Comparison of Open Reduction and Internal Fixation with Plate and Titanium Elastic Intramedullary Nail in Treating Pediatric Humeral Fracture

Abstract

Objective

To investigate the therapeutic efficacy of titanium elastic intramedullary nail (TEN) and open reduction and internal fixation with plate (ORIF) in the treatment of humeral fracture in children.

Methods

A retrospective study was carried out in a total of 69 patients who were admitted to the hospital from January 2013 to December 2018. These patients, including 41 males and 28 females, were aged from 6 to 12 years old with a median of 8 years. These patients were diagnosed with humeral fracture and underwent the surgery of ORIF (n = 22) or TEN (n = 47). The intraoperative bleeding, operation time, length of stay (LOS), and fracture healing time were compared between the two groups. The therapeutic effect was assessed by the shoulder range of motion, the elbow range of motion, the UCLA shoulder function score, and the Mayo elbow performance score (MEPS) 6 months after the surgery.

Results

The intraoperative bleeding (97.20 ± 27.83 mL vs 185.60 ± 37.50 mL, P < 0.05), the operation time (53.70 ± 11.87 min vs 73.50 ± 13.33 min, P < 0.05), and the fracture healing time (9.30 ± 4.23 weeks vs 13.45 ± 3.67 weeks, P < 0.05) in the TEN group was significantly decreased than those in the ORIF group. There was no significant difference in the LOS between the two groups. The length of follow‐up is 3 and 6 months. The shoulder range of motion (110.88° ± 15.82° vs 98.37° ± 16.22° at 3 months and 162.88° ± 17.29° vs 117.65° ± 19.38° at 6 months, both P < 0.05), the elbow range of motion (105.23° ± 2.81° vs 87.12° ± 4.73° at 3 months and 137.47° ± 4.82° vs 109.67° ± 5.83° at 6 months, both P < 0.05), and the UCLA shoulder function score (28.58 ± 4.74 vs 21.64 ± 7.23 at 3 months and 33.05 ± 3.27 vs 25.78 ± 3.87 at 6 months, both P < 0.05), and the MEPS (80.76 ± 3.53 vs 65.33 ± 9.43 at 3 months and 97.48 ± 1.23 vs 88.22 ± 3.65 at 6 months, both P < 0.05) in the TEN group were greater than those in the ORIF group. In the TEN group, complications occurred in three of 47 cases (6.38%), including one case (2.13%) of bone nonunion and two cases (4.25%) of irritation response around the nail. In the ORIF group, complications occurred in four of 22 cases (18.18%), including one case (4.55%) of delayed healing, one case (4.55%) of deep infection, and two cases (9.08%) of radial nerve injury. The complication rate was not significantly different between the two groups.

Conclusion

TEN can be a good technique for the treatment of humeral fracture in children, with the advantages of less intraoperative bleeding, shorter operative time, quicker healing, and better recovery of shoulder range of motion and elbow range of motion.

Compared with the open reduction and internal fixation with plate, titanium elastic intramedullary nail can be a good technique for the treatment of humeral fracture in children, with the advantages of less intraoperative bleeding, shorter operative time, quicker healing, and better recovery of shoulder mobility and range of motion.

Introduction

Previously, many pediatric injuries did not need surgeries. However, the surgical intervention for certain fractures have been chosen because the selection of the implants is increasing, the outcomes of the surgery are improving, compared with non‐surgical treatments. The clinical guidelines for treating pediatric femur fractures and humeral fractures have been developed by the American Academy of Orthopaedic Surgeons (AAOS) to help surgeons select the most appropriate surgical or non‐surgical treatment ¹ . Although these guidelines are helpful, the high‐level evidence is still lacking, and ideal treatments for pediatric fractures are still needed. Meanwhile, the guidelines for other types of pediatric fractures are also lacking. Therefore, studies concerning therapeutic strategies for pediatric fractures are meaningful.

