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

November 14, 2023 updated by: Prisma Health-Upstate

A Multicenter, Prospective, Randomized Trial of Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

412

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ages of 18 and 85
  • a midshaft clavicle fracture
  • fracture displaced the width of the clavicle or shortened at least 1.5 cm
  • less than 21 days since the injury

Exclusion Criteria:

  • injury involving the lateral ligaments
  • fracture involve the sternoclavicular joint
  • Pathologic Fracture
  • Open Fracture
  • Fracture with neurovascular compromise
  • Displaced fracture with impending skin compromise
  • Medical comorbidities that preclude surgery
  • Associated injuries to ipsilateral shoulder girdle
  • severe cognitive disability or injury that may inhibit study form completion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Closed
Closed Treatment
Active Comparator: ORIF
Open Reduction and Internal Fixation (ORIF) with Plate and Screws
Procedure: ORIF with Plate and Screws
ORIF with plate and screws
Active Comparator: Pin
Pin Fixation
Procedure: Pin Fixation
Clavicle fixation with clavicle pin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability of Arm, Shoulder and Hand (DASH) scores
Time Frame: 1 year
Disability of Arm, Shoulder and Hand (DASH) scores
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperation rate
Time Frame: 1 year
rate of reoperations between groups
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prisma Health-Upstate

Collaborators

Indiana University
Orthopaedic Trauma Association

Investigators

  • Principal Investigator: Kyle J Jeray, MD, Greenville Hospital System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

December 1, 2020

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

December 28, 2007

First Submitted That Met QC Criteria

December 28, 2007

First Posted (Estimated)

January 11, 2008

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GHS-07-03-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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