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NCT00590850 · ClinicalTrials.gov registry record · NA
Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures
A NA study of High Energy Midshaft Clavicle Fractures, sponsored by Prisma Health-Upstate.
- Completed
- Registry status
- NA
- Development phase
- 412
- Enrollment target
- 1
- Study location
NCT00590850 is a NA study of High Energy Midshaft Clavicle Fractures that has completed, run by Prisma Health-Upstate. The registered enrollment target is 412 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00590850, a NA study of High Energy Midshaft Clavicle Fractures, has completed, sponsored by Prisma Health-Upstate.
- COMPLETED
- Registry status
- NA
- Development phase
- 412 participants
- Enrollment target
- 1
- Study location
Study 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).
Conditions Studied
Interventions
- PROCEDURE ORIF with Plate and Screws
- PROCEDURE Pin Fixation
Study Locations (1)
South Carolina
- Prisma Health - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 412 participants |
| Start Date | 2003-10 |
| Est. Completion | 2023-10 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00590850
The ClinicalTrials.gov registry entry for NCT00590850 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 412 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prisma Health-Upstate, which has 67 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with High Energy Midshaft Clavicle Fractures appearing as the primary indexed condition, and to 2 interventions - of which ORIF with Plate and Screws is the first listed.
NCT00590850 reports 1 study location spanning 1 distinct geographic area - top geographies include South Carolina.
Frequently Asked Questions
What is clinical trial NCT00590850 about?
NCT00590850 is a clinical study titled "Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures". 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 reas...
What is the current status of trial NCT00590850?
This trial is currently completed. It is a NA study. The enrollment target is 412 participants. The study started on 2003-10. Estimated completion is 2023-10.
What conditions does trial NCT00590850 study?
This clinical trial studies the following conditions: High Energy Midshaft Clavicle Fractures.
What interventions are being tested in trial NCT00590850?
The interventions under investigation include: ORIF with Plate and Screws (PROCEDURE), Pin Fixation (PROCEDURE).
Who is sponsoring clinical trial NCT00590850?
This trial is sponsored by Prisma Health-Upstate, which has 67 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00590850 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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