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NCT00849771 Clinical Trial

Operative Versus Nonoperative Treatment for Scapula Fractures

Clavicle Fracture Clinical Trial

Official title:
Multicenter Prospective Study of Operative and Non-operative Treatment for Scapula Fractures

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00849771
Other study ID # 080160
Secondary ID
Status Withdrawn
Phase N/A
First received February 20, 2009
Last updated November 10, 2015
Start date March 2008
Est. completion date January 2009

Study information
Verified date November 2015
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to contrast and evaluate the functional outcome of patients with operative vs. nonoperative treatment of scapula fractures. The specific aim of this project is to monitor the return to function of patients in both the operative and nonoperative cohorts.

The potential impact is a clearer set of choices in treatment options for this type of injury.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date January 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 Years of Age or Older

- Displacement of glenoid neck and scapula body of greater than 2 cm

- Angular deformity between the fracture fragments of greater than 45 degrees.

- A combination of displacement greater than 1.5 cm AND angulation greater than 30 degrees

- A glenopolar angle less than 22 degrees

- A Double Lesion of the Superior Shoulder Suspensory Complex (SSSC)

Exclusion Criteria:

- Age Less Than 18 years Old

- Brachial Plexus Injury

- Traumatic Brain Injury or Cognitive Disability preventing participation in the consent or post injury rehabilitation

- Spinal cord injuries resulting in paraplegic, quadriplegic disabilities or permanent ipsilateral peripheral nerve damage

- Ipsilateral Upper Extremity Injury

- Previous Shoulder Surgery

- Insufficient English proficiency to complete the DASH Questionnaire

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Vanderbilt Orthopaedic Institute, Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

See also
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