Study Results
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Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2016-11-02
2023-08-10
Brief Summary
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Detailed Description
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1. Group 1 - Operative treatment utilizing a supraclavicular nerve-sacrificing procedure
2. Group 2 - Operative treatment utilizing a supraclavicular nerve-preserving procedure
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Supraclavicular nerve-sacrificing procedure
Surgeon will not attempt to identify the supraclavicular nerve branches.
Nerve-sacrificing procedure
Surgical fixation of the clavicle fracture will be performed through a horizontal incision over the clavicle. During the incision and soft tissue dissection, the surgeon will not attempt to identify the supraclavicular nerve branches. Instead, the surgeon will cut the nerve branches during the dissection.
Supraclavicular nerve-preserving procedure
Surgeon will attempt to dissect out, identify and preserve all branches of the supraclavicular nerve throughout the fracture reduction, fixation and closure.
Nerve preserving procedure
Surgical fixation of the clavicle fracture will be performed through the same horizontal incision over the clavicle. The surgeon will attempt to dissect out, identify and preserve all branches of the supraclavicular nerve throughout the fracture reduction, fixation and closure.
Interventions
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Nerve-sacrificing procedure
Surgical fixation of the clavicle fracture will be performed through a horizontal incision over the clavicle. During the incision and soft tissue dissection, the surgeon will not attempt to identify the supraclavicular nerve branches. Instead, the surgeon will cut the nerve branches during the dissection.
Nerve preserving procedure
Surgical fixation of the clavicle fracture will be performed through the same horizontal incision over the clavicle. The surgeon will attempt to dissect out, identify and preserve all branches of the supraclavicular nerve throughout the fracture reduction, fixation and closure.
Eligibility Criteria
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Inclusion Criteria
* Closed injury
* No skin compromise
Exclusion Criteria
* Far proximal (medial) or far distal (lateral) clavicle fractures
* Open injury
* Skin compromise
* Prior surgery of the anterior chest wall or affected clavicle
* Pre-existing chest wall numbness, cervical root symptoms, neurologic or sensory deficits, signs of neuropathy
* We will not exclude patients on membrane stabilizing medications for nerve paresthesia (GABA agonists, tricyclic anti-depressants) but will include this on patient intake form and document it
* Traumatic brain injury
* Patients who had prior deltopectoral approach to glenoid
17 Years
ALL
Yes
Sponsors
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HealthPartners Institute
OTHER
Responsible Party
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Principal Investigators
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Peter A Cole, MD
Role: PRINCIPAL_INVESTIGATOR
HealthPartners Institute
References
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Jeray KJ. Acute midshaft clavicular fracture. J Am Acad Orthop Surg. 2007 Apr;15(4):239-48. doi: 10.5435/00124635-200704000-00007.
Christensen TJ, Horwitz DS, Kubiak EN. Natural history of anterior chest wall numbness after plating of clavicle fractures: educating patients. J Orthop Trauma. 2014 Nov;28(11):642-7. doi: 10.1097/BOT.0000000000000095.
Ahrens PM, Garlick NI, Barber J, Tims EM; Clavicle Trial Collaborative Group. The Clavicle Trial: A Multicenter Randomized Controlled Trial Comparing Operative with Nonoperative Treatment of Displaced Midshaft Clavicle Fractures. J Bone Joint Surg Am. 2017 Aug 16;99(16):1345-1354. doi: 10.2106/JBJS.16.01112.
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.
Robinson CM, Goudie EB, Murray IR, Jenkins PJ, Ahktar MA, Read EO, Foster CJ, Clark K, Brooksbank AJ, Arthur A, Crowther MA, Packham I, Chesser TJ. Open reduction and plate fixation versus nonoperative treatment for displaced midshaft clavicular fractures: a multicenter, randomized, controlled trial. J Bone Joint Surg Am. 2013 Sep 4;95(17):1576-84. doi: 10.2106/JBJS.L.00307.
Ahmed AF, Salameh M, AlKhatib N, Elmhiregh A, Ahmed GO. Open Reduction and Internal Fixation Versus Nonsurgical Treatment in Displaced Midshaft Clavicle Fractures: A Meta-Analysis. J Orthop Trauma. 2018 Jul;32(7):e276-e283. doi: 10.1097/BOT.0000000000001174.
Nathe T, Tseng S, Yoo B. The anatomy of the supraclavicular nerve during surgical approach to the clavicular shaft. Clin Orthop Relat Res. 2011 Mar;469(3):890-4. doi: 10.1007/s11999-010-1608-x. Epub 2010 Oct 9.
Lemieux V, Afsharpour S, Nam D, Elmaraghy A. Incisional paresthesia following clavicle plate fixation: does it matter to patients? BMC Musculoskelet Disord. 2021 Nov 3;22(1):928. doi: 10.1186/s12891-021-04770-z.
Havet E, Duparc F, Tobenas-Dujardin AC, Muller JM, Freger P. Morphometric study of the shoulder and subclavicular innervation by the intermediate and lateral branches of supraclavicular nerves. Surg Radiol Anat. 2007 Dec;29(8):605-10. doi: 10.1007/s00276-007-0258-5. Epub 2007 Sep 13.
