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 Table of Contents  
CASE SERIES
Year : 2021  |  Volume : 13  |  Issue : 2  |  Page : 163-168

A clinical study of the management of fracture shaft of clavicle by different modalities


1 Department of Orthopedic Surgery, Central Hospital Dhori, CCL, Bokaro, Jharkhand, India
2 Department of Orthopaedic Surgery, North DMC Medical College and Hindu Rao Hospital, Malkaganj, Delhi-07, India

Date of Submission05-May-2020
Date of Acceptance11-Apr-2021
Date of Web Publication27-Dec-2021

Correspondence Address:
Dr. Naveen Kumar Singh
Ward 07, Department of Orthopaedic Surgery, North DMC Medical College and Hindu Rao Hospital, Malkaganj, Delhi - 110 007
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jotr.jotr_33_20

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  Abstract 


Background: There are multiple modalities to treat clavicle fracture in patients. Both conservative and surgical management are possible and surgen must choose the most appropriate management modality according to biological age, functional demands and type of lesion. Here, we are doing a study of treating clavicle fracture by various modalities and comparing its functional outcome. Aims: The aim of the study is to show the results of management of displaced mid shaft of clavicle by different modalities in terms of: (a) time of union of fracture, (b) functional outcome, and (c) complications. Settings and Design: This was a prospective study with total sample size of 36 consecutively reporting participants in outpatient department as well as in emergency department. Materials and Methods: Study participant was systematically and randomly allocated into three groups of 12 each, Group 1 (TENS), Group 2 (Plating), and Group 3 (Conservative). Patients were randomized into operative (TENS), operative (Plating), and Conservative in a ratio 1:1:1. Statistical Analysis Used: The comparison of normally distributed continuous variables between the groups was performed using Student's t-test. Nominal categorical data between the groups were compared using Chi-square test. For all statistical tests, P < 0.05 was taken to indicate a significant difference. Results: Comparison of normally distributed continuous variables between the groups was performed using Student's t-test. Groups were compared using Chi-square test. For all statistical tests, P < 0.05 was taken to indicate a significant difference. Displaced mid shaft fracture managed by operative manoeuvre either by TENS or Plating shows excellent result in 50% of cases whereas in non operative group excellent result seen only in 25% of cases. Conclusion: Excellent functional outcome is seen in majority of patients treated operatively and those patients are functionally more satisfied when it comes to complications rate.

Keywords: Clavicle fracture, comparative study, functional outcome


How to cite this article:
Ahmad S, Singh NK. A clinical study of the management of fracture shaft of clavicle by different modalities. J Orthop Traumatol Rehabil 2021;13:163-8

How to cite this URL:
Ahmad S, Singh NK. A clinical study of the management of fracture shaft of clavicle by different modalities. J Orthop Traumatol Rehabil [serial online] 2021 [cited 2022 Jan 26];13:163-8. Available from: https://www.jotr.in/text.asp?2021/13/2/163/333560




  Introduction Top


Clavicle fractures are common injury especially in young, active individuals either by road traffic accident (RTA) or by sports activities where high-speed collisions are very frequent. They count for approximately 2.6% of all fractures. The majority of clavicle fractures occur in midshaft of the bone where the typical compressive forces applied to the shoulder and the narrow cross-section of the bone combine, and result in bone failure. Older studies suggested that a fracture of the shaft of clavicle, even when significantly displaced, was an essentially begin injury with an inherently good prognosis when treated on operatively. In 1960 a landmark, study Neer reported nonunion in only 3 of 2235 patients which middle-third fractures of the clavicle treated by sling or figure of eight bandage. Rowe showed an overall incidence of nonunion of 0.8% in 566 clavicle fractures treated in a similar fashion. Thus what was thought to be the most serious complication of clavicle fracture– nonunion– appeared to be extremely rare. Furthermore, malunion of clavicle was described as being of radiographic interest only, with little or no functional consequences. This thinking dominated the approach to clavicle for decades.[1],[2],[3],[4]

The modalities for the management of fracture of midshaft clavicle are nonoperative (Conservative) and operative (plate fixation and intramedullary fixation).

