Proximal humerus fractures comprise 4% to 5% of all fractures.1 It  represent the most common humerus fracture. 75% of all proximal humerus fractures occur in patients older than age 60 years.2 It is the second most common upper-extremity fracture and the third most common fracture, after fractures around hip and distal radius in patients who are older than sixty  years of age.3The increased incidence in the older population is thought to be related to osteoporosis. The 2:1 female-to-male ratio is likely related to issues of bone density.4 Majority of proximal humeral fractures (85%) are either undisplaced or minimally displaced and can be treated conservatively.5 The rest 15% of these proximal humerus fractures are displaced in which,surgical intervention is required. However,the optimal surgical treatment remains controversial.6 Many surgical techniques have been described, but no single approach is considered to be the standard of care.3

A single center prospective randomized comparative study was carried out at Nalbari Medical College and Hospital in patients having displaced 3-and 4-part proximal humerus  fractures above 60 years of age attending the emergency and outpatient department. The duration of the study was 1year (July 2023 to June 2024). The patients were randomized as per the internet site, www.randomization.com to include in either surgical procedures of Proximal Humeral Internal Locking System (PHILOS) and Shoulder Hemiarthroplasty.

INCLUSION CRITERIA:

• Patients older than 60 years of age.
• Fractures within 14 days of injury.
• Closed proximal humerus fractures and dislocations (3-,4-part according to Neer’s
• Classification).
• Medically stable patients who could undergo post-operative rehabilitation.

EXCLUSION CRITERIA:

• Patients below 60 years of age.
• Proximal humerus fractures older than 14 days.
• Un-displaced proximal humeral fractures.
• Open proximal humerus fractures.
• Concomitant fracture at distal humerus or at elbow joint.
• Infection at the site of the fracture.
• Associated neurovascular injury.
• Pathological fractures of proximal humerus.
• Medically unfit for surgery.

 In total 24 patients included in the study with 16 being under the Proximal Humeral Internal Locking System (PHILOS) group and 8 under Shoulder Hemiarthroplasty group after randomization. Patients were followed up at 2 weeks, 4 weeks, 3 months, 6months and 9 months postoperatively; during which the functional outcome, patient satisfaction, quality of life, radiological evaluation and complications were assessed. Visual Analogue Score (VAS), Constant-Murley Score, Disability of Arm and Shoulder Score (DASH) were considered to evaluate the relief of shoulder symptoms and its functional outcome.

 SURGICAL TECHNIQUE:

Open reduction and internal fixation with PHILOS plate:

Surgery was performed with the patient in beach chair position. A deltopectoral approach was used with minimal soft-tissue dissection. First, the cephalic vein and deltopectoral groove were identified through a longitudinal incision .The skin incision was approximately 10-15 cm long and started at the tip of the coracoid process proximally and extending distally to the deltoid tuberosity. The deltoid was retracted laterally, and the greater tuberosity was identified. Once the skin and the subcutaneous tissues were exposed, the cephalic vein, deltoid, and pectoralis major were identified. The subdeltoid space was identified and fracture hematoma was cleared. After the identification of the long head of the biceps on the anterior aspect of the proximal shaft facilitated fracture identification and reduction and plate placement. After exposing proximal humerus, tuberosities and humeral head were reduced along with rotator cuff tendons tagged with ethibond no.5 sutures to tie to final construct. Humeral shaft, tuberosities and humeral head were temporarily fixed with K-wires. If dislocation was there it was reduced. Philos plate was put lateral to bicipital groove and 8-10mm distal to the tip of greater tuberosity. It was further confirmed by fluoroscopic images.

