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Journal of Orthopaedics logoLink to Journal of Orthopaedics
. 2024 Feb 19;52:78–84. doi: 10.1016/j.jor.2024.02.020

Clinical results of arthroscopically-assisted lower trapezius transfer using fascia lata autograft for posterior superior irreparable rotator cuff tear

Chang Hee Baek a,, Bo Taek Kim a, Jung Gon Kim a, Seung Jin Kim a
PMCID: PMC10904162  PMID: 38435318

Abstract

Background

Different interpositional grafts have been proposed to connect between the lower trapezius tendon (LTT) to the humerus during LTT transfer. While studies often mention the successful use of Achilles tendon allograft, there is currently no literature reporting the clinical outcomes of utilizing fascia lata autograft (FLA) in LTT transfer. Therefore, the current study aims to evaluate the clinical and radiologic results of LTT using FLA for posterior superior irreparable rotator cuff tears (PSIRCTs) without arthritis.

Patient and methods

The present study constitutes a retrospective case series involving 22 patients, with a mean follow-up of 35.9 ± 15.9 months. Pain levels were gauged using the Visual Analog Scale (VAS), while shoulder function was comprehensively assessed through the Constant and ASES (American Shoulder and Elbow Society) scores. The evaluation of shoulder activities in daily living employed the ADLER (Activities of Daily Living Requiring Active External Rotation) score. Active ROM (Range of Motion) of all directions were obtained, radiologic assessments included key parameters such as AHD (Acromion Humeral Distance) and the Hamada grade. Finally, the integrity of the transferred LTT was evaluated, and a subgroup analysis was undertaken based on Tm trophicity.

Results

By the final follow-up period, VAS, Constant, ASES, and ALDER demonstrated significant improvement. Active ROM significantly improved in (FE) forward elevation to 155° ± 29°, abduction (Abd) to 140° ± 32°, external rotation (ER) at 90° Abd to 68° ± 19°, and ER at the side to 39° ± 17°. AHD and Hamada grade showed no significant arthritic progression. Tm hypertrophy group experienced superior improvements in ER compared to that of the non-hypertrophy group. Complications included re-tear (n = 2), infection (n = 1) and donor-site morbidity (n = 1).

Conclusion

The study highlighted promising clinical outcomes of LTT transfer using FLA, with no significant complications. Along with Achilles tendon allograft, FLA can be a safe and viable alternative interpositional graft choice.

Keywords: Rotator cuff, Irreparable tear, Posterior superior rotator cuff tear, Fascia lata, Tendon transfer, Lower trapezius tendon transfer

1. Introduction

Posterior superior irreparable rotator cuff tears (PSIRCTs) may find effective non-surgical management, particularly in patients at risk of surgical complications and those with decreased functional demands.1 While various surgical treatment options2 are available, joint-preserving methods should be considered for patients with PSIRCTs but without arthritis. For such cases, lower trapezius tendon (LTT) transfer has shown promising clinical outcome and remains effective even at mid-term duration.3, 4, 5, 6 In the course of the surgical procedure, it is essential to use an interpositional graft to connect between the humerus and the LTT. While studies3, 4, 5, 6, 7 often mention the successful use of Achilles tendon allograft, initially introduced by Elhassan et al.,5 concerns may persist regarding its cost, delayed healing, and infection related problem.8,9 While the autografts have the drawback of donor site morbidity, they minimize the risk of inflammatory responses and lower the risk of infection, reducing potential graft-related complications.10,11

To our knowledge, there is currently a scarcity of reports describing the usage of autografts in LTT transfer. Only one study has reported clinical outcome using the semitendinous autograft.12 However, no literature has reported outcomes of using any other autografts in LTT transfer. Therefore, current study is to evaluate the clinical and radiologic results of LTT transfer with fascia lata autograft (FLA) for PSIRCTs without arthritis. We hypothesized that LTT transfer using FLA can yield promising clinical outcomes. Additionally, our hypothesis posited that the group with teres minor (Tm) hypertrophy would exhibit a greater external rotation in comparison to the group without Tm hypertrophy.

