ORTHOKIDS PRECISE DE-ROTATION JIG FOR ROTATIONAL OSTEOTOMIES OF HUMERUS

Abstract

The present invention relates to a Precise De-rotation Jig designed for accurate rotational osteotomies in pediatric patients with residual Brachial Plexus Birth Injuries (BPBI). This surgical device consists of three components: a compression plate for securing the proximal humerus, a central pillar with adjustable height to match the patient’s bone size, and a goniometric-rotational (GR) guide for precise measurement of rotational angles in increments of 5° to 45°. The jig allows for accurate de-rotation of the humeral fragments, reducing errors caused by traditional methods such as visual estimation and preventing over- or under-correction. It ensures correct alignment of K-wires during the procedure, minimizing the risk of iatrogenic nerve injury. The device enhances surgical precision, improves functional outcomes (e.g., hand-to-mouth, hand-to-neck), and offers a safer, more efficient solution for performing humeral osteotomies in pediatric patients with BPBI. Refer Figure 1.

Specification

Description:ORTHOKIDS PRECISE DE-ROTATION JIG FOR ROTATIONAL OSTEOTOMIES OF HUMERUS

FIELD OF THE INVENTION:

⦁ The present invention relates to a surgical device for performing precise rotational osteotomies, specifically for the correction of humeral deformities in pediatric patients with residual Brachial Plexus Birth Injuries (BPBI). More particularly, the invention pertains to an apparatus that allows for accurate intraoperative measurement and adjustment of rotational correction during humeral osteotomy procedures, addressing limitations in current techniques. The device enables surgeons to achieve optimal de-rotation of bone segments, thereby minimizing errors such as over-correction or under-correction, which can lead to functional impairments or parental dissatisfaction. The invention provides a means to reliably measure and correct humeral rotation by utilizing a jig system with a compression plate, central pillar, and a goniometric-rotational guide (GR guide), offering a precise, error-free method for guiding the osteotomy and achieving the desired rotational alignment.

BACKGROUND OF THE INVENTION:

⦁ Rotational osteotomies of humerus are commonly performed to correct limb deformities in pediatric patients with residual Brachial Plexus Birth Injuries (BPBI). These deformities often result in abnormal limb positioning and limited functional range of motion. In the case of BPBI, a common issue is the internal rotation deformity of the humerus, often caused by glenohumeral joint incongruity. To address these deformities, rotational osteotomies are routinely performed to improve functional outcomes and restore normal range of motion.
⦁ However, despite the frequent use of humeral rotational osteotomies in the pediatric population, there is currently no universally accepted technique for accurately measuring and achieving the correct amount of rotational correction during surgery. Several methods have been described in the literature for determining the angle of rotation, often relying on subjective, intraoperative clinical judgment. For example, surgeons typically assess the desired rotation by testing the range of motion-checking for hand-to-mouth or hand-to-belly movements to estimate the appropriate amount of external rotation. While these clinical assessments can provide useful feedback, they are inherently imprecise and prone to variability.
⦁ The main challenge during humeral osteotomy procedures is achieving the correct rotational alignment. Over-correction, where the humerus is rotated too far externally, can result in loss of midline function, reducing the child's ability to perform daily tasks such as bringing the hand to the mouth or neck. Conversely, under-correction, where the humerus is not rotated enough, can limit functional range of motion, affecting the child's ability to perform these essential movements. Both outcomes can lead to functional impairment and parental dissatisfaction, making precise measurement and correction of rotation crucial.
⦁ Current intraoperative techniques for determining the angle of rotation often involve placing K-wires in the proximal and distal bone fragments at the desired correction angles. The K-wire placement methods, however, are prone to significant errors. One common method involves placing the K-wire in alignment with a screw hole in the plate, but this can result in parallax errors and make it difficult to clearly visualize the wire placement due to obstruction by the plate. Another technique involves placing the K-wire beyond the plate, which requires additional exposure and increases the risk of iatrogenic injury to nearby neurovascular structures. Furthermore, these methods can lead to difficulties in achieving precise alignment during the rotation maneuver, with the potential for the K-wire to bend or shift, further complicating the correction process.
⦁ To address these limitations, a new surgical device has been developed that provides a more accurate and reliable method for measuring and correcting humeral rotation during osteotomy. The device is designed to eliminate the inherent errors of previous techniques, providing surgeons with a tool to achieve precise rotational alignment while minimizing the risks associated with K-wire placement and rotational inaccuracies. The novel device consists of a compression plate, a central pillar, and a goniometric-rotational guide (GR guide) that works together to accurately measure and guide the de-rotation of the bone fragments, ensuring optimal correction with minimal risk of over-correction or under-correction. This invention represents a significant improvement over existing methods by providing a standardized and reliable approach to humeral rotational osteotomy, ultimately leading to better functional outcomes for pediatric patients with BPBI.

