WO2021038178A1 - Plaque d'ostéosynthèse - Google Patents

Plaque d'ostéosynthèse Download PDF

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Publication number
WO2021038178A1
WO2021038178A1 PCT/GB2019/052429 GB2019052429W WO2021038178A1 WO 2021038178 A1 WO2021038178 A1 WO 2021038178A1 GB 2019052429 W GB2019052429 W GB 2019052429W WO 2021038178 A1 WO2021038178 A1 WO 2021038178A1
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WO
WIPO (PCT)
Prior art keywords
bone
plate
securing
clavicle
fracture
Prior art date
Application number
PCT/GB2019/052429
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English (en)
Inventor
Graham TYTHERLEIGH-STRONG
Original Assignee
Tytherleigh Strong Graham
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Tytherleigh Strong Graham filed Critical Tytherleigh Strong Graham
Priority to PCT/GB2019/052429 priority Critical patent/WO2021038178A1/fr
Publication of WO2021038178A1 publication Critical patent/WO2021038178A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8061—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones

Definitions

  • the present invention relates to bone plates for securing bone discontinuities, in particular the present invention relates to twisted bone plates that allow for fixation of bone discontinuities.
  • a number of fixation methods including various types of sutures, wires, screws, and plate configurations, have been described to treat medial end clavicular fractures (Bartonicek et al; Fransen et al; Gille et al; Kim et al; Oe et al; Sidhu et al; Stark et al). These have generally been as case reports or very small cases series with varying levels of success. Kirschner wires have been used alone, but these tend to be insufficient and may migrate (Bartonicek et al; Fransen et al). A hook plate has been used, with the hook in the sternum itself inducing a temporary arthrodesis; this also requires removal (Gille et al).
  • Tension band sutures have been used, offering limited stability. They are less suitable for larger fragments, although they may be used in combination with a T plate, which may also be used alone (Kim et al). Even a staged procedure of medial clavicular fixation and middle clavicular offloading osteotomy with delayed osteotomy fixation has been attempted (Al-Yassari et al).
  • Fixing the plate onto the superior surface of the medial end of the clavicle may compromise or damage the clavicular insertion of sternocleidomastoid (SCM) muscle and, due to the close proximity of the patient's head and neck, compromise and limit the number of precisely positioned screws; and of the 25 patients in their series, including 6 patients who had an osseous suture fixation, 17 reported symptoms of plate or wound irritation, and 3 patients felt this to be sufficiently severe to undergo elective removal of the hardware.
  • SCM sternocleidomastoid
  • a lateral clavicle locking plate that is twisted through 90°.
  • the plate described herein allows for the medial end of the plate to be fixed to the anterior surface of the clavicle with multiple small unicortical locking screws and the lateral end of the plate to be twisted and fixed to the superior surface of the clavicle.
  • a bone plate for securing a bone discontinuity comprising a first region with a first securing portion; a second region with a second securing portion; and an elongate portion between the first and second securing portions; wherein the plate is twisted about its longitudinal axis such that the first and second securing portions lie in different planes about the axis.
  • the plate is twisted about its longitudinal axis at an angle such that the first securing portion lies in a plane that is perpendicular to the second securing portion. In a preferred embodiment, the plate is twisted about its longitudinal axis through 90°. This allows for the plate to be secured more easily, for example in the case of securing a bone discontinuity in the clavicle, as the plate can be fixed onto the anterior medial end of the clavicle and the superior lateral end of the clavicle so as the head and neck structures do not obscure access, and damage to the SCM muscle is avoided.
  • a surface of the plate that, in use, contacts a bone is contoured to fit the curvature of the bone. This allows for the plate to be more closely fitted to the bone, as there is no angular mismatch and will consequently allow better healing of the bone discontinuity.
  • the bone plate is made of made of biocompatible material, high- grade titanium, titanium alloy or stainless steel. This allows the plate to be left inside the body, without need for an operation to remove the plate once the bone discontinuity is healed.
  • first and second securing portions each comprise at least one hole for receiving a screw.
  • the elongate portion also comprises at least one hole for a screw for securing the elongate portion to a bone. This will allow for further securing of the plate to the bone, to prevent the plate migrating.
  • Said holes may be of varying diameter sizes to accommodate screws of varying diameter sizes.
  • Screws may be locking unicortical screws (i.e. passes through only the near bone cortex) or locking/non-locking bicortical screws (i.e. passes through both the near and far bone cortices). Bicortical screws generally allow for strong fixation to bone than unicortical screws, however the drilling of bicortical screws comes with an increased risk of damage to structures proximal to the posterior side of the bone.
  • the first or the second securing portion is broadened or flared. This gives an increased surface area for fixation to the bone, for example in the case of a medial end clavicle fracture, where there may only be a relatively small portion of the bone to secure the first or second securing portion to.
