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 Table of Contents  
ORIGINAL ARTICLE
Year : 2023  |  Volume : 6  |  Issue : 2  |  Page : 142-148

Randomized clinical trial to assess functional outcome and complication of surgical neck humerus fracture (two part and three part) treated by percutaneous K-wire fixation and Philos plating


1 Department of Orthopedics, Dr. Panjabrao Deshmukh Medical College, Amravati, Maharashtra, India
2 Department of Orthopedics, Dr. Panjabrao Deshmukh Memorial Medical College and Hospital, Amravati, Maharashtra, India

Date of Submission01-Sep-2022
Date of Decision12-Oct-2022
Date of Acceptance21-Nov-2022
Date of Web Publication3-May-2023

Correspondence Address:
Akash Bhakare
Dr. Panjabrao Deshmukh Medical College, Amravati, Maharashtra, India Instead of Neuron Institute of Applied Research, Amravati, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jodp.jodp_76_22

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  Abstract 


Background: Proximal humeral fracture, whether caused by trauma or osteoporosis, requires meticulously planned individual treatment. The technique and devices used are determined by the quality of bone and soft tissue, age, and reliability of the patients. The purpose of this study is to evaluate the functional outcomes and complications of surgical neck humerus fractures (two part and three part) treated by percutaneous K-wire fixation and PHILOS plating. Methodology: The study includes patients with proximal neck humerus fractures (two-part and three-part) according to Neer's classification who underwent open reduction and internal fixation with a PHILOS locking plate and percutaneous K-wire fixation. Functional outcomes and complications were evaluated by the Shoulder Constant score (SCS). Patients were followed up at 1, 3, and 6 month intervals until fracture union. In this study, a total of 76 patients were chosen and divided into two groups, i.e., Group A and Group B, each comprising 38 patients. Patients of Group A were treated with ORIF PHILOS plating and patients of Group B were treated with closed reduction and internal fixation (CRIF) percutaneous K-wire fixation. Results: ORIF PHILOS plating was used on 20 (26%) of patients who had an excellent SCS. 10 (13%) patients exhibited a good grade, 5 (6%) patients had a fair grade, and the remaining 3 (4%) patients displayed a poor grade. In Group B, 12 (16%) of patients treated with closed reduction with K-wire fixation had excellent grades, 7 (9%) patients had good grades, 16 (21%) received fair grades, and the remaining 3 (4%) received poor grades. After comparing both treatments, a P value was found to be 0.0403, which shows Group A was more efficient than Group B. Conclusion: The results of our study concluded that, as compared to ORIFPHILOS plating treatment with the CRIF K-wire fixation treatment has poor functional outcomes and a high failure rate. In addition, the surgical treatment of proximal neck humerus fractures (two part and three part) in both groups showed that the PHILOS plating provides an excellent way to achieve the goal, including time of union, fewer complications, and good functional outcomes as compared to percutaneous K-wire.

Keywords: K-wire, neck humerus fracture, PHILOS plating, surgery, trauma


How to cite this article:
Bhakare A, Pundkar G, Baitule R, Jaiswal S, Kharat S, Rokade A. Randomized clinical trial to assess functional outcome and complication of surgical neck humerus fracture (two part and three part) treated by percutaneous K-wire fixation and Philos plating. J Orthop Dis Traumatol 2023;6:142-8

How to cite this URL:
Bhakare A, Pundkar G, Baitule R, Jaiswal S, Kharat S, Rokade A. Randomized clinical trial to assess functional outcome and complication of surgical neck humerus fracture (two part and three part) treated by percutaneous K-wire fixation and Philos plating. J Orthop Dis Traumatol [serial online] 2023 [cited 2023 Jun 4];6:142-8. Available from: https://jodt.org/text.asp?2023/6/2/142/375554




  Introduction Top


The incidence of proximal humerus fracture is between 4% and 5% of all fractures.[1] They represent the third-most common fracture in elderly patients after fractures of the hip and distal radius which are strongly associated with osteoporosis.[2] The vast majority are low-energy osteoporotic fractures resulting from simple falls[3] with a 2-3-1 female-to-male preponderance.[4],[5],[6] Road traffic accidents (RTAs) and an increase in osteoporosis incidence are both contributing to an increase in proximal humerus fractures.[7] In patients above 65 years of age, these are the third-most common fractures, after hip and distal radius fractures. Minimally displaced fractures, regardless of the number of fracture lines, can be treated with closed reduction, but displaced fractures require anatomical reduction with internal fixation.[8],[9]

The functional outcome after surgical management depends upon various factors such as fracture reduction, quality of bone, quality of the fixation implant selection, and postoperative mobilization. Each of the surgical techniques provides a different functional outcome. Locking plate fixation preserves the biological integrity of the humeral head with perfect anatomical reduction by using multiple locking screws with angle stability, thereby allowing for early mobilization of the limb.[10] Percutaneous pinning and ORIF-plate fixation can be done in almost all the fractures (2, 3, 4 part fractures) except in cases of extensive comminution, which needs a hemiarthroplasty procedure. Controversy exists regarding the ideal treatment of proximal humerus fractures.