OBJECTIVES OF THE INVENTION:
⦁ The main objective of the present invention is to provide a surgical device and method for performing precise rotational osteotomies in pediatric patients with residual Brachial Plexus Birth Injuries (BPBI), specifically for correcting humeral internal rotation deformities. The device aims to achieve accurate and reliable measurement of rotational correction during osteotomy procedures, thereby improving surgical outcomes and minimizing the risk of over-correction or under-correction.
⦁ Another objective of the present invention is to provide a surgical jig system that enables precise measurement and correction of humeral rotation during osteotomy procedures, overcoming the limitations and inaccuracies associated with current intraoperative techniques.
⦁ Yet another objective of the present invention is to eliminate errors in rotational alignment by providing a device that facilitates accurate positioning of K-wires in the proximal and distal bone fragments, ensuring correct alignment of the humerus in both the internal and external rotation directions.
⦁ Still Another objective of the present invention is to reduce the risk of iatrogenic injury to neurovascular structures during the surgical procedure by offering an improved method for K-wire placement, avoiding the need for excessive exposure or external wire insertion through the skin.
⦁ Further objective of the invention is to improve the consistency and reproducibility of the rotational correction by using a standardized device that can be easily adjusted to different bone diameters, providing the surgeon with a clear and precise method to achieve the desired amount of external rotation.
⦁ Yet further objective the invention is to enhance functional outcomes for pediatric patients undergoing humeral osteotomies for BPBI by ensuring that the desired range of motion-such as hand-to-mouth or hand-to-neck movements-is restored with minimal functional impairment and without the risk of excessive external rotation.
⦁ Still further objective of the invention is to simplify the surgical process by integrating the measurement of rotational correction into the osteotomy procedure, reducing the need for subjective clinical assessment and reliance on intraoperative judgment.
⦁ By achieving the above objectives, the invention aims to improve the accuracy, safety, and effectiveness of humeral rotational osteotomies in children with BPBI, leading to better long-term functional outcomes and greater parental satisfaction.

SUMMARY OF THE INVENTION:

⦁ The following presents a simplified summary of the invention in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the present invention. It is not intended to identify the key/critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some concept of the invention in a simplified form as a prelude to a more detailed description of the invention presented later.
⦁ The present invention relates to a surgical device designed to improve the accuracy and precision of humeral rotational osteotomies in pediatric patients with residual Brachial Plexus Birth Injuries (BPBI). Specifically, the invention provides an innovative jig system that enables surgeons to measure and achieve precise rotational correction during humeral osteotomy procedures, overcoming the limitations and inaccuracies of traditional techniques.
The device consists of three main components:
⦁ Compression Plate: A three-holed plate that is placed on the proximal bone segment, providing a stable base for fixation and attachment of the jig. The plate also allows for the passage of K-wires through specific sleeves for accurate alignment.
⦁ Central Pillar: This component connects the compression plate to the Goniometric-Rotational (GR) Guide. It features adjustable height settings to accommodate different bone diameters, allowing the device to be tailored to the specific anatomy of the patient. The central pillar ensures that K-wires pass through the center of the humerus, ensuring precise rotational correction.
⦁ Goniometric-Rotational (GR) Guide: The GR guide features slots and sleeves at precise angular increments (5° to 45°) for passing K-wires, enabling accurate measurement of the desired rotational correction. This guide facilitates the alignment of the bone fragments at the correct angle, based on preoperative measurements and intraoperative assessments.
⦁ Together, these components work in harmony to allow for accurate measurement and real-time adjustment of the humeral rotation, eliminating common sources of error in traditional methods. The device ensures that the osteotomy is performed with the correct rotational alignment, preventing complications such as over-correction or under-correction, which can lead to functional impairments and dissatisfaction with the surgical outcome.
⦁ The device is particularly beneficial for pediatric patients with BPBI who require humeral rotational osteotomies to correct internal rotation deformities. By enabling precise correction of these deformities, the device helps restore functional range of motion-such as hand-to-mouth and hand-to-neck movements-thereby improving the child's ability to perform daily activities. Additionally, the device minimizes the risk of injury to neurovascular structures and reduces the need for excessive surgical exposure, making the procedure safer and more efficient.
⦁ In summary, the invention provides a reliable, standardized method for achieving precise rotational correction during humeral osteotomy, resulting in better functional outcomes, reduced risk of complications, and enhanced patient and parental satisfaction.