The humeral fracture is one of the most common fractures in children who are younger than 16 years of age. Pediatric humeral fracture is usually caused by a high falling accident or traffic accident ² . There are many traditional surgical methods for the treatment of humeral fracture in children, such as closed reduction and plaster immobilization, open reduction and internal fixation of Kirschner wire, and open reduction and internal fixation with plate (ORIF) ³ , ⁴ , ⁵ . However, these methods have limitations. For example, ORIF can cause the disruption of large soft tissues. It can also cause the damage to patients' natural biology, resulting in the large volume of blood loss and associated neurovascular injuries ⁶ .

These surgical options for treating pediatric humeral fractures have their advantages and the disadvantages. The location of the pediatric humeral fracture is an important factor for the surgical choice. The posterior or lateral approaches are often used for the mid‐shaft to more distal fractures. The proximal one‐third to mid‐shaft fractures are approached anteriorly and anterolaterally. The possibility for an extensile exposure is an advantage of the anterolateral approach. Compared with other approaches, the anterolateral approach lowers the rates of iatrogenic radial nerve palsy (4%), while the lateral approach has a higher rate of iatrogenic radial nerve palsy (20%), and the posterior approach also has a higher rate of iatrogenic radial nerve palsy (11%) ⁷ .

Although the treatment choices for pediatric humeral fracture remain controversial, surgical techniques, including titanium elastic intramedullary nail (TEN), ORIF, and external fixation, are widely used due to their therapeutic effects ⁸ . Diaphyseal humeral fractures in preschool children prefer the conservative treatment, as the healing time is shorter in younger children, and these children may have a capacity for spontaneous correction of the deformity ⁹ . Older children have the characteristics of obvious fracture displacement, rotation and angulation instability, and they are more likely to have complications ¹⁰ . There is still no consensus regarding the age between 6 and 14; many surgeons prefer to use TEN and external fixation in open fractures ¹¹ . Therefore, more comparative studies are still needed in the therapeutic options of treating pediatric humeral fracture.

In the early 1990s, the early enthusiasm for TEN of humeral shaft fractures began in Europe ¹² , ¹³ . Accumulating studies on the topic are from Europe, particularly the experience of using the flexible nails that originated at the University of Nancy, France ¹³ . As reported, the popularity of TEN has grown in North America and other parts of the world in other long bones, such as the femur, tibia, and the forearm ¹⁴ . TEN is an elastic stable intra‐medullary nail which counteracts the distraction and compression forces at the fracture site ¹⁵ . It has been used in the treatment of humeral fracture, femoral shaft fractures, proximal humeral fractures, clavicular midshaft fractures, etc. in children ¹⁶ , ¹⁷ , ¹⁸ . For example, Rollo et al. ¹⁹ showed that humeral fracture patients treated with TEN are more satisfied compared with external fixation. Compared with traditional surgical methods, TEN has superior value to plate fixation with less blood loss, shorter operative time, and less economic loss ²⁰ . Some researchers found hospitalization time was decreased using TEN ¹⁷ . Elastic intramedullary nail achieved good results in stability and early weight bearing ²¹ . Some researchers believed that the treatment of humeral shaft fractures guarantee overlapping results with the use of ORIF, TEN, or the external fixator ²² . Others believed that the treatment of humeral shaft fractures with external fixators provide similar results as those of other techniques ²³ . These studies have reported conflicting results regarding the treatment of humeral fracture. However, the comparison between ORIF and TEN in treating humeral fracture is rarely reported.

Here, we compared the efficacy and safety of ORIF and TEN in the treatment of humeral fracture in children, aiming to add valuable evidence and provide guidance to surgeons when treating middle or distal humeral fractures in children. The purpose of the current study could be summarized into three points: (i) to compare the therapeutic efficacy between TEN and ORIF on pediatric humeral fractures; (ii) to compare the complications after the operation between TEN and ORIF; (iii) to provide a theoretical basis for treating pediatric humeral fractures using TEN.

