Supraclavicular Nerve During Clavicle ORIF

NCT06050473 | Completed

• 1 other identifier: A16-535
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

Clavicle fractures are a common orthopedic injury and make up 2.6%-5% of all fractures. Despite the benefits of operative management, post-operative chest wall paresthesia is a well-known complication among surgeons and is well described in the literature. Studies reporting on the natural history of post-operative paresthesia report an incidence of chest wall numbness anywhere from 10-80% and this is attributed to iatrogenic injury of the branches of the supraclavicular nerve that provide sensation over the clavicle, anteromedial shoulder and proximal chest. While this may seem like an easy complication to avoid, anatomic studies give insight into the complex and unpredictable branching of the supraclavicular nerve. The aim of this study was to compare the area (cm2) and change in size over time of post-operative paresthesia (includes hypesthesia and dysesthesia) following ORIF of displaced clavicle fractures between nerve-sacrificing and nerve-preserving procedures.

Conditions

Clavicle Fracture

Keywords

Clavicle; Fracture; Supraclavicular nerve; Post-operative; Paresthesia

Outcome Measures

Primary Outcomes (1)

• Paresthesia mapping

  A trained research fellow will be blinded to the operative intervention performed and will measure the area of chest wall paresthesia using a transparency grid made up of 1cmx1cm squares. The transparency grid will be placed over the patient's clavicle and the patient will be instructed to palpate the chest wall for areas of paresthesia. The examiner will then outline the area of paresthesia by tracing it onto the transparency slide.

  Each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative

Secondary Outcomes (3)

• Cutaneous Hyperesthesia/dysesthesia mapping

  Each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative

• Patient Morbidity

  Prior to measuring the area of paresthesia each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative

• Disabilities of the Arm, Shoulder and Hand (DASH); A 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability).

  Prior to measuring the area of paresthesia each follow-up visit at 2 weeks post-operative, 12 weeks post-operative, 6 months post-operative, 1 year post-operative

Study Arms (2)

Supraclavicular nerve-sacrificing procedure

ACTIVE COMPARATOR

Surgeon will not attempt to identify the supraclavicular nerve branches.

Procedure: Nerve-sacrificing procedure

Supraclavicular nerve-preserving procedure

ACTIVE COMPARATOR

Surgeon will attempt to dissect out, identify and preserve all branches of the supraclavicular nerve throughout the fracture reduction, fixation and closure.

Procedure: Nerve preserving procedure

Interventions

Nerve-sacrificing procedure 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-sacrificing procedure

Nerve preserving procedure 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.

Supraclavicular nerve-preserving procedure

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>17 years old with a displaced, midshaft clavicle fracture
• Closed injury
• No skin compromise

You may not qualify if:

• Clavicle non-union/malunion
• 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

Sponsors & Collaborators

• HealthPartners Institute: lead

Related Publications (25)

• Jeray KJ. Acute midshaft clavicular fracture. J Am Acad Orthop Surg. 2007 Apr;15(4):239-48. doi: 10.5435/00124635-200704000-00007.

  PMID: 17426295 BACKGROUND

• 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.

  PMID: 24662990 BACKGROUND

• 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.

  PMID: 28816894 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.

  PMID: 17200303 BACKGROUND

• 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.

  PMID: 24005198 BACKGROUND

• 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.

  PMID: 29672340 BACKGROUND

• 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.

  PMID: 20936387 BACKGROUND

• 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.

  PMID: 34732198 BACKGROUND

• 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.

  PMID: 17851634 BACKGROUND

• 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.

  PMID: 16838268 BACKGROUND

• 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.

  PMID: 20219192 BACKGROUND

• 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.

  PMID: 25651293 BACKGROUND

• 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.

  PMID: 30187099 BACKGROUND

• 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.

  PMID: 26018526 BACKGROUND

• 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.

  PMID: 33966101 BACKGROUND

• 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.

  PMID: 29890301 BACKGROUND

• 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.

  PMID: 33131791 BACKGROUND

• 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.

  PMID: 29256945 BACKGROUND

• 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.

  PMID: 21761252 BACKGROUND

• 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.

  PMID: 31448305 BACKGROUND

• 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.

  PMID: 31851115 BACKGROUND

• Larsson S. Clavicula fractures: considerations when plating. Injury. 2018 Jun;49 Suppl 1:S24-S28. doi: 10.1016/S0020-1383(18)30298-5.

  PMID: 29929688 BACKGROUND

• 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.

  PMID: 26770963 BACKGROUND

• 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.

  PMID: 27225678 BACKGROUND

• 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.

  PMID: 22430514 BACKGROUND

MeSH Terms

Conditions

Fractures, Bone; Paresthesia

Condition Hierarchy (Ancestors)

Wounds and Injuries; Somatosensory Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter A Cole, MD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants blinded to the cohort they are randomized to (i.e., nerve-sparing group vs nerve-sacrificing group). Care providers were blinded to the randomization and made aware of the patient's cohort just prior to surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 22, 2023
• Study Start: November 2, 2016
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share