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| ID | Type | Description | Link |
|---|---|---|---|
| T102020Z12 | Other Identifier | Helsinki University Central Hospital |
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The purpose of this study is to find whether to operate or treat conservatively dislocated midshaft clavicle fractures.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-operative treatment | Active Comparator | Non-operative (conservative) treatment of the clavicle fracture |
|
| Operative treatment | Active Comparator | Operative stabilization (i.e. ORIF) of the fracture with a plate and screws. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Operative treatment | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Disability of the Arm, Shoulder and Hand (DASH) | The DASH is a self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. | Three months |
| Pain at rest and activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital, Töölö Hospital | Helsinki | Uusimaa | 00260 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17200303 | Background | 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. | |
| 9250733 | Background | 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. |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D004204 | Joint Dislocations |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Non-operative treatment with arm immobilised to a sling | Procedure | Arm is immobilised to a sling for three weeks. Pendulum movements are allowed immediately. |
|
Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly. |
| Three weeks |
| Fracture healing | Fracture healing is examined from Xray. | Three months |
| Complications | Number of participants who are confronted complications such as nonunion, malunion, infection, hardware breakdown or hardware irritation. | Continous till two years |
| Disability of the Arm, Shoulder and Hand (DASH) | The DASH is a self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. | One year |
| Disabilities of the Arm, Shoulder and Hand (DASH) | The DASH is a self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. | Two years |
| Pain at rest and activity | Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly. | Six weeks |
| Pain at rest and at activity | Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly | Three months |
| Pain at rest and at activity | Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly | One year |
| Pain at rest and at activity | Pain in measured with Visual Analogue Scale (VAS) which is a psychometric response scale. It is a measurement instrument for subjective characteristics that cannot be measured directly | Two years |
| Fracture healing | Fracture healing is examined from Xray. | One year |
| Fracture healing | Fracture healing is examined from Xray. | Two years |
| 8745801 | Background | 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. |
| 14426324 | Background | 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. |
| 8131324 | Background | Nordqvist A, Petersson C. The incidence of fractures of the clavicle. Clin Orthop Relat Res. 1994 Mar;(300):127-32. |
| 15383801 | Background | 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. |
| 10775691 | Background | 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. |
| 1618563 | Background | 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. |
| 16056089 | Background | 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. |