2. Material and methods

2.1. Patients selection

We conducted a retrospective review of 26 patients who received LTT transfer utilizing FLA between May 2017 and September 2021. Indications for LTT transfer included: (1) enduring pain; (2) no response to conservative treatment; (3) minimal glenohumeral arthritis, with grade ≤2 Hamada13 classification (Fig. 1A); (4) intact or small tear in subscapularis, with grade ≤ II Lafosse14 classification; (5) poor quality in supraspinatus (SSP) and infraspinatus (ISP) muscle, categorized as Goutallier15 grades≥3 (Fig. 1B); (6) without neurologic deficit or previous infection history. PSIRCTs were defined by: (1) identification of tears in the SSP and ISP in preoperative magnetic resonance imaging (MRI); (2) severe retraction of rotator cuff, identified as Patte16 stage 3 (Fig. 1C); (3) poor muscle quality in SSP and ISP, categorized as Goutallier15 grades≥3 (Fig. 1B); (4) intraoperative findings that indicate the inability to reduce the remnant SSP and ISP tendon to their footprint. Six patients had previously undergone arthroscopic supraspinatus repair. Meeting the criteria for PSIRCTs mentioned above, they were included in the study and received the identical surgical procedure as those who underwent primary LTT transfer. Patients were excluded from the study if they exhibited unavailability for conclusive data (n = 3) and if assessment of final MRI scan was not feasible (n = 1). Finally, current study comprised a total of 22 patients (Fig. 2).

Fig. 1.

Fig. 1

Preoperative Radiograph and Magnetic Resonance Imaging (MRIs) (A) Minimal arthritis in the true anteroposterior view. (B) Poor muscle quality of the supraspinatus and infraspinatus in the Y-view. (C) Severe retraction of supraspinatus (white asterisk) in coronal view.

Fig. 2.

Fig. 2

Flowchart.

aLTT transfer, arthroscopically assisted lower trapezius tendon transfer; PSIRCTs, posterior superior irreparable rotator cuff tears; MRI, magnetic resonance imaging; SSP, supraspinatus; ISP, infraspinatus; N/A, not available; f/u, follow-up.

2.2. Surgery

All surgical procedures were conducted by a single surgeon (C·H·B) in lateral decubitus under general anesthesia. The reparability of the SSP and ISP tendons was evaluated to determine whether the remnant tendons could be reduced to their original footprint. Following the confirmation of the PSIRCTs (Fig. 3A), arthroscopically-assisted LTT transfer was carried out. After preparing the footprint, two medial-row anchors (Healix BR, DePuy Mitek, Raynham, MA) were placed in greater tuberosity.

Fig. 3.

Fig. 3

Surgical Procedure

The arthroscopic image of (A) irreparable status of supraspinatus and infraspinatus tears and (B) the final appearance after fixation of the fasia lata autograft (FLA) (white asterisk). (C) Exposure of FLA. (D) Prepared FLA. (E) Harvested lower trapezius tendon (LTT) (white asterisk). (F) Attachment of FLA (white asterisk) to LTT.

To obtain FLA, longitudinal incision was made in the lateral aspect of the ipsilateral thigh, and 15 cm × 4 cm FLA was harvested (Fig. 3C). Then, the harvested FLA was prepared by folding in half and applying No. 2 non-absorbable sutures on each edges (Fig. 3D). For the LTT harvest, an incision was made just below the spine of scapula on the back. After meticulous dissection and release of the deep fascia, the LTT was detached from the scapular spine. To avoid spinal accessory nerve injury, dissection was limited to the scapula's medial border. After achieving sufficient excursion of the LTT, #2 suture was placed in the inferior border of the LTT (Fig. 3E). Then, a small incision was made in the ISP fascia laterally to the harvested LTT to deliver FLA into subacromial space. Using Kelly Forceps, the FLA was grasped and brought into the subacromial space.

Two suture limbs of posterior Healix BR anchor (Depuy Mitek) were threaded through the residual posterior cuff muscle. These sutures were tied for side-to-side fashion with the FLA. The rest of the suture limbs of Healix BR anchors were threaded through the FLA. Secure fixation of the graft was completed with three lateral-row anchor (SwiveLock, Arthrex Inc, Naples, FL) using suture bridge technique (Fig. 3B). Lastly, the FLA was attached to the LTT in continuous locking fashion (Fig. 3F). During the attachment, the patient's upper limb was externally rotated to its maximum extent at approximately a 60° abduction angle. Finally, the arthroscopy portals and wounds of both the LTT and FLA were closed.