Shoulder Hemiarthroplasty :

Surgery was performed with the patient in beach chair position. An extensile deltopectoral approach was used (from inferior border of clavicle, across the coracoid process to deltoid tuberosity). Significant adhesions and hematoma were  removed from the subdeltoid space. The bicipital groove was used as a critical landmark. The fracture line between the tuberosities, was most of the times located just posterior to the groove. The partial rotator cuff tears which were encountered were repaired using vicryl sutures. In the first part of the procedure, care was taken in getting control of the tuberosity fragments. In cases of three-part fractures, osteotomy of the lesser tuberosity from the humeral head was done, which served in creating a four-part fracture.  The humeral head, after removal, tuberosities were tagged with heavy sutures   (Ethibond no.5).  Sutures were placed, one at the bone–tendon interface of the greater tuberosity, and two at the lesser tuberosity fragment. After exposure of the humeral canal, it was prepared with sequential reaming. The height of the stemmed prosthesis, placed 5-6cm proximal to the superior border of pectoralis major tendon  and 20°–30°  of retroversion taking transepicondylar axis as reference. Closed reduction with a trial head was performed to assess the stability of the prosthesis. In our procedure, around 40-50 % translation of the head on the glenoid in the anterior, posterior, and inferior directions was preferred. After cement placement, the final humeral head component was placed. Fixation of the tuberosity to tuberosity, tuberosity to implant and tuberosity to shaft was ensured with minimum tension.. The bone graft obtained from the fractured head was packed and placed between the interstices of the tuberosity and shaft.

POST-OPERATIVE CARE AND REHABILITATION:

After surgery in the either operative procedures, the involved shoulder was kept in Universal Shoulder Immobiliser and continued for 3-4 weeks, which was put off during shoulder exercises. On the day after surgery, hand, wrist and elbow movements were encouraged.Shoulder pendulum exercises was started on first post-op day as per patients’ tolerance. Passive forward elevation and abduction started from 5^th post-op day, while passive external and internal rotation encouraged from 4^th post op week, with active shoulder exercises from 6^th post-op week. Stretching exercises and resistive training exercises of the shoulder carried out at 8^th post-op week and 12^th post-op week respectively.

The maximum numbers of patients were observed between 61-65 years (54.17%) in both surgical groups with a mean age of 65.12 years. There was female preponderance (62.5%) in the study group with maximum of the cases due to low energy fall from erect posture ( 65%).Maximum of the fractures(60%) were of 3-part fractures as per Neer’s classification. The  operative time for PHILOS group ranged from 79.56+7.22 minutes as compared to Shoulder Hemiarthroplasty having 98.48+7.8 minutes(p<0.05,which is statistically significant).The  radiological union time for PHILOS group was 15.8+ 5 weeks whereas Hemiarthroplasty took 18.8+3.4 weeks(p>0.05,insignificant). The mean amount of blood loss in the PHILOS group was 160.94 ml and in Shoulder Hemiarthroplasty group was 181.88 ml, considered statistically insignificant. Overall, average hospital stay of the studied group was 9.41 days. The mean forward flexion, extension,abduction,external and internal rotation of the shoulder joint in PHILOS group was 127.18° , 45.33° , 107.1°, 56.93°  and 45.93° respectively  whereas in the Shoulder Hemiarthroplasty group mean forward flexion, extension,abduction,external and internal rotation of the shoulder joint of 80°, 33.37°, 81.2°, 30.25° and 38.87° respectively; with significant difference(P<0.05) favoring the PHILOS group in terms of forward flexion, abduction and external rotation. The mean Constant Murley score for PHILOS group was 72.25 considered as Good and for Shoulder Hemiarthroplasty was 64.12 considered as Moderate showing no statistical significance between the groups. The DASH score for PHILOS group was 19.75 (Excellent) and for Shoulder Hemiarthroplasty was 25.62 (Good) with both the scores showing no statistical significance (P>0.05) but however with better outcome for the PHILOS surgical group. The mean VAS score for Shoulder Hemiarthroplasty group was 3.75  and that for PHILOS group was 4.5 at last follow up, which is not statistically significant,(P>0.05).

In this study, out of 16 cases operated with Open reduction and internal fixation with PHILOS, total 37.5% (6 cases) developed complications. There were 2 (12.5%) shoulder stiffness , 1 (6.25%) malreduction, 1 (6.25%) partial avascular necrosis of humeral head, 1 (6.25%) subacromial screw impingement and the other 1 (6.25%) varus malunion which were of 4-part fracture, causing poor functional outcomes.In the Shoulder Hemiarthroplasty group, 25% (2 cases) had complications. 1 (12.5%) had superficial infection and the remaining 1 ( 12.5%) had tuberosity resorption, resulting in poor functional outcome and patient dissatisfaction.