Materials and Methods

General Information

A retrospective study was carried out and patients who were diagnosed with humeral fracture that underwent surgery from January 2013 to December 2018 in The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University were enrolled in this study. According to AO classification ²⁴ , they were classified as type A, B, or C.

Inclusion criteria were as follows (i) patients with closed fresh fracture of middle or distal one‐third humerus; (ii) patients with no symptoms of radial nerve paralysis; (iii) patients who were 6 to 12 years old and were diagnosed in accordance with AO type humeral fracture; (iv) patients who received TEN or ORIF surgeries to treat humeral fractures; (v) patients with complete data during the hospital and the follow‐ups.

Exclusion criteria were as follows (i) pathological middle or distal humeral fracture and humeral nonunion; (ii) other injuries that affect shoulder and elbow function.

Surgery Process

Anesthesia and Position (Step 1)

The patients underwent different surgeries, including TEN (n = 47) and ORIF (n = 22) according to their disease status. For ORIF, nerve block of brachial plexus was used, and patients were maintained at supine position. Anterolateral incision of the upper arm ²⁵ was taken. For TEN, patients received general anesthesia, and were maintained in supine position.

Approach and Exposure (Step 2)

For ORIF, the radial nerve was exposed through the interstitial space between the brachialis and the brachioradialis under direct vision. For TEN, a small incision (about 0.5 cm in length) was made at 2–3 cm above the internal humerus and the lateral condyle.

Pathological Changes, Resection (Step 3)

For ORIF, after the fracture reached anatomic reduction or near anatomic reduction, the 6–10‐hole compression plate was placed in the anterolateral humerus for fixation. For TEN, under C‐arm X‐ray machine, the bone cones and the long axis of humerus (an angle of 40°–60°) were slowly stabbed into cortical bone, and two intramedullary nails were used to make it pre‐curved according to the size of the humeral medullary.

Fixation or Placement of Prosthesis (Step 4)

For ORIF, cataclastic bone block or sclerite was tightly bound. For TEN, the two elastic intramedullary nails were inserted from the inside and outside of the humerus to the fracture line with elastic intramedullary nail T‐shaped holder. If closed reduction inserted into proximal fracture was unsuccessful, an incision (3 cm) was made at the fracture site to ensure a successful reduction under direct vision.

Reconstruction (Step 5)

For ORIF, if the efficacy of fracture reduction and internal fixation confirmed by C‐arm X‐ray machine was good, the incision was washed and sutured. For TEN, proximal elastic intramedullary nail was inserted into tubercle of humerus level. Nail end was cut off, and 1.0–1.5 cm of nail was retained outside the cortical bone.

Postoperative Treatment

Patients of the two groups took antibiotics for 3 days. Movement of the injured limb was restricted by neck–wrist sling suspension. After the formation of a small amount of callus, external fixator was removed, and active exercise of elbow and shoulder was kept for two weeks. The flexible nails were removed after about 6 months.

Outcome Measures

Intraoperative bleeding, operation time, length of stay (LOS), fracture healing time, shoulder range of motion and elbow range of motion at 3 and 6 months after surgery, UCLA shoulder function score ²⁶ , Mayo elbow performance score (MEPS) ²⁷ , and complications were compared between the two groups.

Length of Stay (LOS)

LOS refers to the time interval between the admission to the hospital and the discharge. LOS could indicate the therapeutic effect at hospital, and it is an important parameter that is widely used to evaluate the efficacy of the chosen treatment.

Fracture Healing Time

Fracture healing time refers to the time interval from the completion of the surgery to the healing (union or nonunion) of the fracture. Fracture healing time could indicate the therapeutic effect of the surgery, and it is an important parameter that is widely used to evaluate the complications after surgery.

UCLA Shoulder Function Score

UCLA shoulder function score was designed to evaluate the postoperative results for shoulder arthroplasty. The UCLA shoulder function score consists of pain (10 points), functions (10 points), elbow range of motion in the joint (5 points), manual muscle test (5 points), and patient satisfaction level (5 points) for a total of 35 points. The following outcome criteria are used: Excellent, 34 points; Good, 28 to 33 points; Fair, 21 to 27 points; and Poor, 20 points. At present, the UCLA shoulder function scoring system is used worldwide and shows good correlation with clinical outcome in patients who have undergone forearm‐associated surgeries.

