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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: Completed NA study of High Energy Midshaft Clavicle Fractures, sponsored by Prisma Health-Upstate.
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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Disability of Arm, Shoulder and Hand (DASH) scores
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 |
What the finished NCT00590850 record still lists
NCT00590850 is an interventional study that assigns participants to a tested intervention. The registered 412 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (71% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00590850's enrollment target sits among peer trials
412 241st of 2000 higher than 1,759 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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