  • This larger surface area allows for a greater number of holes for receiving screws, meaning that multiple small unicortical locking screws can be used to provide sufficiently strong fixation to the bone, rather than fewer larger bicortical screws which may cause damage to the posterior cortex and neurovascular structures in proximity to the posterior of the medial end of the bone.
  • the width of the plate tapers along at least a portion of the elongate portion from the broadened or flared first or second securing region towards the other of the second or first securing region. In an alternative embodiment, the width of the plate steps down at the interface between the broadened or flared first or second securing region and the elongate portion.
  • the bone discontinuity when the plate is in use, is located at the end portion of a bone.
  • the bone discontinuity is a medial end clavicular fracture.
  • the first securing region is secured to a first portion of a bone
  • the second securing region is secured to a second portion of a bone, the first and second portion of the bone being located either side of a bone discontinuity, and wherein the elongate portion spans the bone discontinuity.
  • a method of treating a clavicle fracture comprising performing surgery to secure the bone plate of any preceding claim to a clavicle bone, the clavicle bone having a fracture and the bone plate spanning said fracture and thus securing the fracture and allowing the fracture to heal.
  • Figure 1 shows the anatomical structures that can affect plate fixation of the medial end of the clavicle bone.
  • Figure 2 shows a plan view of a bone plate in untwisted form.
  • Figure 3 shows an end-on view of a bone plate in untwisted form.
  • Figure 4 shows a twisted lateral clavicle locking plate of the invention.
  • Figure 5 shows a typical clavicle fracture prior to treatment.
  • Figure 6 shows the union of a typical clavicle fracture after use of a bone plate of the invention.
  • Figure 7 shows a typical clavicle fracture before and after fixation with a bone plate of the invention.
  • Figure 8 shows patient demographic and outcome data for those who have received a bone plate of the invention.
  • Figure 9 shows perspective views of an exemplary example of a bone plate of the invention.
  • the present invention provides a bone plate for securing a bone discontinuity, wherein the bone plate is twisted about its longitudinal axis such that the first and second securing portions lie in different planes about that axis.
  • Figure 4 shows twisted lateral clavicle locking plates 100 in use on a clavicular bone 200 having a medial end 201 and a lateral end 202.
  • Figures 2 and 3 show the lateral clavicle locking plates in their untwisted form.
  • the bone plate 100 has a first securing portion 101 , a second securing portion 102, and an elongate portion 103 between the first and second securing portions, with a tapering of the plate width along its width from the first securing portion to the elongate portion.
  • the first securing portion 101 , second securing portion 102 and elongate portion 103 all have holes 104 for receiving screws. This allows for the first securing portion 101 to be secured to the medial end of the bone 201 , the elongate portion 103 to be secured to the area of the bone where the fracture may be located 203, and the second securing portion to be secured to the lateral end of the bone 202.
  • (A) and (B) show a shorter plate with 13 holes 104 for receiving screws, whereas (C) shows a longer plate with 16 holes 104 for receiving screws.
  • This bone plate provides a number of advantages and these advantages are described and exemplified herein.
  • a straight plate is positioned on the superior aspect of the clavicle bone the sternoclaedomastoid muscle (SCM) insertion can be damaged by drilling and fixing the plate, and there is the potential for vascular compromise due to the high vascular network in this region (see Figure 1 B) and there is difficulty in drilling and inserting the screws perpendicular to the plate as the head and neck (particularly the skull) are in the way (see Figure 1A). If a straight plate is positioned on the anterior surface of the clavicle there is also a risk of damage to the vascular structures posterior to the clavicle (see Figure 1 C).
  • the flared end of the plate could be positioned over the anterior surface of the medial end of the clavicle, permitting an unhindered drill trajectory and screw insertion to every screw hole available within the plate.
  • the only compromise is that the preset peripheral locking screw angles in the plate are divergent to accommodate the broader, superior surface of the lateral clavicle.
  • the anterior surface of the medial end of the clavicle is less broad, and some of the peripheral holes may require non-locking screws.
  • a further benefit of the plate of the invention is that the twisted shape of the bone plate allows for the use of locking bicortical screws in the portion of the plate which is fixed to the bone in a plane wherein drilling is not in the direction of important anatomical structures.
  • this is the non-broadened/flared portion of the plate which is fixed to the superior surface of the clavicle bone, lateral to the fracture, and can therefore use bicortical screws.
  • the broadened portion of the plate can be sufficiently fixed to the bone, medial to the fracture, using multiple smaller unicortical screws, providing strong fixation whilst avoiding damage from drilling towards posterior anatomical structures. Therefore, the twisted bone plate of the invention offers accurate insertion without compromising important structures that insert into the bone, as well as providing improved access for screwing of the plate.
