Comparison of the efficacy of intramedullary nail, locking plate and conser | CIA

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Back to Journal »Clinical Interventions for Aging» Volume 12

Authors: Ge Wei, Sun Q, Li Geng, Lu Geng, Cai Mei, Li Sheng

Published on November 29, 2017 2017 Volume: 12 pages 2047-2054

DOI https://doi.org/10.2147/CIA.S144084

Single anonymous peer review

Editor approved for publication: Dr. Wu Zhiying

Wei Ge,* Qi Sun,* Gen Li, Guohua Lu, Ming Cai, Shaohua Li, Department of Orthopedics, Tenth People's Hospital, Shanghai Tongji University School of Medicine* These authors contributed equally to this work. Objective: Incidence of proximal humeral fractures in the elderly Very high, the advanced treatment of these fractures is still controversial. This study aims to compare the clinical results of intramedullary nails, locking plates, and conservative treatments for displaced proximal humeral fractures in the elderly. Patients and methods: In this prospective study, a total of 198 patients with 2 or 3 partial fractures of the proximal humerus who received locking plate or intramedullary nail fixation or conservative treatment were enrolled. The main result is the Constant-Murley score over 24 months. Secondary results include the American Shoulder and Elbow Surgeon (ASES) score, visual analog scale (VAS) pain score, shoulder mobility, and complication rate. Results: There was no statistically significant difference in the Constant-Murley score and ASES score between the plate group, the nail group and the conservative group. For three-part fractures, the Constant-Murley score and ASES score of the conservative group were lower than those of the plate group and nail group. In addition, the conservative group showed significantly lower external rotation during follow-up. The complication rates of two-part and three-part fractures in the plate group, nail group and conservative group were similar. Conclusion: Locking steel plate, intramedullary nail or conservative treatment of the second-segment fracture of the proximal humerus in the elderly can achieve similar satisfactory functional effects. The advantages in terms of functional results are conducive to the treatment of 3-part proximal humeral fractures with locking plates and intramedullary nails. Keywords: proximal humerus fracture, intramedullary nail, locking plate, conservative treatment, elderly

Proximal humeral fractures are the second most common upper limb fractures in the elderly, accounting for 5% of all adult fractures. 1 The incidence of proximal humeral fractures is higher among older people with a longer life expectancy. 2 Non-displaced and micro-displaced fractures, as most proximal humeral fractures, can be treated conservatively to obtain satisfactory shoulder function. 3 However, for displaced proximal humeral fractures in the elderly, there are many options, including surgery and conservative treatment to treat these fractures.

Open reduction and internal fixation is currently the most common treatment for most displaced proximal humeral fractures. Locking plates and intramedullary nails are often used for stable fixation of proximal humeral fractures. 4,5 According to reports, locking plates are effective in treating displaced proximal humeral fractures, but the complication rate is high. 6-8 Therefore, intramedullary nails have become an attractive alternative treatment method due to their superior biomechanical advantages, including significant stiffness and higher failure load. 9,10 However, intramedullary nails are not effective for fracture reduction, and rotator cuff injury may affect shoulder function. 11, 12 Conservative treatment is another option for proximal humeral fractures in the elderly. Although conservative treatment cannot achieve stable fracture fixation, better imaging results and early mobility, it has been reported to lead to satisfactory shoulder function and a lower incidence of complications. 13,14

The advanced treatment of displaced proximal humeral fractures in the elderly remains controversial. In several previous studies, proximal humeral fractures were treated with intramedullary nails, locking plates, or conservative treatments, but various clinical results and complications were reported. 12,15,16 The treatment of proximal humeral fractures has not reached a consistent conclusion. Only one retrospective study compared the functional results of locking plates, intramedullary nails, and conservative treatment of displaced proximal humeral fractures, but the sample size was not large enough. 16 Therefore, high-level evidence trials are needed to explore whether there are locking plates, intramedullary nails, and conservative treatment of the best treatment options for displaced proximal humeral fractures in the elderly. We conducted a prospective study to compare the clinical outcomes of locking plates, intramedullary nails, and conservative treatment of displaced proximal humeral fractures in the elderly.