2.3. Postoperative management

For the initial four weeks after the surgery, patients were instructed to wear an abduction brace. They were allowed to carry out daily tasks without strict restrictions while still wearing the brace. Four weeks postoperatively, patients were no longer required to wear the abduction brace. They then commenced active-assisted range of motion (ROM) rehabilitation, gradually moving onto ROM rehabilitation in all directions. Three months postoperatively, the strengthening training began as part of the rehabilitation regimen. However, patients were advised to avoid high-intensity activities for the first six postoperative months.

3. Clinical assessment

The degrees of pain and function were assessed both pre- and postoperatively. Data obtained both demographic and clinical information. Pain was measured using VAS (Visual Analog Scale). Various standardized measurements, including Constant score and ASES (American Shoulder and Elbow Society), had been obtained. The shoulder activity level was evaluated using ALDER (Activities of Daily Living Requiring Active External Rotation), while patient's perspective on his or her clinical status was assessed using SANE (Single Assessment Numeric Evaluation). The active ROM (aROM) of the shoulder was measured in all directions using a standardized goniometer. Internal rotation (IR) was measured at the thumb position in the back. All clinical scores and aROM were assessed and recorded at each follow-up visit at outpatient clinic by physician assistant.

4. Radiologic assessment

To obtain AHD (Acromion Humeral Distance), we measured the distance between the apex of the humeral head and the lower border of the acromion in the true anterior posterior shoulder radiograph. Hamada13 grading system was used to assess the change in glenohumeral joint arthritis. Final MRI was obtained to evaluate the transferred tendon integrity (Fig. 4), following the classification established by Sugaya et al.17 In this classification, type IV and type V depict discontinuity of the tendon, where it can be defined as a re-tear. The rotator muscle quality was evaluated through the Goutallier15 grading system in the Y-view. The Tm trophicity was defined according to the definition established by Kikukawa et al.18 In the Y- view, a ratio of the Tm muscle area to combined ISP and Tm muscle area was calculated; the Tm hypertrophy was defined by a ratio of ≥0.288. The board-certified musculoskeletal radiologist examined the MRI scan without knowing the clinical information.

Fig. 4.

Fig. 4

Postoperative Magnetic Resonance Imaging (MRI)

Normal integrity of transferred lower trapezius tendon (white arrow) in (A) coronal-view and (B) axial-view of MRI scan.

5. Statistical analysis

Any statistics were conducted using IBM SPSS version 11, (Armonk, NY, USA). Paired t-tests and Wilcoxon signed rank tests were employed for continuous data, while Chi-square and Fisher exact tests were utilized for categorical data. The study assessed the interobserver reliability of the radiologic parameters by determining ICC (intraclass correlation coefficient). The statistical significance threshold was established as P < 0.05.

6. Results

Table 1 provides a summary of patient demographic information. The average age was 63.5 ± 4.9 years, with a range of 51–71 years. The average follow-up period was 35.9 ± 15.9 months, with a range of 24–64 months. Clinical results are summarized in Table 2. The VAS, Constant, ASES, and ALDER score showed significant improvement (all, P < 0.001). Final aROM achieved significant improvement in all direction except IR; final FE (Forward elevation) improved to 155° ± 29° (P < 0.001), Abd (Abduction) to 140° ± 32° (P < 0.001), ER (External rotation) at 90° Abd to 68° ± 19° (P < 0.001), and ER at side to 39° ± 17° (P < 0.001) (Fig. 5). Regarding the patient's satisfaction, SANE score significantly increased from 49.2 ± 13.2 to 78.6 ± 15.4 (P < 0.001). An excellent ICC was obtained between the two examiners (AHDpre = 0.991, P < 0.001; AHDfinal = 0.995, P < 0.001; Hamadapre = 0.826, P < 0.001; Hamadafinal = 0.909, P < 0.001). There was no significant progression of arthritis by final follow-up (AHDpre 7.9 mm ± 2.5 mm vs AHDfinal 7.5 mm ± 2.1 mm, P = .233; Hamadapre 1.2 ± 0.4 vs Hamadafinal 1.3 ± 0.5, P = .406).

Table 1.

Demographic and clinical characteristics of study subjects.

