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OpenTrials
Completed

NCT Number: NCT00590850

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).

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prisma Health

Greenville, South Carolina, 29605, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ORIF with Plate and Screws

Procedure

ORIF with plate and screws

Pin Fixation

Procedure

Clavicle fixation with clavicle pin

Primary outcomes

  1. Disability of Arm, Shoulder and Hand (DASH) scores

    Time frame: 1 year

    Disability of Arm, Shoulder and Hand (DASH) scores

Secondary outcomes

  1. Reoperation rate

    Time frame: 1 year

    rate of reoperations between groups

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Collaborators

  • Indiana University
  • Orthopaedic Trauma Association

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2020
Study completion
2023
First posted
Jan 11, 2008
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.