Study Comparing Intramedullary Nailing, Plate Fixation, and Non-operative Treatment of Clavicle Fractures
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ClinicalTrials.gov Identifier: NCT01311219 |
Recruitment Status
:
Withdrawn
(PI left institution)
First Posted
: March 9, 2011
Last Update Posted
: September 30, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Clavicle Fractures | Other: Non-operative Treatment Procedure: Operative Treatment-Plate Fixation Procedure: Operative Treatment-Intramedullary Pinning | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Intramedullary Nailing, Plate Fixation, and Non-operative Treatment of Acute, Displaced, Midshaft Clavicle Fractures: a Prospective Randomized Trial |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | May 2009 |
Actual Study Completion Date : | May 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: No surgery
Non-operative Treatment
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Other: Non-operative Treatment
A figure-of-8 brace will be applied to afflicted extremity in clinic. The patient will be instructed on proper application of the brace and asked to continue wearing the brace for 2 to 6 weeks, depending on the patient's level of comfort.
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Active Comparator: Plate fixation
Operative Treatment-Plate fixation
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Procedure: Operative Treatment-Plate Fixation
Plate fixation of the clavicle fracture will be performed utilizing a 3.5-mm dynamic compression plate.
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Active Comparator: Intramedullary pinning
Operative Treatment-Intramedullary Pinning
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Procedure: Operative Treatment-Intramedullary Pinning
Clavicle fracture will be repaired through intramedullary pinning using The Rockwood Clavicle Pin (DePuy Orthopaedics, Warsaw, IN).
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- Disability of the Arm, Shoulder, and Hand (DASH) [ Time Frame: 2, 6, and 12 weeks and 6 and 12 months ]
- The Constant Pain Score [ Time Frame: 2, 6, and 12 weeks and 6 and 12 months ]

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Ages Eligible for Study: | 16 Years to 80 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria: All candidates with a radiographically confirmed, displaced, midshaft clavicle fracture, between the ages of 16 and 80.
Exclusion Criteria: Patients presenting with ipsilateral shoulder girdle injury, open fracture, pathologic fracture, or associated neurologic injury. Patients who are pregnant and therefore, unable to undergo radiologic assessment. Patients deemed incompetent to make medical decisions regarding their own health care. Patients unwilling or unable to complete postoperative evaluation at 2, 6, and 12 weeks and long term follow-up evaluation at 6 and 12 months. Prisoners who will be difficult to complete follow-up.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01311219
United States, Missouri | |
University of Missouri-Columbia | |
Columbia, Missouri, United States, 65212 |
Principal Investigator: | Richard A White, M.D. | University of Missouri-Columbia |
Publications:
Responsible Party: | University of Missouri-Columbia |
ClinicalTrials.gov Identifier: | NCT01311219 History of Changes |
Obsolete Identifiers: | NCT01307670 |
Other Study ID Numbers: |
1109438-1 |
First Posted: | March 9, 2011 Key Record Dates |
Last Update Posted: | September 30, 2016 |
Last Verified: | September 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Additional relevant MeSH terms:
Fractures, Bone Wounds and Injuries |