The clinical benefit of medial support screws in locking plating of proximal humerus fractures: a prospective randomized study. [Surgical treatment for proximal humerus fracture]. Primary hemiarthroplasty in four-part fractures of the proximal humerus: randomized trial of two different implant systems. Immediate mobilization compared with conventional immobilization for the impacted nonoperatively treated proximal humeral fracture. A randomized controlled trial. Internal fixation versus nonoperative treatment of displaced 3-part proximal humeral fractures in elderly patients: a randomized controlled trial. Are polyaxially locked screws advantageous in the plate osteosynthesis of proximal humeral fractures in the elderly? A prospective randomized clinical observational study. Transcutaneous reduction and external fixation of displaced fractures of the proximal humerus. A controlled clinical trial. A multicenter, prospective, randomized, controlled trial of open reduction--internal fixation versus total elbow arthroplasty for displaced intra-articular distal humeral fractures in elderly patients. [Prosthetic humeral head replacement in dislocated humerus multi-fragment fracture in the elderly--an alternative to minimal osteosynthesis?].
The purpose of this study was to evaluate the clinical benefit of medial support screws for locking plating of proximal humerus fractures.
                Seventy-two consecutive patients underwent prospective treatment for proximal humerus fractures with locking plates between October 2007 and September 2008. Sixty-eight patients accomplished a mean 30.8-month follow-up and were randomized into two groups: 39 patients were treated with only a locking plate and were classified in the -MSS (medial support screw) group, and 29 patients were included in the + MSS group, which were fixed with additional medial support screws. Clinical and radiological investigations were performed in both groups.
                The fractures united at an average of 13.6 weeks after final surgery. Comparably better shoulder function recovery was achieved in the +MSS group with regard to the Constant shoulder score (P = 0.01), with the respective excellent and good rates of 79% and 62%. Eleven patients developed various complications. A statistical difference (P = 0.036) was observed regarding the failure rate (23.1% in the -MSS group vs. 3.4% in the +MSS group). The early loss of fixation was related to higher age (P < 0.001) and less initial neck-shaft angle (NSA) (P = 0.011) of the patients. However, bone mineral density was not significantly associated with loss of fixation (P = 0.076). Although no difference was found in all types of the fractures between the +MSS and -MSS groups regarding immediate postoperative NSA, we observed a significantly lower final NSA in the -MSS group and greater secondary angle loss in the subgroup of Neer three-part (P = 0.033 and 0.015, respectively) and four-part fractures (P = 0.043 and 0.027).
                Anatomical reduction can substantially decrease the risk of postoperative failure in locking plating of proximal humerus fractures. Medial support for proximal humerus fractures seems to have no benefits in Neer two-part fractures. However, the additional medial support screws inserted into the medio-inferior region of the humeral head may help to enhance mechanical stability in complex fractures and allow for better maintenance of reduction. The aim of the study was to compare the medical aspects of alternative surgical methods for treatment of proximal humerus fractures in specific indications (two- and three- fragment fractures).
                A prospective randomised study on surgical treatment of two- and three-fragment fractures of the proximal humerus was carried out at the Department of Surgery, University Hospital in Hradec Králové, from January 2006 till January 2010. The study comprised patients with proximal humerus fractures indicated for surgical treatment. Study inclusion criteria were as follows: informed consent, AO fracture types A2, A3, B1 or C1, age between 18 and 80 years, and patient compliance. Exclusion criteria included open fracture, associated injury (AIS . 2), open growth plates, or such state of the patient's health that would limit the extent of surgery. Two groups were compared. One included patients treated by the Zifko method of minimally invasive osteosynthesis with intramedullary K-wire insertion (MIO group) and the other (ORIF group) consisted of patients undergoing open reduction with angle-stable osteosynthesis using a Philos plate (Synthes, Switzerland). The patients were randomised to the groups by a computer programme which facilitates the maintenance of homogeneity of the groups compared. The procedure in each patient was based on the sealed-envelope method.
                The ORIF group comprised 28 patients. It took them an average of 27.2 weeks (9-72) to regain normal upper limb function. The final CM score was 86.6% (64-100%) as compared with the healthy limb. Excellent and good results were achieved in 89% of the patients; complications were recorded in 39% of them. The MIO group included 27 patients. The fractures healed in all of them. Normal upper limb function was regained at an average of 21.4 weeks (13-36). The final CM score was 87.5% (52-100%) in comparison with the healthy limb. Excellent and good results were achieved in 89% and complications developed in 33% of the patients.