DRAWINGS OF THE INVENTION:

The invention shall be described in further detail below under reference to the
accompanying drawings, in which:

⦁ Figure1. illustrates a components of the device

⦁ Figure 2. illustrates a software axial picture of the Orthokids Precise Derotation Jig placed on the humerus.
⦁ Figure 3. illustrates a height of the central pillar determined by the axial diameter of humerus.
⦁ Figure 4. illustrates a dimension of the Jig component.
⦁ Figure 5.1. illustrates a Placement of Jig over bone, two screws placed in proximal two holes, k-wire passed in the third hole through sleeve from the central pillar.


⦁ Fig: 5.2 Second k-wire is placed in the distal fragment at desired angle of de-rotation through Goniometric rotation device.

⦁ Figure: 5.3 Placement of wires will be at precise desired angle of de-rotation.

⦁ Figure: 5.4 Once the osteotomy is performed, the jig is removed and distal fragment is rotated so that both wires lie parallel and plate fixation is completed.

DETAILED DESCRIPTION OF THE INVENTION:

[0021] The following description is provided to assist in a comprehensive understanding of exemplary embodiments of the invention. It includes various specific details to assist in that understanding, but these are to be regarded as merely exemplary.
[0022] Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope of the invention. In addition, descriptions of well-known functions and constructions are omitted for clarity and conciseness.
[0023] The terms and words used in the following description and claims are not
limited to the bibliographical meanings, but, are merely used by the inventor to enable a clear and consistent understanding of the invention.
[0024] Accordingly, it should be apparent to those skilled in the art that the following description of exemplary embodiments of the present invention are provided for illustration purpose only and not for the purpose of limiting the invention as defined by
the appended claims and their equivalents.
[0025] It is to be understood that the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.
[0026] Features that are described and/or illustrated with respect to one embodiment, aspects or implementations may be used in the same way or in a similar way in one or
more other embodiments and/or in combination with or instead of the features of the other embodiments, aspects or implementations.
[0027] It should be emphasized that the term "comprises/comprising" when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other
features, integers, steps, components or groups thereof.
[0028] It is also understood that the terms "collecting", "sieving", "washing", "grinding", "drying", "extracting", "concentrating", used herein intend to cover all kinds of conventional methods used for the said purpose carried out at room temperature unless specified particularly herein. The term "herbal composition", as
used herein, intends to cover herbal composition useful in managing neurological disorders.
[0029] As used herein, "treatment", "management" and "treating" and the like generally mean obtaining a desired pharmacological and physiological effect. The effect may be prophylactic in terms of preventing or partially preventing a disease, symptom or condition thereof and/or may be therapeutic in terms of a partial or complete cure of a disease, condition, symptom or adverse effect attributed to the disease. The term "treatment" as used herein covers any treatment of a disease in a mammal, particularly
a human, an animal, and includes: (a) preventing the disease from occurring in a subject; (b) inhibiting the disease, i.e., arresting its development; or relieving the disease, i.e., causing regression of the disease and/or its symptoms or conditions.

[0030] In an embodiment, the present invention provides a surgical device specifically designed for performing precise rotational osteotomies in pediatric patients with residual Brachial Plexus Birth Injuries (BPBI). This device, referred to as the Orthokids Precise De-rotation Jig, aims to address the challenges associated with current techniques used for measuring and correcting rotational deformities of the humerus. By utilizing a standardized, precise mechanism for determining and achieving the correct amount of rotation, this device improves surgical accuracy, reduces the risk of over-correction or under-correction, and enhances functional outcomes in pediatric patients.