Jelev L, Surchev L. Study of variant anatomical structures (bony canals, fibrous bands, and muscles) in relation to potential supraclavicular nerve entrapment. Clin Anat. 2007 Apr;20(3):278-85. doi: 10.1002/ca.20368.
Wang K, Dowrick A, Choi J, Rahim R, Edwards E. Post-operative numbness and patient satisfaction following plate fixation of clavicular fractures. Injury. 2010 Oct;41(10):1002-5. doi: 10.1016/j.injury.2010.02.028. Epub 2010 Mar 12.
Erdogan M, Desteli EE, Imren Y, Kilic M, Ulusoy S, Varli A. Supraclavicular neuropathy after surgical treatment of clavicular fractures: comparison of two incisions. Acta Chir Orthop Traumatol Cech. 2014;81(6):387-91.
Chechik O, Batash R, Goldstein Y, Snir N, Amar E, Drexler M, Maman E, Dolkart O. Surgical approach for open reduction and internal fixation of clavicle fractures: a comparison of vertical and horizontal incisions. Int Orthop. 2019 Aug;43(8):1977-1982. doi: 10.1007/s00264-018-4139-9. Epub 2018 Sep 5.
Beirer M, Postl L, Cronlein M, Siebenlist S, Huber-Wagner S, Braun KF, Biberthaler P, Kirchhoff C. Does a minimal invasive approach reduce anterior chest wall numbness and postoperative pain in plate fixation of clavicle fractures? BMC Musculoskelet Disord. 2015 May 28;16:128. doi: 10.1186/s12891-015-0592-4.
Ko SH, Kim MS. Comparison of supraclavicular nerve injuries after clavicle mid-shaft surgery via minimally invasive plate osteosynthesis versus open reduction and internal fixation. Arch Orthop Trauma Surg. 2022 Aug;142(8):1895-1902. doi: 10.1007/s00402-021-03941-w. Epub 2021 May 9.
You JM, Wu YS, Wang Y. Comparison of post-operative numbness and patient satisfaction using minimally invasive plate osteosynthesis or open plating for acute displaced clavicular shaft fractures. Int J Surg. 2018 Aug;56:21-25. doi: 10.1016/j.ijsu.2018.06.007. Epub 2018 Jun 8.
Huang D, Deng Y, Cheng J, Bong YR, Schwass M, Policinski I. Comparison of patient reported outcomes following clavicle operative fixation using supraclavicular nerve sparing and supraclavicular nerve sacrificing techniques- A cohort study. Injury. 2021 Mar;52(3):501-505. doi: 10.1016/j.injury.2020.10.100. Epub 2020 Oct 27.
Meinberg EG, Agel J, Roberts CS, Karam MD, Kellam JF. Fracture and Dislocation Classification Compendium-2018. J Orthop Trauma. 2018 Jan;32 Suppl 1:S1-S170. doi: 10.1097/BOT.0000000000001063. No abstract available.
Laffosse JM, Potapov A, Malo M, Lavigne M, Vendittoli PA. Hypesthesia after anterolateral versus midline skin incision in TKA: a randomized study. Clin Orthop Relat Res. 2011 Nov;469(11):3154-63. doi: 10.1007/s11999-011-1973-0. Epub 2011 Jul 15.
O'Connor CM, Ring D. Correlation of Single Assessment Numeric Evaluation (SANE) with other Patient Reported Outcome Measures (PROMs). Arch Bone Jt Surg. 2019 Jul;7(4):303-306.
Amer K, Smith B, Thomson JE, Congiusta D, Reilly MC, Sirkin MS, Adams MR. Operative Versus Nonoperative Outcomes of Middle-Third Clavicle Fractures: A Systematic Review and Meta-Analysis. J Orthop Trauma. 2020 Jan;34(1):e6-e13. doi: 10.1097/BOT.0000000000001602.
Larsson S. Clavicula fractures: considerations when plating. Injury. 2018 Jun;49 Suppl 1:S24-S28. doi: 10.1016/S0020-1383(18)30298-5.
Devji T, Kleinlugtenbelt Y, Evaniew N, Ristevski B, Khoudigian S, Bhandari M. Operative versus nonoperative interventions for common fractures of the clavicle: a meta-analysis of randomized controlled trials. CMAJ Open. 2015 Nov 10;3(4):E396-405. doi: 10.9778/cmajo.20140130. eCollection 2015 Oct-Dec.
Ban I, Nowak J, Virtanen K, Troelsen A. Overtreatment of displaced midshaft clavicle fractures. Acta Orthop. 2016 Dec;87(6):541-545. doi: 10.1080/17453674.2016.1191275. Epub 2016 May 26.
O'Neill K, Stutz C, Duvernay M, Schoenecker J. Supraclavicular nerve entrapment and clavicular fracture. J Orthop Trauma. 2012 Jun;26(6):e63-5. doi: 10.1097/BOT.0b013e31822c0796.
Other Identifiers
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A16-535
Identifier Type: -
Identifier Source: org_study_id
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