Several treatment modalities have been proposed depending on the fracture pattern, patients' age and level of activity, and associated medical comorbidities: conservative treatment,[11] open reduction and internal fixation (ORIF),[12] joint replacement,[13],[14] and percutaneous fixation.[15] Good clinical results were seen in 92% of cases treated with ORIF, 87% of cases treated with conservative treatment, 72% of cases treated with percutaneous K-wire fixation, and 87.5% of cases treated with shoulder arthroplasty.

We have already been studying various modalities of surgical treatment for fractured surgical neck humerus (two and three parts), where there still exists a lot of dilemma due to various schools of thought put forth by the surgeons on whether the PHILOS plating or percutaneous K-wire fixation for fractured surgical neck humerus gives a better functional outcome for two and three parts. Various studies have focused on the benefits and drawbacks of PHILOS plating over percutaneous K-wire, such as stable fixation and early mobilization.

Claiming that percutaneous K-wire fixation has advantages over PHILOS plating, such as K-wire being a minimally invasive technique, fewer infections, less soft tissue damage, and a slight difference in functional outcome between the two studies. Thus, we have considered the need for further evaluating the functional outcome and complications for both techniques at a tertiary health center to resolve this dilemma.

The purpose of the study was to analyze the functional outcome of displaced two-part and three-part fractures of the proximal humerus managed by ORIF with a locking plate and with percutaneous K-wire fixation.


  Methodology Top


In this study, patients having fractures in the surgical neck humerus (two-part and three-part) according to Neer's classification from January 1, 2020 to June 30, 2022 (29 months) at the orthopedics department of a tertiary health-care center were selected. In our study, open-label, odd, and even group allocation, as well as randomized sampling, were used.

Inclusion criterion

  • Patients of both genders and of age groups 18–60 years were selected
  • Patients showing displaced proximal humerus fractures 2 and 3 part with the displacement of 1 cm or 45-degree angulation were selected.


Exclusion criterion

  • Patients with age less than 18 years
  • Patients who were not willing to participate in the study
  • Patients having pathological fractures and four-part fracture and patients with undisplaced fractures
  • The patients with fracture dislocation were eliminated.


Operative procedure

Group A

Surgery was performed under the supraclavicular block, patient in a supine position with a small sandbag under the shoulder. All patients received prophylactic doses of intravenous antibiotics preoperatively. The preoperative X-ray of the two-part surgical neck humerus fracture was taken, which is shown in [Figure 1]. The fracture was exposed through a deltopectoral approach, and fracture fragments were reduced. The reduced fracture fragments were held in position with K-wires under the guidance of an image intensifier. Definitive fixation with the PHILOS plate was done with the plate positioned lateral to the bicipital groove, sparing the tendon of the long head of the biceps. The plate was placed at least 1 cm distal to the upper end of the greater tubercle. The required lengths of the locking screws were determined with a direct measuring device over the K-wire, and at least six locking screws were inserted in the humeral head; lesser tuberosity was fixed with separate screws or wires if found to be avulsed. Range of motion (ROM) of shoulder and impingement were checked on the table. Wound was closed in layers with a suction drain. An immediate postoperative X-ray was taken, which is enumerated in [Figure 2]. Passive ROM exercises were initiated on the 2nd postoperative day. Sutures were removed after 12–15 days. Active shoulder mobilization exercises were started 4–6 weeks postoperatively, depending on the patient's cooperation. Follow-up was at 1 month, then every month for 3 months, and then at 6 months regular intervals after approval of the scientific committee, which is shown in [Figure 3] and [Figure 4]. Standard anteroposterior, axillary and lateral radiographs were obtained and evaluated for fracture healing, nonunion, malunion, loosening of the implant, loss of reduction, and avascular necrosis of the head of humerus. Clinical examination included ROM and strength evaluation, pain assessment according to a Visual Analog Scale (VAS), and shoulder constant score (SCS). The criteria for radiographic healing were when all fragments showed substantial cortical continuity.
Figure 1: Preoperative X-ray two-part surgical neck humerus fracture