Despite the high frequency of clavicle fracture, the choice of proper treatment is still a challenge for the orthopedic surgeon. With this review, we want to focus the attention of basic epidemiology, anatomy, classification, evaluation, and management of surgical treatments in relationship with the gravity of injuries. Both conservative and surgical management are possible, and surgeons must choose the most appropriate management modality according to the biologic age, functional demand, and type of lesion. Criteria for conservative or surgical management are not clearly established; therefore, the appropriate management of these fractures should consider several factors, mainly the patient's biologic age, functional demands, and the type of lesion.[5]

There has been increasing evidence that the outcome of nonoperatively treated especially displaced or shortened midshaft fractures is not optimal as was once thought. In 1997, Hill et al. were the first to use patient-oriented outcome measures to examine 66 consecutive patients with displaced midshaft clavicle fractures, and they found that an unsatisfactory outcome in 31% as well as nonunion rate of 15% good results with a high union rate and a low complication rate have been reported from a variety of techniques for primary fixation of displaced fractures of the clavicle. Zlowodzki et al. meta-analysis showed a relative risk reduction of 86% for nonunion with primary plate fixation compared with nonoperative treatment.[6],[7]

The proponents of early fixation of fresh clavicular fractures to prevent complications such as malunion and nonunion emphasize the value of accurate reduction and rigid fixation in affording quick pain relief and promoting early functional recovery.[7]

Recent advances in plate technology have added to the treatment choices for midshaft clavicle fractures. The development of locking plate technology has specific advantages for clavicular fixation. Especially, having the plate and screws as a single construct may enhance the ability of the plate to resist the large inferiorly directed torque on the outer segment and therefore may limit the potential for plate pull out. Alternatively, clavicular plates are now available in an S-shape, to better follow the axial course of the clavicle when they are placed in a superior position.[8] The functional outcome was assessed by Constant-Murley score.[9]

Aims and objective

The aims and objective of the study are to show the results of management of fracture shaft of clavicle by different modalities in terms of: (a) time of union of fracture, (b) functional outcome, and (c) complications.


  Materials and Methods Top


Source of data

The study was conducted at Department of Orthopaedics, Hindu Rao Hospital, Delhi, between March, 2018 and May, 2019. All patients with fracture displaced midshaft clavicle will be taken into the study whether treated conservatively or operatively.

Study of design

Type of study

This is a prospective study.

Sample size

Sample size of total 36 patients consecutively coming to outpatient department (OPD) as well as emergency department. Study participant was systematically and randomly allocated into three groups of 12 each, Group 1 (TENS), Group 2 (Plating), and Group 3 (Conservative).

Sampling method

Patients were randomized into operative (TENS), operative (Plating), and Conservative in a ratio 1:1:1.

Inclusion criteria

All patients within the age group of 16–50 years with fracture of shaft clavicle were included in the study.

All have displaced midshaft clavicular fractures. None of them had any medical contraindication to general anesthesia.

Exclusion criteria

Patient with age less than 16 years or more than 50 years with fracture shaft of clavicle are were excluded in the study. Open fracture, pathological fracture, bilateral fracture and fracture clavicle with neurovascular deficit were also excluded.

Statistical analysis

All analysis is done using software SPSS (Statistical Package for the Social Sciences) 17.0 version. Continuous variables were presented as mean ± standard deviation or median if the data were unevenly distributed. Categorical variables were expressed as frequencies and percentages. The comparison of normally distributed continuous variables between the groups was performed using Student's t-test. Nominal categorical data between the groups were compared using Chi-square test. For all statistical tests, P < 0.05 was taken to indicate a significant difference. Microsoft excel was used to draw tables, bar and pie diagrams, and for the statistical analysis.

Operative treatment

Immediately after admission, the patients were administered appropriate dose of analgesic to relieve pain and injured clavicle was immobilized in figure of eight brace.

