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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

412 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2023-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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High Energy Midshaft Clavicle Fractures

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Closed

Closed Treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

ORIF

Open Reduction and Internal Fixation (ORIF) with Plate and Screws

Group Type ACTIVE_COMPARATOR

ORIF with Plate and Screws

Intervention Type PROCEDURE

ORIF with plate and screws

Pin

Pin Fixation

Group Type ACTIVE_COMPARATOR

Pin Fixation

Intervention Type PROCEDURE

Clavicle fixation with clavicle pin

Interventions

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ORIF with Plate and Screws

ORIF with plate and screws

Intervention Type PROCEDURE

Pin Fixation

Clavicle fixation with clavicle pin

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No