Variables Value
Sex, Male/Female, n (%) 17 (77.2)/5 (22.7)
Age (year), mean ± SD (range) 63.5 ± 4.9 (51–71)
Follow-up (month), mean ± SD (range) 35.9 ± 15.9 (24–64)
Dominant arm involvement, n (%) 19 (86.3)
BMI (kg/m2), mean ± SD 23.8 ± 2.1
HTN, n (%) 9 (40.9)
DM, n (%) 2 (9.0)
Smoker, n (%) 4 (18.1)
Symptom duration (month), ±SD (range) 10.8 ± 2.3 (7–15)
Osteoporosis, n (%) 0 (0)
Preoperative Pseudoparalysis, n (%) 2 (9.0)
Prior rotator cuff repair surgery, n (%) 6 (27.2)
Repairable Concomitant SSC tear, n (%) 2 (9.0)
Preoperative Hamada Grade, n (%)
 Grade 1 19 (86.3)
 Grade 2 3 (13.6)
Preoperative SSC FI grade, n (%)
 Grade 0 or 1 15 (68.1)
 Grade 2 7 (31.8)
Preoperative SSP FI grade, n (%)
 Grade 3 8 (36.3)
 Grade 4 14 (63.6)
Preoperative ISP FI grade, n (%)
 Grade 3 4 (18.1)
 Grade 4 18 (81.8)
Preoperative Tm FI grade, n (%)
 Grade 0 or 1 11 (50.0)
 Grade 2 9 (40.9)
 Grade 3 2 (9.1)

SD, standard deviation; BMI, body mass index; HTN, hypertension; DM, diabetes mellitus; SSC, subscapularis; SSP, supraspinatus; ISP, infraspinatus; Tm, teres minor; FI, fatty infiltration.

Table 2.

Comparison between preoperative and final clinical and radiologic outcomes.

Variables Preoperative Final follow-up P value
VAS pain score 4.3 ± 1.4 1.4 ± 0.7 <0.001a
Constant score 51.5 ± 13.2 71.3 ± 13.1 <0.001a
ASES score 54.8 ± 14.5 76.5 ± 15.0 <0.001a
ALDER score 17.1 ± 6.2 25.1 ± 5.2 <0.001a
SANE score 49.2 ± 13.2 78.6 ± 15.4 <0.001a
Active ROM (degree)
 FE (°) 126 ± 39 155 ± 29 <0.001a
 ABD (°) 110 ± 38 140 ± 32 <0.001a
 ER at 90° ABD (°) 43 ± 20 68 ± 19 <0.001a
 ER at side (°) 26 ± 15 39 ± 17 <0.001a
 IR at back b 6.2 ± 1.5 6.6 ± 1.3 0.119
AHD (mm) 7.9 ± 2.5 7.5 ± 2.1 0.233
Hamada grade 1.2 ± 0.4 1.3 ± 0.5 0.406

VAS, visual analog scale; ASES, American Shoulder and Elbow Surgeons; ADLER, activities of daily living that require active external rotation; SANE, Single Assessment Numeric Evaluation; ROM, range of motion; FE, forward elevation; ABD, abduction; ER, external rotation; IR, internal rotation; AHD, acromiohumeral distance. Unless otherwise noted, values are mean ± standard deviation.

a

The significant P value is below .05.

b

Internal rotation was measured as the level that could be reached by the thumb; 0, greater trochanter; 2, buttock; 4, lumbosacral junction; 6, L3; 8, T12; and 10, T7.

Fig. 5.

Fig. 5

Clinical Photographs:

Preoperatively, the right shoulder exhibits restricted (A) forward elevation and (B) external rotation. Postoperatively, the right shoulder shows improved range of motion for (C) forward elevation and (D) external rotation.

The subgroup analysis is shown in Table 3. Preoperative demographic characteristic between Tm hypertrophy and non-hypertrophy group showed no significant differences. Irrespective of Tm trophicity, significant improvement was observed in pain relief and various clinical scores, including Constant, ASES, and ALDER. Moreover, there were no statistically significant differences identified between Tm hypertrophy group and Tm non-hypertrophy group upon comparison. However, in the comparison of aROM, the group with Tm hypertrophy demonstrated significantly greater improvements in ER at 90° Abd and ER at the side, with P = .047 and P = .042, respectively. Neither group exhibited statistically significant differences in final AHD and Hamada grade, with P = .901 and P = .083, respectively.

Table 3.

Comparison of preoperative and final clinical outcome for trophicity of teres minor.