TABLE: Showing different complications, its number and percentage under the two surgical procedures

Proximal humerus fracture constitutes for 2-3% of fractures of upper limb. Incidence of these fractures are 73 per one lakh population & 75% of these fractures are seen in elderly.7,8  We have undertaken the study of significantly displaced more complex fractures that are Neer's type  2 (3-part) and type 3 (4-part) because increase incidence of these fractures in last few decades.

Many studies have shown that the displaced fractures of the proximal humerus have poor functional outcome when left untreated or conservatively managed with plaster cast because of severe  comminution & displacement of fragments.9,10 Due to awareness of its complexity and complication,   these fractures have stimulated a growing interest in finding the optimal treatment. An adequate    anatomical reduction and early rehabilitation is a strong predictor for good functional outcome.11,12

Selecting and executing a treatment option for complex proximal humerus fractures remains a significant challenge, as universally accepted guidelines for treatment modality have not been established. While indications for hemiarthroplasty are not absolute, it has been recommended for patients with osteoporosis, severe comminution, head splitting fractures, and fractures with a high probability of osteonecrosis.13, 14Many authors favor primary hemiarthroplasty for complex proximal humerus fractures because it is successful in providing pain relief and is often considered less technically demanding than ORIF. Unfortunately, functional results of hemiarthroplasty have been disappointing. 15Zyto et al 16reviewed 27 patients after a mean of 3 years who had sustained displaced 3- and 4-part fractures of the proximal humerus treated with hemiarthroplasty; mean Constant Score was 56 (range, 11-78), median ROM was 70° of flexion and abduction, and 9 patients had moderate or severepain. Kralinger et al13 found that after hemiarthroplasty, the outcome was generally satisfactory in regard to pain, but only 41.9% of patients were able to flex the shoulder >90° .

Our results with hemiarthroplasty are comparable to those in the literature. Our patients treated with hemiarthroplasty had effective relief of their pain comparable to that of ORIF. However, they had decreased ROM, with forward elevation and abduction means of 80° and 81.2°respectively. They also had difficulty with many functional tasks, as illustrated by a DASH score of 25.6 and a mean Constant score of 64.12. Reasons cited for  moderate to poor functional outcome include poor rotator cuff integrity, advanced age, difficulty with tuberosity healing, limited ROM, difficulty in soft tissue balancing, and component malposition.17,18

Although no panacea for this difficult fracture exists, ORIF with locked plating has regained popularity as an attractive alternative to hemiarthroplasty. In a study, Duralde and Leddy 19prospectively explored the results of locking-plate ORIF in unstable fractures. They had a good to excellent result in 82% of patients with an average forward elevation of 136°. They attributed their good results to anatomic reduction, careful soft tissue technique, and suture-augmentation of the repair with Fiber-Wire sutures through the rotator cuff and tied around the plate. There was no recorded screw penetration and only 1 case of avascular necrosis. Our results are comparable with the recent literature with an average DASH score of 19.75, an average Constant Score of 72.25, and average forward elevation of 127.18° and abduction of 107.1°. However with complications like avascular necrosis of humeral head, varus malunion and malreduction in complex fracture-dislocation leads us to think of a salvage procedure like Hemiarthroplasty which could give optimum functional shoulder in such selected cases.

Proximal Humeral Internal Locking System (PHILOS) yields a more functional, pain free shoulder with proper care if taken for anatomical reduction and fixation of tuberosities and hardware placement    intraoperatively. However in osteoporotic bone and in fractures with higher degree of comminution (4-part fractures and dislocation),it may lead to  complications, later requiring the hardware removal and secondary procedures. Shoulder Hemiarthroplasty can serve as a salvage procedure in failure of PHILOS or in cases with severely osteoporotic bone, in fractures where avascular necrosis of humeral head is imminent   and where acceptable reduction cannot be obtained. In Shoulder hemiarthroplasty, tuberosity reduction and its union play a significant role in functional outcome. It gives a shoulder with optimal functional outcome, sufficient enough for this elderly population.

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