Preoperative preparation of patients includes as follows: (a) patients were kept fasting for 6 house before surgery, (b) a written informed consent for surgery was taken, (c) ipsilateral axilla, shoulder, and chest were prepared, and (d) a systematic antibiotic usually injection ceftriaxone 1 g intravenously was administered 30 min before surgery to all patients.

Technique of plate and screw fixation

Patient kept in supine position on OT table with one folded towel in between the scapula. Entire upper limb from the base of neck to hand were prepared and draped. About 7–9 cm, incision was made in the anterior aspect centering of clavicle over the fracture site. The skin subcutaneous tissue and platysma were divided without undermining the edges. The overlying fascia and periosteum were divided next. The osseous ends were freed from surrounding tissues. Minimal soft tissue and periosteum dissection were done. Fracture fragments were reduced and plate was applied over the superior aspect of the clavicle. At the junction of the medial and middle third of the clavicle, the inferior surface is exposed so that a protective instrument can be inserted during drilling to prevent injury to neurovascular structure underneath it. The plate was fixed to medial and lateral fragment with 3.5 mm cortical screw, and at least three screws in medial and lateral fragment were applied. Wound was closed in layers after ensuring meticulous hemostasis and sterile dressing was applied.

Technique for intramedullary fixation

The goal of treatment for these types of fractures of the shaft of the clavicle was to achieve anatomical reduction as much as possible and then splint them with intramedullary fixation. The shape of the nail and the shape of the bone maintain alignment and rotation. Shortening is prevented by bone contact. Stiff pins or thick K-wires were avoided as the limited diameter of the intramedullary canal of the clavicle, and its curved anatomy presents inherent difficulties during insertion and stabilization of the fracture. Shoulder manipulation was done using in-line traction, and an external rotation movement was given to reduce the fracture. Pointed reduction clamps were used either percutaneously or through small stab incisions. In cases where closed reduction was not possible, a small incision directly over the fracture site made to perform a limited open reduction. Using image intensifier, the entry point was obtained during a 2.5 mm drill bit in the anterior cortex of the medial clavicle 1.5–2.0 cm lateral to the sternoclavicular joint. The entry point was enlarged with a small awl in a lateral direction to allow for ease of insertion. A 2.0–3.5 mm titanium elastic nail designed for intramedullary fixation was inserted then with the aid of the universal T-handle chuck. The nail was manually inserted with oscillating movements under image intensifier control and advanced to the fracture site. The tip of the nail had a slight curve, which helped in passing into the lateral fragment. The tip of the nail was advanced as far lateral as possible without perforating the cortex. The medial end of the nail was then cut and buried subcutaneously or slightly proud depending on surgeon preference.

Postoperative care

Postoperatively, antibiotics were continued for 5 days. Analgesic and tranquilizers were given according to the needs of the patient. The operated upper limbs were immobilized in an arm pouch. Check X-ray was taken to the study the alignment of fracture fragments. The wounds were inspected at 3rd or 4th postoperative day. Patients were discharged with the arm pouch.

Rehabilitation protocol

(a) Day 1st to 2nd week, limb was immobilized in a sling with shoulder held in adduction and internal rotation. Shoulder was immobilized with 90° of elbow flexion. (b) At 2nd to 4th week, after suture removal gentle pendulum exercises to the shoulder were permitted as tolerated. (c) At 4th to 6th week, gentle active range of motion of the shoulder was allowed. Abduction was limited to 90°. (d) At 6th to 8th week, active to active-assistive range of motion in all planes was allowed. (e) At 8th to 12th week, isometric and isotonic exercises were prescribed to the shoulder girdle muscles.

Nonoperative treatment

Nonoperative treatment consisted of figure of eight brace application. Brace was changed every week till fracture healed. Following healing, a course of physiotherapy for strengthening was prescribed.

Rehabilitation protocol

(a) Limb was mobilized for 3 weeks in a sling with shoulder held in adduction and internal rotation. Elbow was maintained at 90° with no range of motion at the shoulder. (b) At 3rd week, gentle pendulum exercise to the shoulder in sling as pain permits was allowed. (c) At 6th to 8th week, gentle active range of motion of the shoulder was allowed. Abduction is limited to 90°. (d) At 10th to 12th week, active to active-assistive range of motion in all planes was allowed. (e) At 12th to 14th week, isometric and isotonic exercises were prescribed to the shoulder girdle muscle.

