NCT01199653

Brief Summary

The purpose of this study is to find whether to operate or treat conservatively dislocated midshaft clavicle fractures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2004

Longer than P75 for phase_2

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

Study Start

First participant enrolled

August 1, 2004

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
Last Updated

September 13, 2010

Status Verified

September 1, 2010

Enrollment Period

3.2 years

First QC Date

September 10, 2010

Last Update Submit

September 10, 2010

Conditions

ClavicleFracture

Keywords

clavicle fracturesmidshaftdislocatedoperative treatmentconservative treatmentnon-operative treatmentrandomized controlled trialbone plates

Outcome Measures

Primary Outcomes (3)

  • Shoulder function

    Shoulder Function is measured by Constant shoulder Score (CS) is a outcome measure for assessing the outcomes of the treatment of shoulder disorders.It inclues the pain score, functional assessment, range of motion and strength measures.

    Three months

  • Shoulder function

    Shoulder Function is measured by Constant shoulder Score (CS) is a outcome measure for assessing the outcomes of the treatment of shoulder disorders.It inclues the pain score, functional assessment, range of motion and strength measures.

    One year

  • Shoulder function

    Shoulder Function is measured by Constant shoulder Score (CS) is a outcome measure for assessing the outcomes of the treatment of shoulder disorders.It inclues the pain score, functional assessment, range of motion and strength measures.

    Two years

Secondary Outcomes (12)

  • Disability of the Arm, Shoulder and Hand (DASH)

    Three months

  • Pain at rest and activity

    Three weeks

  • Fracture healing

    Three months

  • Complications

    Continous till two years

  • Disability of the Arm, Shoulder and Hand (DASH)

    One year

  • +7 more secondary outcomes

Study Arms (2)

Non-operative treatment

ACTIVE COMPARATOR

Non-operative (conservative) treatment of the clavicle fracture

Procedure: Non-operative treatment with arm immobilised to a sling

Operative treatment

ACTIVE COMPARATOR

Operative stabilization (i.e. ORIF) of the fracture with a plate and screws.

Procedure: Operative treatment

Interventions

Operative treatmentPROCEDURE

Fracture stabilization with stainless steel reconstruction plate and screws. After the operation arm is immobilized to a sling for three weeks. Pendulum movements are allowed immediately.

Operative treatment
Non-operative treatment with arm immobilised to a slingPROCEDURE

Arm is immobilised to a sling for three weeks. Pendulum movements are allowed immediately.

Non-operative treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a completely displaced middle third clavicle fracture, no cortical contact between main fragments
  • fresh fracture, treatment within seven days after injury
  • age between 18 and 70 years
  • provided informed consent

You may not qualify if:

  • fracture was not dislocated
  • multiple injured patient
  • associated neurovascular injury, or suspicion of it
  • reduced cooperation
  • cancer or any severe illness impairing health
  • pathological fracture
  • treatment seven days after injury
  • open fracture
  • corticosteroid or immunosuppressive medication
  • upper extremity fracture at same time
  • an earlier clavicle or shoulder region fracture
  • pregnancy
  • lack of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital, Töölö Hospital

Helsinki, Uusimaa, 00260, Finland

Location

Related Publications (9)

  • Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaft clavicular fractures. A multicenter, randomized clinical trial. J Bone Joint Surg Am. 2007 Jan;89(1):1-10. doi: 10.2106/JBJS.F.00020.

    PMID: 17200303BACKGROUND

  • Hill JM, McGuire MH, Crosby LA. Closed treatment of displaced middle-third fractures of the clavicle gives poor results. J Bone Joint Surg Br. 1997 Jul;79(4):537-9. doi: 10.1302/0301-620x.79b4.7529.

    PMID: 9250733BACKGROUND

  • McKee MD, Seiler JG, Jupiter JB. The application of the limited contact dynamic compression plate in the upper extremity: an analysis of 114 consecutive cases. Injury. 1995 Dec;26(10):661-6. doi: 10.1016/0020-1383(95)00148-4.

    PMID: 8745801BACKGROUND

  • NEER CS 2nd. Nonunion of the clavicle. J Am Med Assoc. 1960 Mar 5;172:1006-11. doi: 10.1001/jama.1960.03020100014003. No abstract available.

    PMID: 14426324BACKGROUND

  • Nordqvist A, Petersson C. The incidence of fractures of the clavicle. Clin Orthop Relat Res. 1994 Mar;(300):127-32.

    PMID: 8131324BACKGROUND

  • Nowak J, Holgersson M, Larsson S. Can we predict long-term sequelae after fractures of the clavicle based on initial findings? A prospective study with nine to ten years of follow-up. J Shoulder Elbow Surg. 2004 Sep-Oct;13(5):479-86. doi: 10.1016/j.jse.2004.01.026.

    PMID: 15383801BACKGROUND

  • Nowak J, Mallmin H, Larsson S. The aetiology and epidemiology of clavicular fractures. A prospective study during a two-year period in Uppsala, Sweden. Injury. 2000 Jun;31(5):353-8. doi: 10.1016/s0020-1383(99)00312-5.

    PMID: 10775691BACKGROUND

  • Poigenfurst J, Rappold G, Fischer W. Plating of fresh clavicular fractures: results of 122 operations. Injury. 1992;23(4):237-41. doi: 10.1016/s0020-1383(05)80006-3.

    PMID: 1618563BACKGROUND

  • Zlowodzki M, Zelle BA, Cole PA, Jeray K, McKee MD; Evidence-Based Orthopaedic Trauma Working Group. Treatment of acute midshaft clavicle fractures: systematic review of 2144 fractures: on behalf of the Evidence-Based Orthopaedic Trauma Working Group. J Orthop Trauma. 2005 Aug;19(7):504-7. doi: 10.1097/01.bot.0000172287.44278.ef.

    PMID: 16056089BACKGROUND

MeSH Terms

Conditions

Fractures, BoneJoint Dislocations

Condition Hierarchy (Ancestors)

Wounds and InjuriesJoint DiseasesMusculoskeletal Diseases

Study Officials

  • Kaisa J Virtanen, MD

    Helsinki Uiversity Central Hospital

    PRINCIPAL INVESTIGATOR

  • Ville Remes, MD PhD

    Helsinki University Central Hospital

    STUDY CHAIR

  • Jarkko Pajarinen, MD PhD

    Helsinki University Central Hospital

    STUDY CHAIR

  • Vesa Savolainen, MD PhD

    Helsinki University Central Hospital

    STUDY CHAIR

  • Jan-Magnus Björkenheim, MD PhD

    Helsinki University Central Hospital

    STUDY CHAIR

  • Mika P Paavola, MD PhD

    Helsinki University Central Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2010

First Posted

September 13, 2010

Study Start

August 1, 2004

Primary Completion

October 1, 2007

Study Completion

November 1, 2009

Last Updated

September 13, 2010

Record last verified: 2010-09

Locations

FI(1)