                The statistical evaluation of the results, using the unpaired t-test, did not show any significant differences either in functional outcomes or the number of complications between the two groups. The only significant difference was found in operative times (117 min and 72 min in ORIF and MIO groups, respectively). The difference in time needed to regain limb function (27 and 21 weeks) was at a marginal level of statistical significance. With both methods 89% of excellent and good results were achieved, and a similar number of patients had complications (11 and 9). The objective of this study was to determine the effect of different prosthetic systems on the functional and radiographic outcomes after shoulder arthroplasty for fractures. This study comprised 35 patients (28 women and 7 men) with a mean age of 74 years (range, 56-88 years) who sustained 4-part fractures of the proximal humerus and were randomly allocated to 2 different groups regarding the type of prosthesis. The 2 systems used differ mainly in the type of fixation of the tuberosities. In group 1 (EPOCA), the fixation was achieved with wire cables through a medial and a lateral hole in the stem, whereas in group 2 (HAS), the fixation was performed by use of transosseous braided sutures. After a follow-up of 1 year, the functional and radiographic outcomes were evaluated. The retrieved data demonstrate that rigid fixation and anatomic positioning of the tuberosities (group 1) increase the rate of bony healing superior to all other factors. There was a statistically significant difference regarding the relative individual Constant score (P = .001) and the mean active range of motion (flexion, P < .001; abduction, P = .001; external rotation in adduction, P = .01; and external rotation in 90 degrees abduction, P = .001) when both groups were compared, showing a better outcome in the EPOCA group for all parameters. Radiologic findings, like heterotopic ossification, glenoid erosion, or subluxation, had no significant influence on the outcome in this study. Accurate placement of the tuberosities and healing at the bone-bone interface of the rotator cuff seem to be the most important factors influencing the outcome in prosthetic care of fractures. There have been few randomized controlled trials evaluating nonoperative treatment of proximal humeral fractures. To investigate shortening the period of dependence, we assessed the feasibility and efficacy of early mobilization of the shoulder (within three days after the fracture) in comparison with those of conventional three-week immobilization followed by physiotherapy.
                We randomly assigned seventy-four patients with an impacted proximal humeral fracture to receive early passive mobilization or conventional treatment. The primary outcome was the overall shoulder functional status (as measured with the Constant score) at three months. The secondary outcomes were the Constant score at six weeks and at six months, the change in pain (on a visual analog scale), and the active and passive range of motion.
                At three months and at six weeks, the early mobilization group had a significantly better Constant score than did the conventional-treatment group (between-group difference, 9.9 [95% confidence interval, 1.9 to 17.8] [p = 0.02] and 10.1 [95% confidence interval, 2.0 to 18.1] [p = 0.02], respectively) and better active mobility in forward elevation (between-group difference, 12.0 [95% confidence interval, 1.7 to 22.4] [p = 0.02] and 28.1 [95% confidence interval, 7.1 to 49.1] [p = 0.01], respectively). At three months, the early mobilization group had significantly reduced pain compared with the conventional-treatment group (between-group difference, 15.7 [95% confidence interval, 0.52 to 30.8] [p = 0.04]). No complications in displacement or nonhealing were noted.
                Early mobilization for impacted nonoperatively treated proximal humeral fractures is safe and is more effective for quickly restoring the physical capability and performance of the injured arm than is conventional immobilization followed by physiotherapy. The aim of the study was to report the 2-year outcome after a displaced 3-part fracture of the proximal humerus in elderly patients randomized to treatment with a locking plate or nonoperative treatment.
                We included 60 patients, mean age 74 years (range, 56-92), 81% being women. The main outcome measures were the Constant and Disabilities of the Arm, Shoulder and Hand (DASH) scores and the health-related quality of life (HRQoL) according to the EQ-5D.
                At the final 2-year follow-up, the results for range of motion (ROM), function and HRQoL were all in favor of the locking plate group. The mean flexion in the locking plate group was 120° compared to 111° in the nonoperative group (P = .36) and the mean abduction was 114° compared to 106° (P = .28). The corresponding values for the Constant score were 61 versus 58 (P = .64), for DASH 26 versus 35 (P = .19), and the mean EQ-5D (index) score was 0.70 compared to 0.59 (P = .26). In spite of good primary reduction in 86% of the fractures in the locking plate group, 13% of the patients had a fracture complication requiring a major reoperation and 17% had a minor reoperation.
                The results of our study indicate an advantage in functional outcome and HRQoL in favor of the locking plate compared to nonoperative treatment in elderly patients with a displaced 3-part fracture of the proximal humerus, but at the cost of additional surgery in 30% of the patients.
                Copyright © 2011 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved. To evaluate the results of plate osteosynthesis using either polyaxial or nonpolyaxially locked screw-plate systems in proximal humeral fractures in the elderly.
                Prospective, randomized.
                Level I trauma center.
                Fifty-six patients (older than 60 years) with isolated, displaced three- and four-part fractures were included. Twenty-five patients (median age, 75.5 years) were randomized to a polyaxial locking screw plate (Group 1), whereas 31 patients (median age, 72 years) were treated with a locking screw plate (Group 2). Follow-up evaluations were performed 3, 6, and 12 months postoperatively using the Simple Shoulder Test, Disabilities of the Arm, Shoulder and Hand score, and Constant score as well as radiographs. The results and the complications were compared between both groups.