Follow-up

All the patients were followed for a period of 6 months at regular intervals. Patients were regularly followed up for every 2 weeks. At each clinical follow, local examination of the affected clavicle for tenderness, instability, deformity, and shoulder movements were assessed. Radiological follow-up included obtaining radiographs and evaluating fracture union and implant position, X-rays were repeated every 2 weeks. Rehabilitation of the affected extremity was done according to time duration from day of surgery. Patients were followed up till radiological union was seen.


  Results Top


Age varies between 16 and 50 years with maximum patients in 16–24-year age group in TENS group whereas in Plating group, maximum patients in age group 34–42 years as well as in 43–50 years, maximum number of patients managed conservatively were in older age group, i.e., 43–50 years; the mean age of the patients was 30.58 years in TENS nailing and 33.58 years in Plating group. Mean age of patient treated conservatively was 34.92 years. The standard deviation for TENS group was 10.22, for Plating group was 10.09, and for Conservative group was 10.53 [Table 1].
Table 1: Age distribution

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Majority of the patients present within 1 week, 8 patients were admitted within 1 day while 12 patients were admitted within 1 week. Patients in the nonoperative group were treated on OPD basis [Figure 1]. They were admitted only when an associated severe injury was there. Maximum number of patients, i.e., 18 (67%) were operated within 7 days of injury and 6 patients were operated within 2 weeks of injury. Majority of patients in all three groups (TENS, Plating, and Conservative) were discharged within 10 days [Figure 2]. The man duration of stay in hospital for TENS is 9.08, for Plating is 9.42, and for Conservative is 0.83.
Figure 1: Mean time between trauma and surgery (days)

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Figure 2: Mean duration of stay in hospital (days)

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Majority of the fractures managed operatively united within 10–12 weeks (91% in TENS group and 75% in planting group). However, the ones managed conservatively were a little late to unite with majority, i.e., 64% taking more than 12 weeks [Table 2]. Mean time to union is the three groups, i.e., TENS, Plating, and Conservative which was found to be 12.18, 12.75, and 15.18 weeks, respectively. Nonunion found in two cases, one in TENS group and another in Conservative group. No non union found in Plating group [Figure 3].
Figure 3: Mean time to union (weeks)

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Table 2: Time to union (weeks)

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The functional outcome was assessed by Constant–Murley Score. Functional outcome scores were better for operative group as compared to nonoperative group. In both TENS and Plating group, results were similar, both group had excellent outcome in 50%, good is 16.7%, fair is 25%, and poor is 8.3%. In Conservative group unlike in TENS and Plating excellent, outcome was 25% only, good was 25%, fair 33.3%, and poor was 16.7% [Table 3].
Table 3: Functional outcome

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Most common associated injury was found to be distal radius fracture in all three groups. One case each of associated with tibia and fibula fracture was seen in the plated group. In the Conservative group apart from distal radius fracture, one surgical neck fracture was associated [Table 4].
Table 4: Associated injury