  • the plate of the present invention provides a better fit to the bone than is seen with existing plates (particularly relatively long plates), as there is no “angular mis match”. Further, as described herein, there are decreased complications following the surgery because fixation with the bone plate of the present invention will be more successful than non-twisted bone plates. A more effective bone fixation ultimately allows for better patient recovery, as well as improved cosmesis, and indeed none of the patients that have been treated with a twisted bone plate of the invention have experienced or reported a complication. Although two patients felt that their metalwork was slightly prominent, they chose not to have this removed. Notably, all patients said that they would be happy to undergo the procedure again if a similar fracture were to occur on the contralateral side.
  • FIGs 5 and 6 show anteroposterior x-ray (A) and 3 dimensional reconstruction computed tomography scan (B) images of a patient with a comminuted fracture of the medial end of left clavicle ( Figure 5), and the same patient six months post-surgery ( Figure 6) having been treated with a twisted clavicle plate such as the one represented in Figure 4, demonstrating the fitting of the plate to the bone and successful union of the fracture.
  • Figure 7 shows serial plain x-ray images and an axial computed tomography scan of a right medial end clavicular fracture before and after fixation. At 4 weeks after fixation, there is still evidence of an inferior cortical discontinuity. At 4 months after fixation, callus can be seen inferiorly bridging the fracture with cortical continuity. Flowever, at 6 months there has been further consolidation of the fracture healing.
  • Surgical databases were searched and 8 patients were identified who underwent an open reduction and internal fixation using a contoured locking plate for an acute displaced medial fifth clavicular fracture. Exclusion criteria included an additional associated injury to the shoulder girdle (clavicle or scapula), previous clavicular fracture or injury to the sternoclavicular joint (SCJ), and a delayed or established non-union.
  • the improved bone plate 100 can be seen in Figure 11 in use on clavicular bone 200 having a medial end 201 and a lateral end 202.
  • the bone plate 100 has a first securing portion 101 , a second securing portion 102, and an elongate portion 103 between the first and second securing portions, with a rapid step down in width along the length between the first securing portion 101 and the elongate portion 103, creating a narrowed portion 105.
  • the first securing portion 101 , second securing portion 102 and elongate portion 103 all have holes 104 for receiving screws. This allows for the first securing portion 101 to be secured to the medial end of the bone 201 , the elongate portion 103 to be secured to the area of the bone where the fracture may be located 203, and the second securing portion to be secured to the lateral end of the bone 202. This allows for secure fixation of bone plate 100 to a left clavicle bone 200.
  • an advantage of this embodiment is that the first securing portion 101 is broadened, allowing for an increased amount of holes 104 for receiving screws, in this embodiment there are three rows of three holes 104 for receiving screws to provide improved fixture to a bone 200, particularly at the medial end of said bone 201 . This is especially important when the fracture occurs at the medial end of the bone 201 , as there is often a small area of bone that a plate can be secured to.
  • the first securing portion 101 is also contoured 105 to fit the curvature of the medial end of the bone 201 . This allows for better fitting to the anterior side of the medial end of the clavicle bone 201.
  • a further advantage is that the rapid step down in width along the length between the first securing portion 101 and the elongate portion 103 results in a narrowed portion 105 allowing for a better fit to the bone with a reduction in the overall size of the plate.
  • a twisted bone plate can be applied in a variety of contexts wherein fixation of a bone discontinuity is desired.
  • the bone plate of the present invention can be used advantageously to fix a fracture in other bones, such as the humeral shaft.
  • the use of the bone plate of the present invention to fix a fracture in the humeral shaft allows for the avoidance of a neurological structure called the radial nerve, which twists around the humeral shaft from medial to lateral and is in danger of being damaged during certain surgical approaches. Care must be taken to find this nerve and, on occasion, it is necessary to mobilise the nerve and pass the plate under it. This is particularly for posterior and anterior-lateral approaches. A twisted plate may avoid this.
  • Robinson CM Fractures of the clavicle in the adult. Epidemiology and classification. J Bone Joint Surg Br 1998;80:476-84. Robinson CM, Court-Brown CM, McQueen MM, Wakefield AE. Estimating the risk of nonunion following nonoperative treatment of a clavicular fracture. J Bone Joint Surg Am 2004;86-A:1359- 65. Sidhu VS, Hermans D, Duckworth DG. The operative outcomes of displaced medial-end clavicle fractures. J Shoulder Elbow Surg 2015;24:1728-34. Stark MJ, DeFranco MJ. Elastic intramedullary nailing of a medial clavicle fracture in a pediatric patient. Case Rep Orthop 2017;2017: 6354284.
  • Throckmorton T Kuhn JE. Fractures of the medial end of the clavicle. J Shoulder Elbow Surg 2007;16:49-54.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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Abstract