Tm Trophicity
Variables Hypertrophy (n = 14) Non-Hypertrophy (n = 8) P-value
VAS pain score
 Preoperative 4.0 ± 1.2 5.0 ± 1.3 0.117
 Final 1.2 ± 0.7 1.6 ± 0.7 0.308
P-value <0.001a <0.001a
Constant score
 Preoperative 52.0 ± 12.8 50.5 ± 14.5 0.796
 Final 74.0 ± 13.6 66.6 ± 11.4 0.207
 P-value <0.001a 0.002a
ASES score
 Preoperative 55.2 ± 14.1 54.1 ± 16.1 0.862
 Final 80.5 ± 15.7 69.3 ± 11.2 0.093
 P-value <0.001a <0.001a
ALDER score
 Preoperative 18.7 ± 5.7 14.2 ± 6.1 0.099
 Final 26.0 ± 5.9 23.8 ± 3.5 0.387
 P-value <0.001a <0.001a
SANE score
 Preoperative 51.0 ± 13.0 46.1 ± 13.7 0.419
 Final 82.2 ± 17.5 72.5 ± 9.0 0.161
 P-value <0.001a 0.001a
Active ROM (degree)
FE (°)
 Preoperative 131 ± 37 117 ± 43 0.422
 Final 160 ± 32 147 ± 22 0.352
 P-value 0.013a 0.046a
ABD (°)
 Preoperative 115 ± 37 103 ± 43 0.470
 Final 142 ± 37 136 ± 23 0.660
 P-value 0.004a 0.048a
ER at 90° ABD (°)
 Preoperative 46 ± 17 39 ± 24 0.398
 Final 75 ± 16 58 ± 21 0.047a
 P-value <0.001a 0.035a
ER at side (°)
 Preoperative 28 ± 14 21 ± 18 0.333
 Final 49 ± 12 37 ± 14 0.042a
P-value <0.001a 0.031a
IR at back b
 Preoperative 6.3 ± 1.2 6.0 ± 1.9 0.606
 Final 6.9 ± 1.2 6.1 ± 1.3 0.166
 P-value 0.120 0.732
AHD (mm)
 Preoperative 8.2 ± 2.5 7.4 ± 2.6 0.453
 Final 7.5 ± 1.5 7.4 ± 3.0 0.901
 P-value 0.188 0.840
Hamada grade
 Preoperative 1.1 ± 0.3 1.3 ± 0.5 0.231
 Final 1.2 ± 0.3 1.5 ± 0.6 0.083
 P-value 0.818 0.197

VAS, visual analog scale; ASES, American Shoulder and Elbow Surgeons; ADLER, activities of daily living that require active external rotation; SANE, Single Assessment Numeric Evaluation; ROM, range of motion; FE, forward elevation; ABD, abduction; ER, external rotation; IR, internal rotation; AHD, acromiohumeral distance. Unless otherwise noted, values are mean ± standard deviation; Tm, Teres minor.

a

The significant P value is below .05.

b

Internal rotation was measured as the level that could be reached by the thumb; 0, greater trochanter; 2, buttock; 4, lumbosacral junction; 6, L3; 8, T12; and 10, T7.

7. Complications

Out of the 22 patients, two patients (9.1%) experienced a re-tear. One patient had converted to RSA (reverse total shoulder arthroplasty) because of pain, and the other was treated conservatively with strength rehabilitation exercises. One patient (4.5%) developed an early postoperative infection at 4 weeks, treated successfully with arthroscopic debridement, irrigation, and antibiotics. The surgical procedure preserved the graft, as the infection was confined to intraarticular and subacromial spaces. One patient (4.5%) reported consistent discomfort at the donor site, which was managed conservatively. No nerve-related complications were reported.

8. Discussion

When Elhassan et al.5 first introduced an LTT transfer with an Achilles tendon allograft, the majority of aLTT transfers have incorporated the use of Achilles tendon allografts as an interpositional graft. The current study highlights the promising clinical results of LTT transfer using FLA in patients with PSIRCTs but without arthritis. Our results align closely with those of a recent systematic review,19 including seven studies (six with Achilles tendon allograft and one with semitendinous autograft) and 159 patients who underwent LTT transfer. The systematic review showed significant postoperative functional score improvements in all studies, with consistent gains in FE and ER, ranging from 10° to 66° and 11°–63°, respectively. In current study, both the AHD and the Hamada grade did not show significant arthritic progression, which is consistent with short-term clinical results of LTT transfer reported by various authors.4,7,12,20

