Clinical trial NCT01199653: Study Comparing Plate Stabilization to Conservative Treatment in Midshaft Clavicle Fractures
Official title: Nonoperative Versus Operative Treatment of Midshaft Clavicle Fractures - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Clavicle
Fracture
Keywords: clavicle fractures
midshaft
dislocated
operative treatment
conservative treatment
non-operative treatment
randomized controlled trial
bone plates
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2010-09-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Midshaft clavicle fractures are common comprising 2% of all fractures and 35% to 45% of all shoulder girdle injuries in adults. Old-established treatment practices, based on no randomised controlled trials, are used for clavicle fractures. By tradition, midshaft clavicle fractures have been treated conservatively with arm immobilized to a sling for few weeks. The goal of treatment is to restore painless function of the upper extremity.

There have been some recommendations for operative treatment, such as skin compromising in fracture area, open fracture, floating shoulder, neurovascular symptoms in upper extremity, or multiple injuries. Recently, increasing interest has emerged in the surgical treatment.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Shoulder function
timeFrame: Three months
measure: Shoulder function
timeFrame: One year
measure: Shoulder function
timeFrame: Two years
Secondary outcomes:
measure: Disability of the Arm, Shoulder and Hand (DASH)
timeFrame: Three months
measure: Pain at rest and activity
timeFrame: Three weeks
measure: Fracture healing
timeFrame: Three months
measure: Complications
timeFrame: Continous till two years
measure: Disability of the Arm, Shoulder and Hand (DASH)
timeFrame: One year
measure: Disabilities of the Arm, Shoulder and Hand (DASH)
timeFrame: Two years
measure: Pain at rest and activity
timeFrame: Six weeks
measure: Pain at rest and at activity
timeFrame: Three months
measure: Pain at rest and at activity
timeFrame: One year
measure: Pain at rest and at activity
timeFrame: Two years
measure: Fracture healing
timeFrame: One year
measure: Fracture healing
timeFrame: Two years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital, Töölö Hospital
state: Uusimaa
Study officials:
affiliation: Helsinki Uiversity Central Hospital
name: Kaisa J Virtanen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Helsinki University Central Hospital
name: Ville Remes, MD PhD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Jarkko Pajarinen, MD PhD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Vesa Savolainen, MD PhD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Jan-Magnus Björkenheim, MD PhD
role: STUDY_CHAIR
affiliation: Helsinki University Central Hospital
name: Mika P Paavola, MD PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.