The study recruited 198 patients with displaced proximal humeral fractures between February 2010 and December 2014. They are arranged for fixed locking plates or intramedullary nails or conservative treatment. Inclusion criteria included 2-part proximal humerus fractures or 3-part proximal humeral fractures (classified according to the Neer system) and patients older than 60 years old. The exclusion criteria were: multiple fractures of the ipsilateral upper extremity, open fractures, pathological fractures, complicated nerve plexus or nerve damage, severe mental illness, and systemic diseases that affected fracture healing. According to the judgment of the treating physician and the final patient, patients are divided into plate group (locking plate) or nail group (intramedullary nail) (Figure 1). Patients who refused surgical treatment and only agreed to receive conservative treatment constituted the conservative group. Obtain X-rays including anterior and posterior views of the shoulder, side views of the scapula, and Velpeau axillary views to confirm the type of fracture. This prospective study was approved by the Medical Ethics Committee and Institutional Review Committee of Shanghai Tenth People's Hospital. Written informed consent was obtained from all patients before participating. The study was conducted in accordance with the standards of the Declaration of Helsinki.

Figure 1 Flow chart of patients included in the study.

All operations were performed in a beach chair position under general anesthesia.

The triangular thoracic method was used to expose the fracture site of the plate group. When further dissecting the soft tissues, pay attention to minimize the damage to the soft tissues and the blood supply of debris. With the help of the C-arm fluoroscopy machine, direct and indirect reduction was performed to reconstruct the anatomical structure of the proximal humerus. Then, place the locking plate on the outside of the biceps groove and 1 cm below the greater tuberosity of the humerus to repair the proximal humerus. Next, fix the bicortical screw to the humeral shaft to fix the bone plate, and use the C-arm fluoroscopy machine to check the position of the bone plate. After confirming that the reduction is good and the bone plate is in good position, insert at least 5 locking screws proximally, and then insert more distal locking screws. Finally, use non-absorbable sutures to secure the rotator cuff through the proximal plate hole, and suture the wound carefully.

After closed reduction of proximal humeral fractures, a deltoid split approach and a rotator cuff incision were used. Then, a Kirschner wire was used to temporarily fix the fracture fragments 1 cm inside the greater tubercle to determine the entry point. Then, the humeral tube is reamed after the guide wire is introduced through the entry point. Insert the intramedullary nail connected with the targeting device into the medullary cavity together with the guide wire until the intramedullary nail reaches under the cartilage. Then, insert 3 proximal locking screws and 2 distal locking screws with drill sleeve and targeting sleeve, respectively. Finally, the rotator cuff is carefully sutured with non-absorbable sutures, and the wound is sutured carefully.

The postoperative rehabilitation program of the steel plate group and the nail group was the same. Use a sling bandage to stabilize the affected limb against the chest for 4 weeks. Passive exercise started on the first day after surgery, and active assisted and active exercises started 6 weeks after surgery. Active resistance exercise started 3 months after the operation.

Closed reduction was performed when the fracture mass shifted> 50% of the diameter of the bone shaft, and the reduction was confirmed by X-ray. Patients receiving conservative treatment were secured with a sling bandage, and the arm was stabilized against the chest for 4 weeks. Passive range exercises started after 2 weeks, supervised by a physical therapist for the first time. The other rehabilitation programs of the conservative group are the same as the postoperative rehabilitation programs of the surgery group.

Patients were followed up at 2, 1, 3, 6, 12, and 24 months. Physical examinations were performed at 6, 12, and 24 months after surgery. Use a standard goniometer to measure the range of shoulder movement. The main result is the Constant-Murley score evaluated during the 24-month follow-up of the study. Record the American Shoulder and Elbow Surgeon (ASES) score and the 10 cm visual analog scale (VAS) pain score for further evaluation.