Mayo Elbow Performance Score (MEPS)

MEPS is a widely used performance index for evaluation of clinical outcomes for a variety of elbow disorders. It consists of assessment of pain, arc of motion, stability, and a patient rating of daily function. Pain is weighted highest of the four variables. The scale ranges from 0 to 100, with a higher score indicating a better outcome.

Statistical Analysis

All data were analyzed by SPSS software (version 16.0, IBM, Armonk, NY, USA). The differences of sex, fracture site, fracture classification between the two groups were detected by χ² test. The differences of age, course of disease, intraoperative bleeding, operation time, LOS, fracture healing time, shoulder range of motion and elbow range of motion 6 months after surgery, UCLA shoulder function score, and MEPS between the two groups were detected by the t test. The P value <0.05 was considered statistically significant.

Results

General Results

A total of 69 patients were enrolled in this study, including 41 males and 28 females. They were aged from 6 to 12 years with a median of 8 years. There were 25 patients (36.2%) with middle humeral fracture, and 44 patients (63.8%) with distal humeral fracture. Humeral fracture occurred in the left side (27 cases, 39.1%) and in the right side (42 cases, 60.9%). According to AO classification, 20 cases (29.0%) belong to type A fracture, 37 cases (53.6%) belong to type B fracture, and 12 cases (14.4%) belong to type C fracture. Time interval from injury to surgery was from 1 to 8 days with a median of 3 days. There were no significant differences in sex, age, fracture site, course of disease, or fracture classification between the two groups (Table 1).

TABLE 1.

Comparison of general information between TEN group and ORIF group

Groups	Sex (n)		Age (years)	Fracture site (n)		Course (days)	Fracture classification (n)*
	Male	Female		Middle	Distal		A	B	C
TEN	28	19	8.18 ± 2.36	32	15	3.37 ± 1.58	14	26	7
ORIF	13	9	8.23 ± 1.89	12	10	3.58 ± 1.34	6	11	5
	χ2 = 0.001		t = 0.583	χ2 = 1.189		t = 1.539	χ2 = 0.641
	P = 0.970		P = 0.463	P = 0.276		P = 0.338	P = 0.726

^*Patients were classified as A, B, and C types according to AO classification. TEN, titanium elastic intramedullary nail. ORIF, open reduction and internal fixation with plate.

Intraoperative and Postoperative Results

Intraoperative bleeding in TEN group was significantly decreased compared to that of ORIF group (TEN vs ORIF, 97.20 ± 27.83 mL vs 185.60 ± 37.50 mL, P = 0.000), and operation time (TEN vs ORIF, 53.70 ± 11.87 min vs 73.50 ± 13.33 min, P = 0.001) and fracture healing time (TEN vs ORIF, 9.30 ± 4.23 weeks vs 13.45 ± 3.67 weeks, P = 0.005) in TEN group were also significantly reduced compared to the ORIF group. There was no significant difference in LOS between the two groups (TEN vs ORIF, 12.40 ± 1.58 days vs 11.80 ± 1.25 days, P = 0.963, Table 2).

TABLE 2.

Comparison of intraoperative bleeding, operation time, LOS, and fracture healing time between TEN group and ORIF group ($\overline{x}\pm s$)

Groups	Intraoperative bleeding (mL)	Operation time (min)	LOS (days)	Fracture healing time (weeks)
ORIF (n = 22)	185.60 ± 37.50	73.50 ± 13.33	11.80 ± 1.25	13.45 ± 3.67
TEN (n = 47)	97.20 ± 27.83	53.70 ± 11.87	12.40 ± 1.58	9.30 ± 4.23
t value	8.384	3.460	0.237	3.267
P value	0.000	0.001	0.963	0.005

LOS, length of stay; ORIF, open reduction and internal fixation with plate; TEN, titanium elastic intramedullary nail.