Plaque d'ostéosynthèse (100) destinée à stabiliser une discontinuité osseuse, telle qu'une fracture. La plaque d'ostéosynthèse comprend une première région comportant une première partie de fixation (101), une seconde région comportant une seconde partie de fixation (102) et une partie allongée (103) entre les première et seconde parties de fixation. En particulier, la plaque est torsadée autour de son axe longitudinal de telle sorte que les première et seconde parties de fixation (101) et (102) se situent dans des plans différents autour de l'axe. Ainsi, lors de l'utilisation, la première région de fixation (101) est fixée à une première partie d'un os (201), la seconde région de fixation (102) est fixée à une seconde partie d'un os (202), les première et seconde parties de l'os étant situées de part et d'autre d'une discontinuité osseuse, la partie allongée (103) enjambant la discontinuité osseuse.
PCT/GB2019/052429 2019-08-30 2019-08-30 Plaque d'ostéosynthèse WO2021038178A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/GB2019/052429 WO2021038178A1 (fr) 2019-08-30 2019-08-30 Plaque d'ostéosynthèse

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Application Number Priority Date Filing Date Title
PCT/GB2019/052429 WO2021038178A1 (fr) 2019-08-30 2019-08-30 Plaque d'ostéosynthèse

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WO2021038178A1 true WO2021038178A1 (fr) 2021-03-04

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090143825A1 (en) * 2007-11-30 2009-06-04 Robert Graham Distal Tibia Plating System
US20110184414A1 (en) * 2010-01-27 2011-07-28 Jonas Andermahr System and Method for Minimally Invasive Clavicle Plate Application
CN103505279A (zh) * 2012-06-25 2014-01-15 宋文生 锁骨中段三维异形接骨板
US20160310183A1 (en) * 2015-04-22 2016-10-27 Anup A. Shah Proximal humeral fracture plate

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090143825A1 (en) * 2007-11-30 2009-06-04 Robert Graham Distal Tibia Plating System
US20110184414A1 (en) * 2010-01-27 2011-07-28 Jonas Andermahr System and Method for Minimally Invasive Clavicle Plate Application
CN103505279A (zh) * 2012-06-25 2014-01-15 宋文生 锁骨中段三维异形接骨板
US20160310183A1 (en) * 2015-04-22 2016-10-27 Anup A. Shah Proximal humeral fracture plate

Non-Patent Citations (19)