The use of Achilles tendon allograft offers advantages, including broad accessibility, elimination of the need for donor site harvest, and a reduction in surgical time. However, drawbacks still persist, encompassing cost implications, issues related to infections, graft rejection, and delayed healing.8,9 Furthermore, allografts, in general, are known to exhibit a higher frequency of surgical complications and revisions in comparison to autografts.21 To address these concerns, we've integrated FLA to minimize inflammatory responses and promote healing, aiming to reduce potential complications associated with allografts.10,11 In current study, one case of infection (4.5%) was observed. Nevertheless, drawback of using autograft is the potential for donor-site morbidity. In current study, one patient (4.5%) reported persistent discomfort at the donor site. However, FLA remains a viable option, as associated pain is usually temporary, and patients often accept new symptoms given the improvement in shoulder function.22 Yet, further study is required to compare the effectiveness of different types of interpositional grafts.

Tm muscle, the smallest among the rotator cuff, is often neglected but holds importance emphasized in several studies. When atrophic or absent, Tm muscle may significantly compromise shoulder function in patients with IRCTs.23 Furthermore, Tm serves as an independent predictor of patient-reported outcomes following RTSA.24 In the previous study3 of 36 patients with LTT transfer using Achilles tendon allograft for the mid-term duration, a better improvement in ER in the Tm hypertrophy group was observed compared to the non-hypertrophy group. Similar findings are observed in current study. These findings are also consistent with the study conducted by Kikukawa et al.,18,25 emphasizing that compensatory Tm hypertrophy exhibits an increase in strength and improvement in ER compared to normal or atrophic Tm. However, our findings contrast with those of other clinical studies, as they identified no association between fatty atrophy of Tm muscle and clinical outcomes.6,26 The variance in results underscores the necessity for a more comprehensive understanding of how Tm trophicity influences shoulder function and clinical outcomes.

There are several limitations in the present study. Firstly, the study is conducted at a single center and possesses a retrospective nature. To enhance the generalizability of the findings, studies involving multiple centers should be warranted. Secondly, there is small number of patients enrolled in the study. Thirdly, the utilization of FLA may not be suitable for all patients. Harvesting a sufficiently long and thick area of FLA becomes challenging in individuals who are relatively short and light-weighted. Fourthly, this study didn't compare FLA with any other interpositional grafts. Future studies are needed to compare different interpositional grafts in LTT procedures.

9. Conclusion

The current study underscored improvement in clinical results and aROM after aLTT transfer using FLA for PSIRCTs without arthritis. Two cases of re-tear were observed, with one requiring conversion to RTSA and the other managed conservatively. The FLA can be a viable option as an interpositional graft during aLTT transfer, addressing potential risks associated with allograft usage.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

IRB information

Approved by the Institutional Review Board (No. P01-202311-01-016).

Funding statement

Regarding the manuscript “Clinical Results of Arthroscopically-Assisted Lower Trapezius Transfer Using Fascia Lata Autograft for Posterior Superior Irreparable Rotator Cuff Tear” as submitted to the Journal of Orthopedics, collectively declares that there was no funding received to perform any part of this work.

Guardian/patient's consent

Regarding the manuscript “Clinical Results of Arthroscopically-Assisted Lower Trapezius Transfer Using Fascia Lata Autograft for Posterior Superior Irreparable Rotator Cuff Tear” as submitted to the Journal of Orthopedics, collectively declares that the requirement for informed consent was waived owing to the retrospective design of the study and the lack of additional harm to the patients.

Ethical statement

Institutional review board approval was obtained; Institutional Review Board (P01-202311-01-016). The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

CRediT authorship contribution statement

Chang Hee Baek: conceptualization, investigation, methodology, validation, project administration, resources, supervision, validation, writing original draft, review/editing final draft.

Bo Taek Kim: conceptualization, data curation, formal analysis, investigation, validation, methodology, validation, writing original draft, review/editing final draft.

Jung Gon Kim: conceptualization, data curation, formal analysis, investigation, methodology, validation, review/editing final draft.

Seung Jin Kim: data curation, formal analysis, investigation, methodology

Declaration of competing interest

None.

Acknowledgment

The authors would like to express gratitude to Seung Hak Choi for help of collecting clinical data.

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