Functional Evaluation

Shoulder range of motion (TEN vs ORIF, 110.88° ± 15.82° vs 98.37° ± 16.22°, P = 0.000) and elbow range of motion (TEN vs ORIF, 105.23° ± 2.81° vs 87.12° ± 4.73°, P = 0.000) 3 months after surgery, as well as shoulder range of motion (TEN vs ORIF, 162.88° ± 17.29° vs 117.65° ± 19.38°, P = 0.000) and elbow range of motion (TEN vs ORIF, 137.47° ± 4.82° vs 109.67° ± 5.83°, P = 0.000) 6 months after surgery, in TEN group were greater than those in ORIF group. UCLA shoulder function score (TEN vs ORIF, 28.58 ± 4.74 vs 21.64 ± 7.23, P = 0.000) and MEPS (TEN vs ORIF, 80.76 ± 3.53 vs 65.33 ± 9.43, P = 0.000) 3 months after surgery, as well as UCLA shoulder function score (TEN vs ORIF, 33.05 ± 3.27 vs 25.78 ± 3.87, P = 0.000) and MEPS (TEN vs ORIF, 97.48 ± 1.23 vs 88.22 ± 3.65, P = 0.000) 6 months after surgery, were higher in TEN group than those in ORIF group (Fig. 1).

Fig. 1.

Comparison of shoulder range of motion and elbow range of motion, UCLA shoulder function score, and MEPS between TEN group and ORIF group at 3 and 6 months after surgery. MEPS, Mayo elbow performance score. TEN, titanium elastic intramedullary nail. ORIF, open reduction and internal fixation with plate. *P < 0.05.

Complications of the Patients

In a total of 47 cases treated with TEN, complications occurred in three cases (6.38%), with one case (2.13%) of bone nonunion and two cases (4.25%) of irritation response around the nail. In a total of 22 children treated with ORIF, complications occurred in four cases (18.18%), with one case (4.55%) of delayed healing, one case (4.55%) of deep infection, and two cases (9.08%) of radial nerve injury. Malunion or implant failure did not occur in any of the patients. The complication rate was not significantly different between the two groups (χ² = 2.289, P = 0.130). X‐ray films of typical cases with the treatment of ORIF and TEN were shown in Figs. 2 and 3.

Fig. 2.

The X‐ray films of a 9‐year‐old male patient with distal one‐third of humeral fracture using titanium elastic intramedullary nail (TEN) treatment. (A) Preoperative X‐ray film. (B) Postoperative X‐ray film. (C) Twelve weeks after surgery. (D) X‐ray film after pulling nail.

Fig. 3.

The X‐ray films of a 12‐year‐old male patient with middle humeral fracture using open reduction and internal fixation with plate (ORIF) treatment. (A) Preoperative X‐ray film. (B) Postoperative X‐ray film. (C) Twelve weeks after surgery. (D) X‐ray film after pulling nail.

Discussion

Comparison of the Therapeutic Efficacy between TEN and ORIF

TEN is currently considered superior in surgical treatment of long bone fractures in school‐age pediatric patients. Several biomechanical studies have been performed to investigate superiority of one material over the other for humeral shaft fractures. Westrick et al. ²⁸ showed that conservative treatment of humeral shaft fractures has a higher rate of bone nonunion, while operative treatment is associated with a low incidence of iatrogenic nerve palsy but higher rates of infection. Harkin et al. ²⁹ demonstrated that there were high rates of delayed union and nonunion with conservative management in comparison with early operative fixation, and that patients with a significant psychiatric history may benefit from consideration of operative intervention. Seo et al. ³⁰ showed that dual 3.5‐mm locking compression plate (LCP) fixation to the humerus is a possible treatment choice for diaphyseal humeral fractures in comparison with the conventional single 4.5‐mm LCP fixation. Rollo et al. ¹⁹ showed that humeral fracture patients treated with TEN are more satisfied compared with external fixation. These studies revealed that operative treatment with nails or plates is becoming an ideal choice in treating humeral shaft fractures. However, the comparison between ORIF and TEN in treating humeral fracture is rarely reported. In the current study, we compared 69 humeral fracture cases treated with TEN or ORIF and found that TEN can be an ideal strategy for the treatment of humeral fracture in children.

The treatments of humeral fracture in children are different from adults, and it is much more important in protecting epiphysis and bone blood supply for children ³¹ . Disadvantages such as bleeding and higher incidence rate of nerve and epiphysis injury are commonly seen in traditional fixation methods of ORIF with Kirschner wire, plate, and interlocking intramedullary nailing ³² . To combat these shortcomings, TEN was invented and brought many advantages in the treatment of humeral fracture in children. With the elastic characteristic, TEN could easily maintain the anatomical apposition and cross through the fracture ends. In addition, the slight move of the fracture end caused by TEN is beneficial for the formation of callus. Therefore, TEN has been widely used in the treatment of long bone fracture of limbs ³³ , ³⁴ , ³⁵ .

Comparison of the Complications after the Operation between TEN and ORIF

Most children with humeral shaft fractures are treated conservatively. However, the 1/3 of the distal end of the humerus is triangular in cross section, where the periosteum is weaker than that of the supracondylar region, resulting in poor stability and long healing time after fracture. The blood supply in the middle and distal one‐third humerus mainly comes from the nutrient vessels of middle and upper humerus. If this site is fractured, the nutrient vessels will be injured. Therefore, complications including varus of elbow joints, delayed healing, fracture relocation, malunion, and elbow dysfunction are common during non‐surgical treatment. An observation conducted by Rollo et al. ³⁶ , ³⁷ showed that plating with supporting allograft can be a good choice of treating aseptic non‐union of the humeral shaft. They also found that the plate‐and‐bone‐strut allograft technique with bone chip augmentation in distal humeral shaft for aseptic non‐unions resulted in union of all cases ³⁸ . Older children have the characteristics of obvious fracture displacement, rotation, and angulation instability, and they are more likely to have complications. For some of these fractures, we use internal fixation, including TEN and ORIF. As a retrospective study, we screened patients who had undergone surgery from previously hospitalized patients, comparing the therapeutic differences between TEN and ORIF. ORIF is not commonly used to treat young patients. However, for patients with poor outcome of conservative treatment, for example those patients who are difficult to effectively fix using brace or splint due to obesity, surgical treatment with ORIF is also an option. However, ORIF may injure the periosteum and muscle of fracture end, which leads to insufficient blood supply of fracture end ³⁹ . TEN avoids large‐scale dissection of soft tissue and periosteum. It has limited side effects on bone blood supply and soft tissue injury, and can avoid radial nerve injury and keep the blood circulation of the fracture part and the fixed area, thus to promote fracture healing ⁴⁰ , ⁴¹ .

Clinical Experience for Treating Pediatric Humeral Fractures Using TEN

During the TEN surgery, previous studies have summarized some methods dealing with the troubles we met in treating a humeral fracture, which were: (i) the diameter of TEN should be 50%–60% of the narrowest part of the humeral shaft. TEN with a diameter of 2.5 mm is recommended for children aged 6–10 years, and 3.0–3.5 mm is recommended for children over 10 years; (ii) the thicker the TEN, the stronger the elasticity and fixation. However, the difficulty of insertion will increase; and (iii) postoperative irritability reaction around nails should be watched ⁴² , ⁴³ .

Limitations of the Study

The limitation of this study is that the sample size is small. Also, this study lacks the data from patients who received the conservative treatment or the external fixation. Therefore, larger samples and randomized controlled studies are still needed in our future research.

Conclusion

Our findings demonstrated that TEN can be an ideal technique for the treatment of humeral fracture in children with the advantages of less intraoperative bleeding, shorter operative time, quicker healing, and better recovery of shoulder range of motion and elbow range of motion.