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  Discussion Top


Neer reported nonunion in only 3 of 2235 patients with middle third fractures treated by closed methods while Rowe reported nonunion in only 7 of 566 patients. McKee reviewed six studies with 412 patients and found that nonunion rate was higher in nonoperatively treated patients. With improved implants, prophylactic antibiotic, and better soft tissue handling techniques, plate fixation has become a reliable technique.[10] Middle third clavicle fracture commonly occurred between the age group of 34 and 42 years in 11 patients (30.56%). The youngest patient age was 19 years and oldest patient age was 50 years. The average patient's age was 33 years. In Bostman et al.'s study,[11] patients average age was 33.4 years and youngest patient age was 19 years and oldest patient age was 62 years. Mean age for the patients in TENS group was 30.58 years (16–50 years) and in Plating group, mean age was 33.58 years (16–50) while in nonoperative group was 34.92 years (16–50 years). In the Conservative group, 4 (33.3%) patients had RTA, 3 (25%) patients had fractures due to fall from two wheeler, and 5 (41.7%) due to simple fall [Table 5]. The data group, Plating and Conservative, came to be similar. In Bostman et al.'s study,[11] the mechanism of injury was due to fall from the two wheeler in 38 patients (36.8%), slipping and fall in 24 patients (23.30%), motor vehicle accident in 19 patients (18.45%), and sports in injury 22 patients (21.36%). This shows that direct injury to the shoulder is the common cause of this fracture. In operative group, 9 (75%) patients in each group (TENS and Plating) were males and 3 (25%) patients were females. In nonoperative group also, 9 (75%) patients were males and 3 (25%) patients were females. In the study of Canadian Orthopaedic Trauma Society,[12] where 85% patients were males in operative group and 70% were males in nonoperative group. Most of the fractures were right sided in operative group both in TENS group (58.3%) and Plating group (58.3%) whereas in Conservative more common on left side (75%). Associated injuries were present in 6 patients. One patient in operative group (TENS) had associated injuries which was distal radius fracture. There were 3 patients in Plating group associated with other fracture, 1 had tibia shaft fracture, 1 distal radius fracture and had fibula fracture, 2 patients in nonoperative group had associated injuries, 1 had distal radius fracture, and 1 had surgical neck humerus fracture; these fractures were managed appropriately. In Bostman et al. series,[11] there were no associated injuries. The fracture was considered to be united when clinically there was no tenderness, radiographically fracture line was not visible and full unprotected function of limb was possible. In our study, average time for union in patients treated operatively by TENS nailing was 12.18 weeks while by Plating, mean time for union is 12.75 weeks. Patients treated nonoperatively average time of union is 15.18 weeks. Similarly to the study done by McKee et al.,[10] in which union time on an average for operative group was 16.4 weeks and in nonoperative group was 28.4 weeks, union time in our study was more for nonoperative group (15.18 weeks) but less for operative group (TENS – mean for union was 12.18 weeks and Plating – average for union was 12.75 weeks). Most of the union occur within 10–12 weeks in TENS (10 cases) and Plating (9 cases), whereas in Conservative group, union generally occurs more than 12 weeks in most of the patient (cases) group. Complication was seen in 4 of 12 operated patients with TENS nailing whereas in Plating, 5 out of 12 patients show complication [Table 6]. Superficial infections found in 1 case in Plating group (4% of total cases in operative group) which were resolved with antibiotic and dressings within 2 weeks. Have et al.[13] in their study reported infection rate of 7.8% which is less than our study. Three (12.5%) patients complained of hardware irritation and shoulder pain (2 in TENS group and 1 in Plating group). One of them underwent plate removal and other nail removal while 1 refused for surgery. One patient had implant failure in TENS group with backout from the entry, she was managed with a minor operation pushing of nail in the clavicle and arm pouch immobilization as he refused for resurgery and his fracture united in 20 weeks. Two patients showing hardware failure in Plating group with screw backout from the plate, both of them refused resurgery and they were managed with arm pouch bag; in one case, union occurs at 20 weeks and in other at 16 weeks. Prominent scar was seen only in one case in Plating group. Delayed union was seen with the hardware failure complication in both TENS and Plating, 1 in TENS group and 2 in Plating group. Among nonoperative group, nonunion was seen in 3 patients but they were satisfied with their appearance and function so they refused for surgery. Two of the patients had malunion, no treatment was given to them. Delayed union was seen in 3 patients in whom fracture united at around 19–20 weeks. The rate of nonunion in study done by Kulshrestha et al.[14] was 29% and 0% in nonoperative and operative group, respectively, while in our study, it was (1 out of 12) 8.3% and (1 out of 24) 4.1%, respectively. There was a significant reduction in the risk of nonunion in the operative group compared with the nonoperative group. Statistically results were not significant for age and sex groups, but they were significant for the time to union. Findings of our study suggest that internal fixation and early mobilization of fresh displaced clavicle fractures give immediate pain relief and prevent the development of shoulder stiffness and nonunion. Although the results of operative intervention may be good in young individuals with displaced midshaft fractures, surgical intervention should be selected depending on the risk/benefit ratio for the patient individually. Patient's noncompliance with the postoperative regimen could be cause of failure of operative treatment if the patient is not motivated before surgery.
Table 5: Mode of injury

