NCT01483482

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

June 26, 2019

Status Verified

June 1, 2019

Enrollment Period

5.3 years

First QC Date

November 29, 2011

Last Update Submit

June 24, 2019

Conditions

Acute, Displaced Midshaft Clavicle Fractures

Keywords

clavicle fracturesmidshaft clavicle fracturesconservative treatmentsurgical treatmentfunctional outcomeclinical assessmentadults

Outcome Measures

Primary Outcomes (1)

  • Functional outcome

    Constant score and DASH score is used to evaluate the functional score at 6 weeks, 6 months and 12 months.

    12 month follow-up

Secondary Outcomes (1)

  • Clinical assessment

    12 month follow-up

Study Arms (2)

Conservative treatment

OTHER

The group allocated to conservative treatment is treated with a simple sling. The sling is removed when the patient is pain free. The first 6 weeks max 1 kg of weight-bearing is allowed and the patient is instructed to restrict movement of the arm to the level of the shoulder.

Procedure: Conservative Treatment

Surgical treatment

OTHER

Patients allocated to surgical treatment are operated with a superior locking plate. The first 6 weeks max 1 kg of weight-bearing is allowed and the patient is instructed to restrict movement of the arm to the level of the shoulder.

Procedure: Surgical treatment

Interventions

Conservative TreatmentPROCEDURE

Simple Sling

Conservative treatment
Surgical treatmentPROCEDURE

Superior Locking plate

Surgical treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65 years
  • The patient can not have any medical untreated illness : only ASA 1-2
  • The patient must be able to speak and understand Danish.
  • The patient must be able to give informed consent.
  • The patient is expected to be able to follow the postoperative controls.

You may not qualify if:

  • Multitrauma patient
  • Other simultaneous fractures
  • Former surgery of the shoulder or clavicular.
  • Former chronic illness of the shoulder
  • Pathological or open fractures
  • Associated nerve or vessel damage of the affected arm.
  • Fractures older than 3 weeks (21 days)
  • Patients with drug(alcohol abuse where it is not expected that the patient i able to complete the follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Hvidovre

Hvidovre, 2650, Denmark

Location

MeSH Terms

Interventions

Conservative TreatmentSurgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Ilija Ban, MD

    University Hospital of Hvidovre

    PRINCIPAL INVESTIGATOR

  • Anders Troelsen, MD, PhD

    University Hospital of Hvidovre

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD

Study Record Dates

First Submitted

November 29, 2011

First Posted

December 1, 2011

Study Start

April 1, 2011

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

June 26, 2019

Record last verified: 2019-06

Locations

DK(1)