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Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures

NCT00590850 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 412

Last updated 2023-11-15

No results posted yet for this study

Summary

Clavicle (collar bone) fractures account for about 33% of all fractures around the shoulder. Some surgeons suggest that surgical treatment is the best option, while others suggest that nonoperative care is the best treatment. There is no evidence to date that either option in superior. For this reason, we propose to conduct a prospective, randomized clinical trial of surgical versus non-surgical treatment of displaced high-energy clavicle fractures. This study will use both objective clinical and patient-based outcome measures. The purpose of this study is to see if there is a difference between clinical outcomes (healing rate, time to healing, time to return to work, Constant Score, complications), functional outcomes (DASH Score), and health related quality of life (SF-36) in nonoperative care and two types of surgical care for displaced fractures of the clavicular shaft in adults.

Included patients will be randomized into one of three groups: nonoperative care (Group N); surgical care using plates and screws (Group P); and surgical care using intramedullary pin put inside of the clavicle to stabilize it (Group I).

Conditions

  • High Energy Midshaft Clavicle Fractures

Interventions

PROCEDURE

ORIF with Plate and Screws

ORIF with plate and screws

PROCEDURE

Pin Fixation

Clavicle fixation with clavicle pin

Sponsors & Collaborators

  • Orthopaedic Trauma Association

    collaborator OTHER

  • Indiana University

    collaborator OTHER

  • Prisma Health-Upstate

    lead OTHER

Principal Investigators

  • Kyle J Jeray, MD · Greenville Hospital System

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2020-12-31
Completion
2023-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00590850 on ClinicalTrials.gov