Components of the Device: (Figure 1,2,3)

The Orthokids Precise De-rotation Jig consists of three main components, each carefully engineered to work together to achieve accurate rotational correction during humeral osteotomy procedures:

⦁ Compression Plate:

The compression plate is a three-holed plate with a shape and structure similar to that of a Dynamic Compression Plate (DCP), designed to rest on the proximal bone segment of the humerus. The plate features two screw holes for fixation to the proximal fragment and a third hole used for the attachment of the jig. A K-wire can be passed through this hole via a sleeve to facilitate precise alignment. The plate ensures stable fixation of the proximal bone segment while the osteotomy is performed, and it provides a reliable anchor for the rotational guide system.

⦁ Central Pillar:

The central pillar connects the compression plate to the Goniometric-Rotational (GR) Guide, serving as a bridge to provide vertical adjustment of the GR guide. The pillar allows for three-level adjustment to accommodate different bone diameters, ensuring that the device can be adapted to the anatomy of the patient. The standard height of the central pillar is 62.5 mm. The central proximal hole in the pillar aligns with the third hole of the compression plate, and it ensures that the K-wire passed through the GR guide aligns centrally within the bone during the procedure. The pillar provides the necessary height adjustments to ensure that the K-wire passes through the center of the humerus in cross-section, achieving optimal rotation when the distal segment is derotated.

⦁ Goniometric-Rotational (GR) Guide:

The GR guide plays a key role in measuring and guiding the precise rotational correction. The guide has a central hole that corresponds to the third hole of the compression plate, through which a K-wire can be passed via a sleeve. This central hole is positioned so that the K-wire aligns accurately with the bone during the osteotomy procedure. On either side of the central hole, the GR guide has slots at angular increments from 5° to 45° in 5° intervals, allowing for precise measurement and adjustment of the desired rotational correction. The gap between the center hole of the GR guide and the proximal central hole of the central pillar is 16.5 mm, corresponding to the distance between the proximal and distal screw holes of the compression plate, ensuring consistent alignment.

Development of the Device (Figures-2,3)
To ensure that the device accommodates the varying anatomy of pediatric patients, the height of the central pillar was determined based on the diameter of the humerus, specifically the diameter of the humerus at the proposed site of the osteotomy. A study of 50 children with BPBI revealed that the mean diameter of the humerus was 14 mm in children younger than 10 years and 18 mm in those older than 10 years. These measurements guided the determination of the appropriate height of the central pillar, ensuring that the K-wire, when passed through the GR guide, aligns centrally within the humerus to achieve accurate rotational correction. The system is adaptable to varying humeral diameters, making it suitable for a wide range of pediatric patients.

Surgical Procedure:

The "Orthokids Precise De-rotation Jig" is used in conjunction with standard surgical techniques for performing humeral rotational osteotomies. The device can be used with either a proximal or distal approach, depending on the nature of the deformity being addressed.

⦁ Proximal - Deltopectoral approach: This approach is commonly taken when a varus osteotomy (in children with abduction contracture) is planned along with the de-rotation osteotomy. The proximal humerus is approached through delto-pectoral approach; subperiosteal dissection is done to expose the shaft proximal to deltoid insertion. Retraction should be gentle so as not to injure the radial nerve posteriorly.

The steps with the jig are as follows: (Figure 5)

⦁ Orthokids Precise De-rotation jig is placed on the shaft. Two screws of appropriate size inserted in the DCP (Dynamic compression plate) segment. After placing a sleeve in the central hole, a bicortical K-wire is inserted. The screw size and k-wire extent are confirmed under image intensifier.
⦁ The 2nd wire is inserted via the sleeve of the goniometric segment at the desired angle and the osteotomy site is marked on the shaft.
⦁ The screws are then removed. K-wires are cut flush to the sleeve surface. The plate-jig apparatus is now removed.
⦁ Periosteum is circumferentially reflected around the osteotomy site. Osteotomy is completed with a saw.
⦁ Distal segment is externally rotated to make both the wires parallel. A 6-hole DCP is placed with the wires being in the 3rd and 4th holes parallel to each other. Proximal screws fixation is completed with the pre-measured screws. K-wire is removed from the proximal segment, drilled and third screw is inserted. Plate is held flush to the plate with bone-plate holding forceps. One distal screw is inserted.
⦁ Clinically the arm position and the rotational range are checked after removing the bone-plate holding forceps. The arm should have a free passive range to be able to touch mid-line and the desired external rotation. Final screw fixation is completed with 3 screws each in either side of the osteotomy. Routine wound closure is done and an above elbow slab is applied.

