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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00590850

Enrollment

412

Registered

2008-01-11

Start date

2003-10-31

Completion date

2023-10-31

Last updated

2023-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Energy Midshaft Clavicle Fractures

Brief 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).

Interventions

PROCEDUREORIF with Plate and Screws

ORIF with plate and screws

PROCEDUREPin Fixation

Clavicle fixation with clavicle pin

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Reoperation rate	1 year	rate of reoperations between groups

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026