT06050473 - Supraclavicular Nerve During Clavicle ORIF 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Withdrawn NCT04986553 - A Multi-Center, Prospective Registry to Evaluate the Continued Safety and Performance of Clavicle Plates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
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