⦁ Distal (medial approach): This approach is taken when only a de-rotational osteotomy is planned. Distal 1/3rd of the shaft is exposed through medial approach utilizing the interval between brachialis and triceps, keeping the ulnar nerve posteriorly along with the triceps. Shaft is subperiosteally exposed. The plate is placed on the medial humeral surface so that it would end proximal to the distal humeral flare. The osteotomy and fixation is completed in a similar manner to as mentioned above. Post operatively the arm is immobilized in either a long arm cast or shoulder spica depending on whether any concomitant procedure was performed along with it. The medial approach is cosmetically appealing since it has an inconspicuous scar.

Advantages of the Device
The Orthokids Precise De-rotation Jig offers several key advantages over existing methods:
⦁ Accuracy and Precision:
The device allows for accurate and consistent measurement of rotational angles, eliminating errors caused by subjective clinical assessment. The goniometric-rotational guide offers precise control over the angle of correction, ensuring the humeral rotation is corrected to the desired degree.
⦁ Safety:
By improving the alignment of K-wires and reducing the need for external wire placement, the device minimizes the risk of iatrogenic injury to neurovascular structures, particularly the radial and ulnar nerves.

⦁ Adaptability:
The device is designed to be adjustable based on the individual patient's anatomy, ensuring a tailored approach to each surgery. The height of the central pillar can be adjusted to match the diameter of the patient's humerus, allowing for proper alignment during rotation.
⦁ Reduced Surgical Complexity:
The device simplifies the surgical process by reducing reliance on intraoperative "eye-balling" and guesswork. The precise mechanism ensures that the rotation is corrected accurately, reducing the chances of over- or under-correction.
⦁ Improved Functional Outcomes:
By achieving precise rotational correction, the device helps restore essential functions such as hand-to-mouth and hand-to-neck movements, improving the patient's ability to perform daily activities. This, in turn, leads to better long-term functional outcomes and greater parental satisfaction.