* Cited by examiner, † Cited by third party
Title
AL-YASSARI GHETZENAUER MTAUBER MRESCH H: "Novel method to treat sternoclavicular joint instability and medial clavicle fracture symptomatic nonunion", J SHOULDER ELBOW SURG, vol. 18, 2009, pages 553 - 5, XP026217403, doi:10.1016/j.jse.2008.11.011
BARTONICEK JFRIC VPACOVSKY V: "Displaced fractures of the medial end of the clavicle: report of five cases", J ORTHOP TRAUMA, vol. 24, 2010, pages e31 - 5
CORRALES LAMORSHED SBHANDARI MMICLAU T 3RD: "Variability in the assessment of fracture-healing in orthopaedic trauma studies", J BONE JOINT SURG AM, vol. 90, 2008, pages 1862 - 8
FRANSEN PBOURGEOIS SROMMENS J.: "Kirschner wire migration causing spinal cord injury one year after internal fixation of a clavicle fracture", ACTA ORTHOP BELG, vol. 73, 2007, pages 390 - 2
GILLE JSCHULZ AWALLSTABE SUNGER AVOIGT CFASCHINGBAUER M.: "Hook plate for medial clavicle fracture", INDIAN J ORTHOP, vol. 44, 2010, pages 221 - 3
GUMMESSON CWARD MMATROSHI I: "The shortened Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH): validity and reliability based on responses within the full-length DASH", BMC MUSCULOSKELET DISORD, vol. 7, 2006, pages 44, XP021016857, doi:10.1186/1471-2474-7-44
KIM KCSHIN HDCHA SM: "Surgical treatment of displaced medial clavicle fractures using a small T-shaped plate and tension band sutures", ARCH ORTHOP TRAUMA SURG, vol. 131, 2011, pages 1673 - 6, XP019977247, doi:10.1007/s00402-011-1367-5
LOW AKDUCKWORTH DGBOKOR DJ: "Operative outcome of displaced medial-end clavicle fractures in adults", J SHOULDER ELBOW SURG, vol. 17, 2008, pages 751 - 4, XP025763496, doi:10.1016/j.jse.2008.01.139
MORSHED SCORRALES LGENANT HMICLAU T 3RD: "Outcome assessment in clinical trials of fracture-healing", J BONE JOINT SURG AM, vol. 90, no. 1, 2008, pages 62 - 7
NOWAK JHOLGERSSON MLARSSON S: "Sequelae from clavicular fractures are common: a prospective study of 222 patients", ACTA ORTHOP, vol. 76, 2005, pages 496 - 502
OE KGAUL LHIERHOLZER CWOLTMANN AMIWA MKUROSAKA M ET AL.: "Operative management of periarticular medial clavicle fractures-report of 10 cases", J TRAUMA ACUTE CARE SURG, vol. 72, 2012, pages E1 - 7
ROBINSON CM: "Fractures of the clavicle in the adult. Epidemiology and classification", J BONE JOINT SURG BR, vol. 80, 1998, pages 476 - 84
ROBINSON CMCOURT-BROWN CMMCQUEEN MMWAKEFIELD AE: "Estimating the risk of nonunion following nonoperative treatment of a clavicular fracture", J BONE JOINT SURG AM, vol. 86-A, 2004, pages 1359 - 65
SIDHU VSHERMANS DDUCKWORTH DG: "The operative outcomes of displaced medial-end clavicle fractures", J SHOULDER ELBOW SURG, vol. 24, 2015, pages 1728 - 34
STARK MJDEFRANCO MJ: "Elastic intramedullary nailing of a medial clavicle fracture in a pediatric patient", CASE REP ORTHOP, vol. 2017, 2017, pages 6354284
THROCKMORTON TKUHN JE: "Fractures of the medial end of the clavicle", J SHOULDER ELBOW SURG, vol. 16, 2007, pages 49 - 54, XP005832315, doi:10.1016/j.jse.2006.05.010
TOKIYOSHI A: "New technique to fix a medial clavicle fracture", TECHNIQ SHOULDER ELBOW SURG, vol. 15, 2014, pages 60 - 2
TYTHERLEIGH-STRONG GRASHID ALAWRENCE CMORRISSEY D: "Arthroscopic intra-articular disk excision of the sternoclavicular joint", ARTHROSC TECH, vol. 6, 2017, pages e599 - 605
WANG YJIANG JDOU BZHANG P: "Inverted distal clavicle anatomic locking plate for displaced medial clavicle fracture", ARCH ORTHOP TRAUMA SURG, vol. 135, 2015, pages 1241 - 5

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