                Forty-eight patients were available for follow-up (Group 1, 20 of 25; Group 2, 28 of 31). The Simple Shoulder Test, Disabilities of the Arm, Shoulder and Hand, and Constant score improved significantly from 3 to 12 months and did not differ between groups. Twelve months after the index procedure, the Simple Shoulder Test score was 8.6 ± 3.2 points in Group 1 and 9.7 ± 1.8 points in Group 2. The Disabilities of the Arm, Shoulder and Hand score was 17.8 ± 16.2 in Group 1 and 15.7 ± 11.8 in Group 2. The mean Constant score amounted to 73% ± 17% in Group 1 and 81% ± 13% in Group 2. There were six complications in Group 1 and eight in Group 2.
                Both the functional outcomes and the rate of complications after polyaxial locked plate osteosynthesis of proximal humeral fractures in elderly patients were comparable to those treated with nonpolyaxial implants. Despite the theoretical advantages of polyaxial locked plating in proximal humerus fractures, this study could not show a verifiable clinical advantage of these plates. A consecutive series of 31 displaced fractures of the proximal humerus were randomly selected for treatment either by closed manipulation or by transcutaneous reduction and external fixation. Follow-up assessed the quality of reduction and healing as well as the functional outcome. The external fixation method gave better reduction, safer healing and superior function. We conducted a prospective, randomized, controlled trial to compare functional outcomes, complications, and reoperation rates in elderly patients with displaced intra-articular, distal humeral fractures treated with open reduction-internal fixation (ORIF) or primary semiconstrained total elbow arthroplasty (TEA). Forty-two patients were randomized by sealed envelope. Inclusion criteria were age greater than 65 years; displaced, comminuted, intra-articular fractures of the distal humerus (Orthopaedic Trauma Association type 13C); and closed or Gustilo grade I open fractures treated within 12 hours of injury. Both ORIF and TEA were performed following a standardized protocol. The Mayo Elbow Performance Score (MEPS) and Disabilities of the Arm, Shoulder and Hand (DASH) score were determined at 6 weeks, 3 months, 6 months, 12 months, and 2 years. Complication type, duration, management, and treatment requiring reoperation were recorded. An intention-to-treat analysis and an on-treatment analysis were conducted to address patients randomized to ORIF but converted to TEA intraoperatively. Twenty-one patients were randomized to each treatment group. Two died before follow-up and were excluded from the study. Five patients randomized to ORIF were converted to TEA intraoperatively because of extensive comminution and inability to obtain fixation stable enough to allow early range of motion. This resulted in 15 patients (3 men and 12 women) with a mean age of 77 years in the ORIF group and 25 patients (2 men and 23 women) with a mean age of 78 years in the TEA group. Baseline demographics for mechanism, classification, comorbidities, fracture type, activity level, and ipsilateral injuries were similar between the 2 groups. Operative time averaged 32 minutes less in the TEA group (P = .001). Patients who underwent TEA had significantly better MEPSs at 3 months (83 vs 65, P = .01), 6 months (86 vs 68, P = .003), 12 months (88 vs 72, P = .007), and 2 years (86 vs 73, P = .015) compared with the ORIF group. Patients who underwent TEA had significantly better DASH scores at 6 weeks (43 vs 77, P = .02) and 6 months (31 vs 50, P = .01) but not at 12 months (32 vs 47, P = .1) or 2 years (34 vs 38, P = .6). The mean flexion-extension arc was 107 degrees (range, 42 degrees -145 degrees) in the TEA group and 95 degrees (range, 30 degrees -140 degrees) in the ORIF group (P = .19). Reoperation rates for TEA (3/25 [12%]) and ORIF (4/15 [27%]) were not statistically different (P = .2). TEA for the treatment of comminuted intra-articular distal humeral fractures resulted in more predictable and improved 2-year functional outcomes compared with ORIF, based on the MEPS. DASH scores were better in the TEA group in the short term but were not statistically different at 2 years' follow-up. TEA may result in decreased reoperation rates, considering that 25% of fractures randomized to ORIF were not amenable to internal fixation. TEA is a preferred alternative for ORIF in elderly patients with complex distal humeral fractures that are not amenable to stable fixation. Elderly patients have an increased baseline DASH score and appear to accommodate to objective limitations in function with time. In a prospective randomised study, comprising 30 aged patients with fractures of the proximal humerus (4-fragment fractures according to Neer) minimal osteosynthesis was compared to primary endoprosthetic replacement. The Constant score was used for evaluation during follow-up. After one year the results were similar in both groups. There were two complications necessitating revision surgery among the patients with minimal osteosynthesis and in four cases the implants had to be removed. In the group with primary endoprosthetic repair neither complications nor revision surgery occurred. Primary endoprosthetic replacement for the treatment of proximal humeral fractures appears as a therapeutic option with a low complication rate and a satisfying functional outcome. In older patients we need a safe mode of therapy permitting early mobilization and quick discharge from the hospital back to the patient's home. Endoprosthetic replacement fulfils these demands since it resembles a "one time surgery" without the risk of revision surgery for implant loosening, pseudarthrosis or ischemic necrosis of the humeral head.
Overall, this review found there is either no or insufficient evidence from randomised or quasi-randomised controlled trials to determine whether surgery is, and which surgical interventions are, the most appropriate for the management of different types of distal humerus fractures. Well designed and reported large and multi-centre randomised controlled trials testing current interventions, such as pre-contoured and locking plating systems, are needed.