The Orthokids Precise De-rotation Jig provides a reliable, accurate, and safe method for performing humeral rotational osteotomies in pediatric patients with BPBI. It eliminates errors inherent in traditional methods, improves surgical precision, and enhances the likelihood of achieving functional range of motion postoperatively. By addressing the challenges of rotational alignment in humeral osteotomy procedures, this device represents a significant advancement in pediatric orthopedic surgery.
, Claims:CLAIMS:
We claim:
1.
An orthokids precise de-rotation jig for rotational osteotomies of humerus comprises of:
a)
Compression Plate, having a 3-oval holed plate (similar in profile and make to a dynamic compression plate - DCP) which rests on the proximal bone segment and two screw holes for proximal fixation are available and the 3rd hole has the jig attachment from which a k-wire can be passed via a sleeve;
b)
Central Pillar, which connects the plate component with the goniometric-rotational (GR) guide and three-level adjustment is possible to adjust the height of the GR guide depending on the bone diameter (to be measured pre-operatively in lateral humeral radiographs) and the standard height of the central pillar is 62.5 mm and central proximal hole corresponds to the 3rd hold of the plate;
c)
Goniometric-Rotational Guide (GR guide), having the central hole corresponding to the third hole of the plate; k-wire can be passed via a sleeve through the center of the screw hole and on both sides of the central hole there are slots for k-wire sleeves at increments of 5˚ till 45˚ and the Gap between center hole of the GR guide and the proximal central hole in central pillar is 16.5 mm, which matches the distance between proximal and distal screw holes;
Characterized in that
wherein the compression plate is made of a material selected from the group consisting of stainless steel, titanium alloy, and other biocompatible metals; and is configured to be compatible with dynamic compression plates (DCP);
wherein the central pillar is adjustably connected to the compression plate via a locking mechanism, ensuring that the pillar height remains fixed during use and has a standard height of 62.5 mm and can be adjusted based on the patient's humeral diameter as determined from pre-operative imaging; and
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wherein the goniometric-rotational guide allows for rotational adjustments in angular increments of 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, and 45° and further equipped with a locking mechanism to securely fix the K-wire in the desired rotational position during the procedure.
2. The orthokids precise de-rotation jig for rotational osteotomies of humerus as claimed in Claim 1, wherein the compression plate is designed to allow for placement of K-wires in both the proximal and distal humeral fragments, ensuring that the rotational correction is aligned accurately during the osteotomy procedure.
3. The orthokids precise de-rotation jig for rotational osteotomies of humerus as claimed in Claim 1, wherein the goniometric-rotational guide includes at least two angular markers to facilitate the determination of the appropriate angle of de-rotation for the humeral fragments.
4.The method for surgical procedure of an orthokids precise de-rotation jig for rotational osteotomies of humerus, comprising the steps of:
a)
Placing the jig on the humeral shaft, securing it with two screws in the Dynamic Compression Plate (DCP) segment;
b)
Inserting a bicortical K-wire through the central hole of the jig using a sleeve, and confirming the screw size and K-wire placement under image intensification;
c)
Inserting a second K-wire through the goniometric segment at the desired rotational angle, marking the osteotomy site on the shaft;
d)
Removing the screws, cutting the K-wires flush to the sleeve surface, and detaching the jig apparatus;
e)
Reflecting the periosteum circumferentially around the osteotomy site and completing the osteotomy with a saw;
f)
Externally rotating the distal humeral segment to align both K-wires parallel, placing a six-hole DCP with the K-wires in the third and fourth holes;
g)
Fixing the proximal screws using pre-measured screws, removing the K-wire from the proximal segment, drilling, and inserting a third screw;
h)
Holding the plate flush to the bone with bone-plate holding forceps and inserting one distal screw;
15
i)
Checking the arm position and rotational range clinically after removing the bone-plate holding forceps, ensuring the arm can reach the mid-line and desired external rotation; and
j)
Completing the fixation with three screws on either side of the osteotomy, followed by routine wound closure and application of an above-elbow slab.
5.
The method for surgical procedure of an orthokids precise de-rotation jig for rotational osteotomies of humerus as claimed in claim 5, wherein the surgical procedure is having two approaches:
a)
Proximal - Deltopectoral approach; and
b)
Distal (medial approach).
6.The method for surgical procedure of an orthokids precise de-rotation jig for rotational osteotomies of humerus as claimed in claim 6, wherein Proximal - Deltopectoral approach further comprising the steps of:
a)
Approaching the proximal humerus through a deltopectoral incision, exposing the humeral shaft proximal to the deltoid insertion;
b)
Performing subperiosteal dissection to fully expose the humeral shaft, ensuring adequate visibility for the osteotomy site;
c)
Gently retracting the tissues to prevent injury to the radial nerve, located posterior to the humeral shaft;
d)
Planning and performing the osteotomy in conjunction with a varus osteotomy (in cases of abduction contracture), and executing the de-rotation osteotomy as necessary for correction.
7.
The method for surgical procedure of an orthokids precise de-rotation jig for rotational osteotomies of humerus as claimed in claim 6, wherein Distal (medial approach) further comprising the steps of:
16
a)
Exposing the distal humeral shaft through a medial approach, utilizing the interval between the brachialis and triceps muscles, while ensuring that the ulnar nerve is kept posteriorly along with the triceps to avoid nerve injury;
b)
Performing subperiosteal dissection to fully expose the distal humeral shaft for osteotomy;
c)
Placing a plate on the medial surface of the humerus, ensuring that the plate ends proximal to the distal humeral flare, in preparation for fixation;
d)
Performing the de-rotational osteotomy and completing fixation in a manner similar to the procedures outlined in previous claims;
e)
Immobilizing the arm post-operatively in either a long arm cast or shoulder spica, depending on whether any additional procedures were performed, to ensure proper healing; and
f)
Achieving a cosmetically favourable outcome, as the medial approach results in an inconspicuous scar.

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