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COMPLETED NA

Non-Operative Versus Operative Treatment for High-Energy Midshaft Clavicle Fractures

NCT00590850 · View on ClinicalTrials.gov ↗

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).

Interventions

  • PROCEDURE ORIF with Plate and Screws
  • PROCEDURE Pin Fixation

Study Locations (1)

South Carolina

  • Prisma Health — Greenville

Trial Details

FieldValue
Enrollment Target 412 participants
Start Date 2003-10
Est. Completion 2023-10
Phase NA

Sponsor

Prisma Health-Upstate

19 total trials

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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 19 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00590850 reports 1 study location spanning 1 distinct geographic area — top geographies include South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00590850?

The interventions under investigation include: ORIF with Plate and Screws (PROCEDURE), Pin Fixation (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00590850?

This trial is sponsored by Prisma Health-Upstate, which has 19 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial