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Treatment of Displaced, Midshaft Clavicle Fractures. Sling or Plate?

NCT01483482 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-06-26

No results posted yet for this study

Summary

Clavicle fractures are frequent and represent somewhere between 5 and 10% of all fractures seen in orthopedics.

There is no consensus concerning the best treatment of acute, displaced, midshaft clavicle fractures. Conservative treatment has, traditionally, been the preferred treatment but recent studies have shown higher incidences of non-union and symptomatic malunion associated with conservative treatment. Primary surgery has in several studies been associated with high success rates and few complications but there is no compelling evidence towards superior results after primary surgery.

The objective of this randomized study is to compare conservative treatment (sling) with primary surgery (locking plate) of acute, displaced, midshaft clavicle fractures.

Conditions

  • Acute, Displaced Midshaft Clavicle Fractures

Interventions

PROCEDURE

Conservative Treatment

Simple Sling

PROCEDURE

Surgical treatment

Superior Locking plate

Sponsors & Collaborators

  • Hvidovre University Hospital

    lead OTHER

Principal Investigators

  • Ilija Ban, MD · University Hospital of Hvidovre

  • Anders Troelsen, MD, PhD · University Hospital of Hvidovre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2016-08-31
Completion
2016-09-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01483482 on ClinicalTrials.gov