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Figure 2: Immediate postoperative X-ray two-part surgical neck humerus fracture

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Figure 3: Postoperative follow-up after 1 month

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Figure 4: Postoperative follow-up after 1 month

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Group B

Surgery was performed under supraclavicular block with the patient in the beach chair position. The preoperative X-ray was taken, which is illustrated in [Figure 5]. Near anatomical reduction was achieved by manual traction and arm mobilization. Three to four 2.5-mm K-wires under the image intensifier were inserted depending on the number of fracture fragments. In the case of difficult reduction, one K-wire of 3.5 mm was used as a joystick. Care was taken on the orientation and pin placement to avoid injury to the axillary nerve, the radial nerve, and the anterior circumflex humeral vessels lying medially. K-wires were left out of the skin and bent at the extremity to control migration. The postoperative X-ray of the three-part surgical neck humerus fracture was taken, which is shown in [Figure 6]. Patients were encouraged to start active mobilization of the wrist and elbow on the 2nd postoperative day. Dressing of the pin tracts was done on alternate days. Passive ROM exercises were initiated on the 2nd postoperative day. Active shoulder mobilization exercises were started at 4–6 weeks postoperatively, depending on patient's cooperation. Patients were followed up for a period of 1 month, 3 months, and 6 months at regular intervals after approval of the scientific committee, which is shown [Figure 4]. Standard anteroposterior, axillary, and lateral radiographs were obtained and evaluated for bony healing, nonunion, malunion, loosening of the implant, loss of reduction, and avascular necrosis of the head of the humerus. Clinical examination included ROM and strength evaluation, and pain assessment according to a VAS and SCS. The criteria for radiographic healing were when all fragments showed substantial cortical continuity.
Figure 5: Preoperative X-ray three-part surgical neck humerus fracture

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Figure 6: Immediate postoperative X-ray three-part surgical neck humerus fracture

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  Results Top


In this study, a total of 76 patients were chosen and divided into two groups i.e., Group A and Group B, each comprising 38 patients. Patients of Group A were treated with ORIF PHILOS plating, and patients of Group B were treated with closed reduction and internal fixation (CRIF) percutaneous K-wire fixation.

Mode of injury

The mode of fracture was either RTA or due to fall. Out of 38 patients, 53% (20 out of 38) were injured due to RTA, and 47% (18 out of 38) were injured due to falling in (Group A). Similarly, in (Group B) out of 38 patients, 47% (18 out of 38) were injured due to RTA, and 53% (20 out of 38) were injured due to fall [Table 1].
Table 1: Mode of injury of patients, fracture type, and comorbidities in patients

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Sex of patients

The study included a total of 38 patients in each group; 25 (66%) were female patients, and 13 (34) were male patients. According to Group B patients, 18 out of 38 (47%) were females, while 20 out of 38 (53%) were males. According to Group B patients, 18 out of 38 (47%) were females, while 20 out of 38 (53%) were males [Table 1].

Fracture classification

A total of 38 patients in each group were diagnosed with fractures, and according to Neer's classification criteria, the types of fractures were classified into two categories: two-part and three-part fractures. In Group A, 24 out of 38 (63%) patients had two-part fractures, while 14 out of 38 (37%) patients had three-part fractures. Similarly, in Group B, in 38 cases, 18 (47%) had two-part fractures, while 20 (53%) had three-part fractures [Table 1].

Comorbidities

The majority of cases exhibited no comorbidities in the present study. Among 38 patients, 5 out of 38 (13%) had diabetes mellitus (DM), only 1 (3%) had both DM and hypertension (HTN), 8 out of 38 (21%) had only HTN, and 24 out of 38 (63%) showed none of the mentioned comorbidities in Group A. However, in Group B, only one patient had both comorbidities, i.e., DM and HTN. Whereas 10% of patients were found to have DM, only HTN and the rest of the 29 (76%) patients did not have any of the mentioned comorbidities [Table 1].

Time of interval, operative time, and time to union

The mean time interval (in days) between the trauma and surgery was found to be 4.921052632 in Group A and in Group B, it was found to be 4.868421053. Whereas, in Group A, the mean time to union (in weeks) was 11.52631579, and in Group B, it was found to be 12.36842105 [Table 2].
Table 2: Comparison of time to union for treatment with percutaneous K-wire fixation and PHILOS plating

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Postoperative complications

Various complications were observed among the patients after the union by Group A and Group B. In the present investigation, numerous postoperative complications have been reported, including avascular necrosis of the head, impingement, wound infection, and without any complications, were found to be 1, 1, 2, and 33, respectively, in Group A.

