Operative Versus Non-Operative Treatment of Clavicle Fracture in PolyTrauma

Operative Versus Non-Operative Treatment For Clavicle Fracture in the PolyTrauma Patient With Associated Chest Injury. A Prospective, Randomized Clinical Trial

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01133769

Enrollment

Registered

2010-05-31

Start date

2010-06-30

Completion date

2013-06-30

Last updated

2017-01-20

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

Conditions

Chest Injury, Clavicle Fracture

Keywords

Clavicle fracture, fixation, polytrauma, Clavicle fracture patients with chest injury

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

Healthy volunteers

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

Countries

United States

Outcome results