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Operative Versus Non-Operative Treatment of Clavicle Fracture in PolyTrauma

This study has been withdrawn prior to enrollment.
(Institutional issues Institution issues)
Sponsor:
Collaborator:
Synthes Inc.
Information provided by (Responsible Party):
Anna Rockich, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01133769
First received: May 27, 2010
Last updated: May 9, 2012
Last verified: May 2012
  Purpose

About 90% of chest injuries in America are due to blunt forces, mostly as a result of motor vehicle collisions and falls. Severity varies from minor bruising to severe chest injuries. For several years, clavicle ("collarbone") fractures have been treated without surgery (non-operatively), even when the fracture is out of place (displaced). Over the last few years, however, treatment has changed more towards surgical fixation (operative), because of the sometimes difficult healing in clavicle fractures that are displaced. Several research studies have shown that cases in which the clavicle fracture never heals completely (non-union) are more frequent after nonoperative treatment, compared to operative fixation. In those cases, surgery is still required, only later (secondary surgery). Further, clavicle malunion, in which the fracture heals but is still out of place) has been shown to be high after nonoperative treatment. Recent published research studies have shown better function, higher patient satisfaction, earlier return to activity (use of the arm) and decreased nonunion and malunion following surgery, also called open reduction/internal fixation. Despite recent published research, there is still a lack of agreement on when surgical fixation should be performed for clavicle fractures.

Patients with chest injuries often have clavicle fractures. Chest injuries can restrict patients' ability to breathe, cough, stand, walk and leave the hospital. Although it is unusual that chest injuries can be improved with surgery, patients with clavicle fractures and chest injuries might recover faster if the clavicle fractures were repaired.

Patients are being asked to take part in the study they have sustained a clavicle fracture associated with a chest injury with or without any other injury to the abdomen, or arms or legs. The aim of this study is to determine the difference in the hospital length of stay, intensive care unit length of stay, respiratory rehabilitation (recovery of good respiratory function), functional outcome, ability to become mobile again, complications and risk of dying in trauma patients with chest injury and clavicle fracture treated operatively versus non-operatively.


Condition
Clavicle Fracture
Chest Injury

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Operative Versus Non-Operative Treatment For Clavicle Fracture in the PolyTrauma Patient With Associated Chest Injury. A Prospective, Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Enrollment: 0
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Surgical vs Non surgical
This is an open, prospective, randomized, dual arm, parallel group clinical study of open reduction and internal fixation (ORIF) or intramedullary nail (IMN) versus non operative treatment for clavicle fracture in polytrauma patients with associated chest injury, with or without additional injuries to the head, abdomen, pelvis and extremities.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who present with a unilateral clavicle fractures which are >2cm displaced, >2cm shortened, significantly comminuted, or are tenting the skin or which are bilateral and with associated chest injury and with or without additional injuries to the abdomen, pelvis or extremities will be approached for the study.

Criteria

Inclusion Criteria:

  1. Patients males and females of any race.
  2. Patients between ages 18 and 80
  3. Patients who present with a unilateral clavicle fractures which are >2cm displaced, >2cm shortened, significantly comminuted, or are tenting the skin or which are bilateral and with associated chest injury and with or without additional injuries to the abdomen, pelvis or extremities will be approached for the study.

Exclusion Criteria:

  1. Severe brain injury (GCS less than or equal to 13)
  2. Intubated patients
  3. Injury precluding operative fixation within 7 days of admission
  4. Open clavicle fracture
  5. Spinal cord injuries
  6. Age <18 or greater than or equal to 80
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133769

Locations
United States, Colorado
St. Anthony's Hospitals Centura Health
Denver, Colorado, United States, 80204
Sponsors and Collaborators
University of Kentucky
Synthes Inc.
Investigators
Principal Investigator: Edmund Rowland, M.D. St. Anthony's Hospitals/Panorama Orthopedics and Spine Center
  More Information

No publications provided

Responsible Party: Anna Rockich, Director, General Surgery Clinical Research Program, University of Kentucky
ClinicalTrials.gov Identifier: NCT01133769     History of Changes
Other Study ID Numbers: SAH 1198
Study First Received: May 27, 2010
Last Updated: May 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kentucky:
Clavicle fracture
fixation
polytrauma
Clavicle fracture patients with chest injury

Additional relevant MeSH terms:
Fractures, Bone
Multiple Trauma
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014