NCT01078480

Brief Summary

This study will compare non-operative treatment of displaced midshaft collarbone fractures with operative treatment using a precontoured titanium plate and screws. The study hypothesis is that operation will provide better pain relief, faster return to activities, better function of the involved upper limb, and lower the risk of a non healing fracture (non union).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 2, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 22, 2016

Status Verified

January 1, 2016

Enrollment Period

5.7 years

First QC Date

February 27, 2010

Last Update Submit

January 21, 2016

Conditions

Displaced Midshaft Fracture of the Collar Bone

Keywords

FractureCollar bone

Outcome Measures

Primary Outcomes (1)

  • Disabilities of the Arm, Shoulder and Hand (DASH) Score

    The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. The tool gives clinicians and researchers the advantage of having a single, reliable instrument that can be used to assess any or all joints in the upper extremity.

    6 weeks, 3 months, 6 months, 1 year

Secondary Outcomes (1)

  • Constant-Murley Score

    6 weeks, 3 months, 6 months, 1 year

Study Arms (2)

Arm sling treatment

EXPERIMENTAL

Displaced midshaft fracture of the collar bone treated with an arm sling

Procedure: Displaced midshaft fracture of the collar bone

Operation

EXPERIMENTAL

Displaced midshaft fracture of the collar bone treated with operation using a pre contoured titanium plate and screws.

Procedure: Operation using a precontoured titanium plate and screws

Interventions

Operation using a precontoured titanium plate and screwsPROCEDURE

Operation using a precontoured titanium plate and screws

Also known as: No other names.
Operation
Displaced midshaft fracture of the collar bonePROCEDURE

Displaced midshaft fracture of the collar bone treated with an arm sling

Also known as: No other names.
Arm sling treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • fracture located to the mid third of the collar bone where there is no contact between the fractured surface of the main fragments on x-ray in one or two of two levels.

You may not qualify if:

  • bilateral fracture
  • imminent skin perforation
  • open fracture
  • associated neurovascular effect
  • unstable fracture of neck of scapula "floating shoulder"
  • fracture of coincidental upper extremity distal for the shoulder
  • pathologic fracture
  • the patient states that there was a unilateral or bilateral shoulder problem before the fracture
  • fracture realized more than 14 days after it arose
  • circumstances which make it impossible to carry out one of the two regimes, i.e. mental illness and abuse
  • circumstances which make follow-up impossible, i.e. address far from the including departments and stays abroad of long duration
  • medical contraindication against surgery or general anaesthesia
  • former participation in the trial
  • former fracture contra/ipsilateral at the age of 15 or older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orthopaedic Division, Randers Hospital

Randers, Central Jutland, 8930, Denmark

Location

Related Publications (1)

  • Qvist AH, Vaesel MT, Jensen CM, Jakobsen T, Jensen SL. Minimal Pain Decrease Between 2 and 4 Weeks After Nonoperative Management of a Displaced Midshaft Clavicle Fracture Is Associated with a High Risk of Symptomatic Nonunion. Clin Orthop Relat Res. 2021 Jan 1;479(1):129-138. doi: 10.1097/CORR.0000000000001411.

    PMID: 32675585DERIVED

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Carsten M Jensen, M.D.Sci.

    Orthopaedic Division, Central Jutland, Randers Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2010

First Posted

March 2, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 22, 2016

Record last verified: 2016-01

Locations

DK(1)