NCT00590850

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
412

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
12.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

November 15, 2023

Status Verified

March 1, 2023

Enrollment Period

17.2 years

First QC Date

December 28, 2007

Last Update Submit

November 14, 2023

Conditions

High Energy Midshaft Clavicle Fractures

Outcome Measures

Primary Outcomes (1)

  • Disability of Arm, Shoulder and Hand (DASH) scores

    Disability of Arm, Shoulder and Hand (DASH) scores

    1 year

Secondary Outcomes (1)

  • Reoperation rate

    1 year

Study Arms (3)

Closed

NO INTERVENTION

Closed Treatment

ORIF

ACTIVE COMPARATOR

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

Procedure: ORIF with Plate and Screws

Pin

ACTIVE COMPARATOR

Pin Fixation

Procedure: Pin Fixation

Interventions

ORIF with Plate and ScrewsPROCEDURE

ORIF with plate and screws

ORIF
Pin FixationPROCEDURE

Clavicle fixation with clavicle pin

Pin

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prisma Health

Greenville, South Carolina, 29605, United States

Location

Related Publications (1)

  • Jeray KJ, Broderick JS, Mullis BH, Everhart J, Tanner SL, Snider BG; Southeastern Fracture Consortium. Multicenter, Prospective, Observational Study of Nonoperative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures. J Orthop Trauma. 2024 Jul 1;38(7):345-350. doi: 10.1097/BOT.0000000000002817.

    PMID: 38837208DERIVED

MeSH Terms

Interventions

Bone Plates

Intervention Hierarchy (Ancestors)

Internal FixatorsProstheses and ImplantsEquipment and SuppliesOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentSurgical Fixation Devices

Study Officials

  • Kyle J Jeray, MD

    Greenville Hospital System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2007

First Posted

January 11, 2008

Study Start

October 1, 2003

Primary Completion

December 1, 2020

Study Completion

October 1, 2023

Last Updated

November 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)