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Table 6: Complications

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  Conclusion Top


  • Our study shows according constant score, excellent result in 50% of cases in each operative group (TENS and Plating) whereas in nonoperative group, excellent result only in 25% cases and poor result are also more common in Conservative group
  • Time for union of fractures was less in operative group (TENS and Plating showing almost same mean value for union) as compared to no operative group. Union was earlier within 10–12 weeks in most of the cases in TENS group (10 cases) with respect to Plating group (9 cases)
  • There were no catastrophic complications in operative group such as brachial plexus palsy, vascular injury, or pneumothorax
  • Malunion and nonunion were more common among the nonoperative group
  • Functionally, patients were more satisfied with shoulder and its appearance following TENS and Plating
  • Early shoulder mobilization and physiotherapy program in essential for better outcome.


Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Craig EV. Fractures of the Clavicle. The Shoulder, Philadelphia: WB Saunders; 1990. p. 367-412.  Back to cited text no. 1
    
2.
Neer CS. Nonunion of the clavicle. JAMA 1960;172:1006-11.  Back to cited text no. 2
    
3.
Neviaser JS. The treatment of fractures of the clavicle. Surg Clin North Am 1963;43:1555-63.  Back to cited text no. 3
    
4.
Rowe CR. An atlas of anatomy and treatment of mid clavicular fractures. Clin Orthop 1968;58:29-42.  Back to cited text no. 4
    
5.
Paladini P, Pelegrini A, Merolla G, Campi F, Porcellini G. Treatment of clavicle fractures. Transl Med UniSa 2012;2:47-58.  Back to cited text no. 5
    
6.
Hill JM, McGurie MH, Crosby LA. Closed treatment of displaced middle third fractures of the clavicle give poor results. J Bone Joint Surg Br 1997;79B: 537-9.  Back to cited text no. 6
    
7.
Zlowodzki M, Zelle BA, Cole PA, Jeray K, McKee MD; Evidence-Based Orthopaedic Trauma Working Group. Treatment of midshaft clavicle fractures: Systemie review of 2144 fractures. J Orthop Trauma 2005;19:504-7.  Back to cited text no. 7
    
8.
Virtanen KJ, Malmivaara AO, Remesand VM, Paavola MP. Operative and non operative treatment of clavicle fractures in adults A systematic review of 1,190 patients from the literature. Acta Orthop 2012;83:65-73.  Back to cited text no. 8
    
9.
Constant CR, Murlev AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res 1987;214:160-4.  Back to cited text no. 9
    
10.
McKee RC, Whelan DB, Eli S, McKee MD. Operative versus non operative care of displaced mid shaftclavicular fractures: A meta-analysis of randomized clinical trials. J Bone Joint Surg Am 2012;94:675-84.  Back to cited text no. 10
    
11.
Böstman O, Manninen M, Pihlajamäki H. Complications of plate fixation in fresh displaced midclavicular fractures. The Journal of Trauma. 1997;43:778-783.  Back to cited text no. 11
    
12.
Canadian Orthopaedic Trauma Society. Nonoperative treatment compared with plate fixation of displaced midshaftclavicular fractures. A multicenter, randomized clinical trial. J Bone Joint Surg Am 2007;89:1-10.  Back to cited text no. 12
    
13.
Have V, Kelly L, Perdue AM. Operative versus nonoperative treatment of midshaft clavicle fractures in adolescents. J Trauma Injury Infect Crit Care 1997;43:778-83.  Back to cited text no. 13
    
14.
Kulshrestha V. Roy T, Audige L. Operative versus nonoperative management of displaced midshaft clavicle fractures: A prospective cohort study. Acta Orthop 2012;83:65-73.  Back to cited text no. 14
    


    Figures

  [Figure 1], [Figure 2], [Figure 3]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6]



 

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