X-rays of the proximal humerus were obtained immediately after surgery and at 1, 3, 6, 12, and 24 months. X-rays were evaluated for bone healing, complications, and neck-shaft angle. Bone healing is defined as the presence of bridging callus at the fracture site. Complications during the entire follow-up period were recorded, including osteonecrosis, nonunion or nonunion of fractures, screw penetration, and loss of reduction.

This study uses SPSS Statistics Version 19.0 for statistical analysis. Continuous variables and categorical variables were summarized as mean ± standard deviation and absolute number (percentage). Chi-square test is suitable for categorical variables, and Student's t test is suitable for continuous variables with normal distribution. Continuous variables with normal distribution use Mann-Whitney U test. P<0.05 was considered a significant difference.

A total of 184 patients (92.9%) completed at least 24 months of follow-up. There were 1, 5, and 3 cases lost to follow-up in the steel plate group, nail group and conservative group, and 2, 2, and 1 cases died. The demographic characteristics of each group were comparable, and there were no differences in age, fracture type, and medial cortical comminution (Table 1). There were 97 cases of two-segment fractures (38 cases in the plate group, 36 cases in the nail group, 23 cases in the conservative group), 87 cases of three-segment fractures (31 cases in the plate group, 36 cases in the nail group, and 20 in the conservative group). Medial cortex comminuted occurred in 18 cases in the steel plate group, 21 cases in the nail group, and 10 cases in the conservative group. There was no difference in bone healing time between the plate group (14.2±2.8 weeks), the nail group (14.6±3.2 weeks) and the conservative group (15.1±2.9 weeks).

For two-part fractures of the proximal humerus, there was no significant difference in the Constant-Murley score and ASES score of the plate group, nail group, and conservative group (Table 2). During the 6-month follow-up, the conservative group showed a higher VAS score and lower anterior elevation than the plate group and nail group. There were no significant differences in the anterior elevation and VAS scores in the plate group, the nail group and the conservative group at the 12-month and 24-month follow-up. During the entire follow-up period, the external rotation of the plate group and the nail group were significantly greater than that of the conservative group, and there was no statistical difference between the plate group and the nail group (Figure 2).

Table 2 The clinical efficacy of locking steel plate, intramedullary nail and conservative treatment of two-part proximal humeral fractures Note: Δ and ⋇ indicate the significant difference between two values ​​with the same symbol in the same row. Abbreviations: ASES, American shoulder and elbow surgeon; VAS, visual analog scale.

Figure 2 Clinical results of locking plate, intramedullary nail, and conservative treatment of two-part fractures of the proximal humerus. Δ represents a significant difference between the two values. Abbreviation: ASES, American shoulder and elbow surgeon.

For three-part fractures of the proximal humerus, the Constant-Murley scores of the plate group and nail group were significantly higher than those of the conservative group, and only the ASES score of the plate group was statistically higher than that of the conservative group (Table 3). The Constant-Murley score and ASES score between the steel plate group and the nail group are comparable. At the 6-month follow-up, the front elevation of the steel plate group and the nail group was higher than that of the conservative group, and the VAS score of the nail group was higher than that of the conservative group. The VAS score of the steel plate group was significantly lower than that of the conservative group, but it did not reach significance (P=0.066). At the 12-month and 24-month follow-up, there was no statistical difference in anterior elevation and VAS scores between the 3 groups (Figure 3). The external rotation of the conservative group was significantly reduced, but there was no statistical difference between the nail group and the steel plate group.

Table 3 The clinical efficacy of locking steel plate, intramedullary nail and conservative treatment of three-segment fractures of the proximal humerus Note: Δ and ⋇ indicate the significant difference between two values ​​with the same symbol in the same row. Abbreviations: ASES, American shoulder and elbow surgeon; VAS, visual analog scale.

Figure 3 The clinical results of locking plate, intramedullary nail and conservative treatment of three-segment fractures of the proximal humerus. Δ represents a significant difference between the two values. Abbreviation: ASES, American shoulder and elbow surgeon.

A total of 38 complications were recorded, 18 cases (26.1%) in the plate group (7 cases of two-part fractures, 11 cases of three-part fractures), 13 cases (18.1%) in the plate group (5 cases of two-part fractures, 8 cases of three-part fractures) . Partial fractures) were in the nail group, while there were 4 cases (9.3%) in the conservative group (1 with 2 partial fractures and 3 with 3 partial fractures). There was no significant difference in the total complication rate of the second-segment fracture and the third-segment fracture of the proximal humerus in the plate group, nail group and conservative group. In the plate group, there were 8 cases of screw penetration, 3 cases of avascular necrosis, 3 cases of acromion impingement, 2 cases of fracture displacement, 1 case of nonunion, and 1 case of infection. For intramedullary nails, 6 screw penetrations, 3 rotator cuff injuries, 2 avascular necrosis, and 2 fracture displacements were observed. Conservative treatment was performed in 2 cases of shoulder stiffness, 1 case of avascular necrosis, and 1 case of nonunion.

The increase in the proportion of elderly people and more active lifestyles have increased the incidence of proximal humeral fractures,17 and the treatment of displaced proximal humeral fractures in the elderly is still controversial. We conducted a prospective study to evaluate the effects of locking plates, intramedullary nails, and conservative treatment on displaced proximal humeral fractures in the elderly. We found that locking plates, intramedullary nails, and conservative treatment are comparable in restoring shoulder function for two-part fractures of the proximal humerus. There was no significant difference in the three-part fracture shoulder function score between the plate group and the nail group, but it was significantly higher than that of the conservative group. Throughout the follow-up period, the two-part and three-part fractures in the conservative group showed smaller external rotation. After the last follow-up, there was no statistically significant difference in anterior elevation, VAS score, and total complication rate among the three groups.

In our study, the plate group and the nail group showed similar shoulder function scores in the two and three parts of the proximal humeral fracture. Several studies have obtained good clinical results by comparing intramedullary nails and locking plates for the treatment of proximal humeral fractures. 11,12,15,18-20 Zhu et al.12 conducted a randomized controlled study comparing the functional results between intramedullary nails and locking plates for the treatment of proximal humeral fractures. 2 partial proximal humeral fractures and concluded that the two implants can achieve satisfactory results in the treatment of 2 partial proximal humeral fractures, and there is no statistical difference at the final follow-up. Gracitelli et al. 15 concluded that locking plates and intramedullary nails have similar clinical and radiological results when fixing two and three parts of proximal humeral fractures. A retrospective study compared 4 common methods for treating 2-part and 3-4 part proximal humeral fractures and concluded that locking plates and intramedullary nails have comparable results for 2-part and 3-4 part fractures. 16 Compared with the previous two randomized controlled studies, the Constant-Murley score of our study is similar to the study of Gracitelli et al. 15 but not as good as the study of Zhu et al. 12 This difference may be due to the fact that three-part fractures of the proximal humerus were included and the average age of the patients in our study was greater. In addition, the average Constant-Murley score at the final follow-up of most studies is usually between 70 and 90, which is the same as our results. A randomized controlled trial showed that the overall complication rate of intramedullary nails was significantly higher,15 but Zhu et al.12 and Hardeman et al.21 reported that when patients were treated with locking plates, the complication rate was higher. In our study, the absolute number of total complications in the plate group was higher, but the total complication rate did not reach a statistical difference, which is the same as the conclusion reported in the meta-analysis, that is, the total complication rate did not show statistics Difference 22 The anterior lift and external rotation between the intramedullary nail and the locking plate were not as good as the plate group, but did not reach statistical differences. The injury to the supraspinatus tendon during intramedullary nailing may explain the lower anterior lift and external rotation in the intramedullary nail group. twenty three

