Study Comparing Plate Stabilization to Conservative Treatment in Midshaft Clavicle Fractures
NCT ID: NCT01199653
Last Updated: 2010-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2004-08-31
2009-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Non-operative treatment
Non-operative (conservative) treatment of the clavicle fracture
Non-operative treatment with arm immobilised to a sling
Arm is immobilised to a sling for three weeks. Pendulum movements are allowed immediately.
Operative treatment
Operative stabilization (i.e. ORIF) of the fracture with a plate and screws.
Operative treatment
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.
Interventions
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Operative treatment
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.
Non-operative treatment with arm immobilised to a sling
Arm is immobilised to a sling for three weeks. Pendulum movements are allowed immediately.
Eligibility Criteria
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Inclusion Criteria
* fresh fracture, treatment within seven days after injury
* age between 18 and 70 years
* provided informed consent
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Helsinki University Central Hospital
OTHER
Responsible Party
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Helsinki University Central Hospital
Principal Investigators
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Kaisa J Virtanen, MD
Role: PRINCIPAL_INVESTIGATOR
Helsinki Uiversity Central Hospital
Ville Remes, MD PhD
Role: STUDY_CHAIR
Helsinki University Central Hospital
Jarkko Pajarinen, MD PhD
Role: STUDY_CHAIR
Helsinki University Central Hospital
Vesa Savolainen, MD PhD
Role: STUDY_CHAIR
Helsinki University Central Hospital
Jan-Magnus Björkenheim, MD PhD
Role: STUDY_CHAIR
Helsinki University Central Hospital
Mika P Paavola, MD PhD
Role: STUDY_DIRECTOR
Helsinki University Central Hospital
Locations
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Helsinki University Central Hospital, Töölö Hospital
Helsinki, Uusimaa, Finland
Countries
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References
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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.
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.
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.
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.
Nordqvist A, Petersson C. The incidence of fractures of the clavicle. Clin Orthop Relat Res. 1994 Mar;(300):127-32.
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.
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.
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.
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.
Other Identifiers
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T102020Z12
Identifier Type: OTHER
Identifier Source: secondary_id
TYH6267
Identifier Type: -
Identifier Source: org_study_id