Similarly, Group B consisted of 38 patients. In Group B, there was only 1 (3%) patient with avascular necrosis of the head, 1 patient with impingement, 2 (5%) patients with wound infection, and 33 (87%) patients without any complications.

Shoulder constant score

Group A

SCS was recorded after operating on patients. After a 1-month follow-up, 9 of 38 (24%) patients received an excellent grade. 12 out of 38 (32%) patients had a good grade, 7 out of 38 (18%) patients had a fair grade, and 10 out of 38 (26%) patients showed a poor grade, as shown in [Figure 3].

In the case of postoperative follow-up of 3 months, 11 out of 38 (29%) patients had excellent grades; 7 out of 38 (18%) patients showed good grades; 12 out of 38 (32%) patients had fair grades; and 8 out of 38 (21%) patients showed poor grades.

Finally, after the follow-up of 6 months, 20 out of 38 (53%) patients showed excellent grades, 10 out of 38 (26%) patients had a good grade, 5 out of 38 (13%) patients exhibited fair grades, and 3 out of 38 (8%) patients showed poor grade, as illustrated in [Figure 7] [Table 3].
Figure 7: Postoperative follow-up after 6 months with PHILOS plating

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Table 3: Postoperative shoulder constant score of patients after follow-up of 1, 3, and 6 months

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Group B

After the follow-up of 1 month, 9 out of 38 (24%) patients showed excellent grades. 12 out of 38 (32%) patients had good grades, 7 out of 38 (18%) patients had fair grades, and 10 out of 38 (26%) patients showed poor grades, which is shown in [Figure 4].

In the case of postoperative follow-up of 3 months, 11 out of 38 (29%) patients had excellent grades, 7 out of 38 (18%) patients showed good grades, 12 out of 38 (32%) patients had fair grades, and 8 out of 38 (21%) patients showed poor grade.

Finally, after the follow-up of 6 months, 20 out of 38 (53%) patients showed excellent grades, 10 out of 38 (26%) patients had good grades, 5 out of 38 (13%) patients exhibited fair grades, and 3 out of 38 (8%) patients showed poor grade which is presented in [Figure 8] [Table 3].
Figure 8: Postoperative follow-up after 6 months with k-wire fixation

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Comparison of treatment by closed reduction and internal fixation with percutaneous K-wire fixation and open reduction and internal fixation with PHILOS plating

Operative time

As shown in [Table 4], patients selected for treatment by group B had a mean operative time of 103 ± 8.431. Whereas patients selected for treatment by Group A had a mean operative time of 107.86 ± 9.005. Based on present findings, present data revealed that there was a statistically significant difference between Group B and Group A in terms of operative time.
Table 4: Comparison of operative time of treatment with percutaneous K-wire fixation and PHILOS plating

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Time to union

According to the table, the mean time to union in terms of Group A and Group B was around 11.52, and 12.36, respectively. The present data imply that there was a significant difference between the time of union of treatment by Group B and by Group A statistically. Hence, Group A takes less time to unite as the P = 0.0198.

Comparison of complications after open reduction and internal fixation with PHILOS plating and closed reduction and internal fixation with percutaneous K-wire fixation

Various complications were observed among patients after treatment by Group A and Group B. In the case of Group A, out of a total of 38 patients, 2 (5%) had avascular necrosis, which was the same in the case of Group B. In Group A, only one patient had impingement, and in Group B, no impingement was observed. However, wound infection were also seen among both groups [Table 5].
Table 5: Time to union observed in the patients

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No complications were observed in 33 (87%) patients in the case of both treatments. In the case of group A there were no patients with nonunion, while in the case of Group B, 1 (2%) patient had nonunion. Malunion was not observed after Group A. 1 (2%) patient showed malunion after Group B [Table 6].
Table 6: Comparison of complications after open reduction and internal fixation with PHILOS plating and closed reduction and internal fixation with percutaneous K-wire fixation

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Shoulder constant score

Four different grades of SCS were observed after operating on patients by Group B and Group A. After treatment by Group A, out of a total of 38 patients, 20 (26%) patients showed an excellent grade of SCS, 10 (13%) patients exhibited a good grade, 5 (6%) patients had a fair grade, and 3 (4%) patients displayed a poor grade. Whereas, after treatment by Group B, 12 (16%) of 38 patients received an excellent grade, 7 (9%) received a good grade, 16 (21%) received a fair grade, and 3 (4%) received a poor grade. After comparing both treatments, a P value was found to be 0.0403, which shows Group A was more efficient than Group B [Table 7].
Table 7: Comparison of grades of shoulder constant score observed in the patients

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  Discussion Top


The current study included 76 patients from a tertiary care hospital. Patients were selected on the basis of inclusion and exclusion criteria. The current study attempted to understand the efficacy of CRIF with percutaneous K-wire fixation and ORIF with PHILOS plating on patients with two-part and three-part fractures.