Conservative treatment is suitable for non-displaced or slightly displaced fractures, with reasonable functional results and few complications. 24 In this study, the functional results of intramedullary nails and locking plates were comparable to those of conservative treatment of two-part proximal humeral fractures. These results are consistent with a previous work that reported that intramedullary nails and locking plates failed to find more beneficial clinical results than conservative treatment of proximal humeral fractures. 16 A multicenter randomized clinical trial involving patients with displaced proximal humeral fractures involving surgical necks concluded that surgical treatment failed to achieve better patient-reported clinical outcomes than non-surgical treatments at the overall or individual time points . 25 In the above studies, most fractures were slightly displaced or two-part fractures. Hauschild et al24 proved that conservative treatment and surgical treatment (locking plate and intramedullary nail) are both safe and effective treatment options for two-part proximal humeral fractures. They reported that the range of motion was better in the early postoperative period, and the pain reduction gradually diminished over time and became comparable at the final follow-up. 24 In our study, the shoulder function scores of the surgical group and the conservative group were similar. During the 6-month follow-up of VAS, the score and forward elevation of the surgical group were only better in the management of 2-part and 3-part fractures. . However, for two-part and three-part fractures, the shoulder external rotation was still significantly smaller in the conservative group. Pain may partially affect the range of motion, especially forward elevation. In addition, external rotation mainly relies on the infraspinatus and teres minor muscles, which are attached to the greater tuberosity of the humerus. 26,27 Displaced fractures were tightly reduced, and the large nodules in the conservative group were not fixed. Therefore, a good position of the large nodules in the surgical group may contribute to better external rotation.

The advantages of functional results are conducive to the use of locking plates and intramedullary nails for the treatment of three-part proximal humeral fractures. Olerud et al28 conducted a randomized controlled trial of three-part fractures in elderly patients to compare conservative treatment with locking plates. The results show that the locking plate is superior to the supportive clinical results of conservative treatment. However, another randomized controlled trial reported that there was no difference in the functional outcomes of conservative treatment and locking plates for patients with three-part and four-part fractures older than 60 years of age. 29 However, it is difficult to interpret the comparison because people who mixed 3-part and 4-part fractures were analyzed together. Shoulder function scores may be largely affected by four-part fractures. When conservatively treating displaced proximal humeral fractures, the initial displacement is related to the progression of the displacement. 30 Therefore, the displacement progress of the three-part fracture with a large displacement before operation in the conservative group may be greater than that in the plate group and nail group. Surgery, locking plates and intramedullary nails can provide a more stable fixation to prevent further displacement, resulting in better clinical results for three-part fractures. A clinical study showed that conservative treatment of the 3 and 4 parts of proximal humeral fractures in the elderly (>75 years old) has good pain relief effects, but the functional results are limited, but the functional results are limited, and there is no impact on daily life. 31 The Constant-Murley score reported by conservative treatment is lower than the score of this study (79.07±8.39), which may be due to the inclusion of 4 fractures and the older patients. Locking plates are currently used for displaced 2-part, 3-part, and 4-part proximal humeral fractures, but it has been reported to be associated with higher complications, ranging from 16% to 64%. 32 In our study, for two-part and three-part fractures, although the incidence of complications in the plate group was significantly higher than that in the conservative group, there was no significant difference.

Our research has several limitations. This prospective study did not randomize patients, but the basic demographic characteristics are comparable. Surgeons and physical therapists will not turn a blind eye to the type of treatment, which can lead to prejudice. In addition, short-term follow-up may lead to an underestimation of the incidence of long-term complications. Another limitation is the small sample size of our study. Therefore, it is necessary to conduct a prospective randomized controlled study with large samples and long-term follow-up.

For elderly two-part fractures of the proximal humerus, similar satisfactory functional results can be obtained by locking plates, intramedullary nails or conservative treatment. The advantages in terms of functional results are conducive to the treatment of 3-part proximal humeral fractures with locking plates and intramedullary nails.

Thanks to Wu Jiezhou, Li Renlong and Hu Hengda (all from the Department of Orthopedics, Shanghai Tenth People’s Hospital, Shanghai Tongji University School of Medicine, China) and Li Xifan (Department of Radiology, Shanghai Tenth People’s Hospital, Tongji University, Shanghai, China) for their technical assistance and useful discuss.

All authors contributed to data analysis, drafting and critical revision of the paper, and agreed to be responsible for all aspects of the work.

The authors report no conflicts of interest in this work.

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