In this study, 76 patients were divided into two groups, i.e., Group A and Group B, each group had 38 patients. After 6 months of follow-up, 53% of patients had excellent grades, 13% had good grades, 26% had fair grades, and 8% had poor grades after being treated by ORIF with the PHILOS plate. In the case of percutaneous K-wire fixation, 31% of patients showed excellent grades, 18% of patients had good grades, 42% of patients had fair grades, and 8% showed poor grades. These outcomes clearly showed that ORIF with PHILOS plate was more efficient than CRIF with percutaneous K-wire fixation.

The findings of the present study were similar to the study done by Singh et al.[16] They performed the comparative study on patients treated by either CRIF with percutaneous K-wire fixation or by ORIF with PHILOS plating. According to them, 50 patients were distributed into two groups containing 25 patients each. The patients of Group 1 were treated by CRIF with K-wire fixation and the patients of Group 2 were treated with ORIF with PHILOS plate. In Group 1, 7 (28%) patients had excellent results; 12 (48%) patients had satisfactory results; 2 (8%) patients had unsatisfactory results; and 4 (16%) patients had a poor outcome. In Group 2, 12 (48%) patients had excellent results; 9 (36%) patients had satisfactory results; 2 patients (8%) had unsatisfactory results; and 2 (8%) patients had a poor outcome, according to Neer's scoring system. This study showed that ORIF with PHILOS plate had superior results than CRIF with percutaneous K-wire fixation.

Another study conducted by Fazal and Haddad[17] shows that ORIF with PHILOS plate fixation provided stable fixation with minimal implant problems and enabled early ROM exercises to achieve acceptable functional results.

In this study, the major cause of fracture in our study was due to RTA. Out of 38 patients, 53% (20 out of 38) were injured due to RTA and 47% (18 out of 38) were injured due to falling in (Group A). Similarly, in (Group B) out of 38 patients, 47% (18 out of 38) were injured due to RTA, and 53% (20 out of 38) were injured due to falls. The finding of the present study is similar to a study done by, Aggarwal et al.[18] in their study of 47 patients of proximal humerus fracture accounted for 55% of fractures, RTA 42.5%, and 1 (2.5%) fracture caused by the seizure.

As said by, Jaura et al.[19] compared the outcomes of PHILOS plate versus percutaneous fixation in proximal humerus fractures in the elderly. They concluded that ORIF with the PHILOS plate had the advantage of accurate reduction. Early mobilization, improved fixation in osteoporotic patient's bones (due to the locking screws), and ease of reconstruction of comminuted irreducible fractures.

ORIF offer anatomical reduction with rigid fixation of the fracture fragments and early mobilization of the shoulder. According to a study conducted by Konrad et al.[20] ORIF of the proximal humerus fractures with the locking plate had a higher complication rate with 7.9% avascular necrosis, 11.7% screw cut out and 13.7% needed revision surgery. These complications of the locking plate can be prevented by good surgical technique.

According to a research done by Jaura et al.[19] fractures of this region are prevalent in elderly people with osteoporosis and result from both high-energy traumas and straightforward falls. Fracture patterns are complicated in elderly patients by their brittle bones. Due to their comorbid disorders, treating these people is significantly more difficult.


  Conclusion Top


Compared to ORIF with Philos plating treatment with CRIF using the K-wire fixation has poor functional outcomes and a high failure rate. We found ORIF with Philos plating is a safe system for displaced two- and three-part fractures of the proximal humerus, with good functional results. In the two-part fracture group, we did not report complications. Complication rates for three-part fractures are comparable to the other reconstructive methods reported in the literature and are more related to the age of the patients and the quality of bone rather than a specific surgery approach or fixation device. The problem of surgical indication in elderly patients is still open. We believe that these patients' treatment should be planned according to general status and functional demands.

Acknowledgments

We gratefully acknowledge the Neuron Institute of Applied Research for their generous help in editing and technical help.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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Singh CM, Singh D, Singh B, Singh M, Sreen S. Outcome of proximal humeral fracture fixation with K wires Vs Philos plating. Int J Orthopaed Traumatol Surg Sci 2020;6:18-21.  Back to cited text no. 16
    
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    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]



 

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