One and two-year clinical outcomes for a polyethylene glenoid with a fluted peg: one thousand two hundred seventy individual patients from eleven centers.

PURPOSE: Clinical shoulder science lacks a benchmark against which the early clinical value of new glenoid components can be compared; such a benchmark may be derived from a multicenter study of patients receiving an established, internationally used design of glenoid component. METHODS: We obtained data from 11 centers on 1270 patients having total shoulder arthroplasty using an all-polyethylene component with a fluted central peg. We analyzed individual patient outcomes at 1 and 2 years after surgery. We compared the improvement for each patient to the minimal clinically important difference (MCID) and calculated each patient's improvement as a percent of maximal possible improvement (MPI). RESULTS: The preoperative scores improved from SST 3 ± 2, ASES 37 ± 15, Constant score 36 ± 16, and Penn score 30 ± 19 to SST 10 ± 2, ASES 90 ± 12, Constant 76 ± 13, and Penn 80 ± 24 (p < 0.001 for each). A high percentage of patients improved by more than the MCID (SST 96%, ASES 98%, Constant 94%, Penn 93%) and obtained improvement of at least 30% of the MPI (SST 95%, ASES 98%, Constant 91%, Penn 87%). The clinical outcomes realized with this glenoid design were not worse for the 41% of shoulders with preoperative type B glenoids or for the 30% of shoulders with more than 15 degrees of glenoid retroversion. CONCLUSIONS: Individual patients from 11 international practices having total shoulder arthroplasty using a basic glenoid component design obtained highly significant clinical outcomes, providing a benchmark against which the early outcomes of new designs can be compared to determine whether they provide increased clinical value.

Clinical and Radiographic Outcomes of the Simpliciti Canal-Sparing Shoulder Arthroplasty System: A Prospective Two-Year Multicenter Study.

BACKGROUND: Stemmed humeral components have been used since the 1950s; canal-sparing (also known as stemless) humeral components became commercially available in Europe in 2004. The Simpliciti total shoulder system (Wright Medical, formerly Tornier) is a press-fit, porous-coated, canal-sparing humeral implant that relies on metaphyseal fixation only. This prospective, single-arm, multicenter study was performed to evaluate the two-year clinical and radiographic results of the Simpliciti prosthesis in the U.S. METHODS: One hundred and fifty-seven patients with glenohumeral arthritis were enrolled at fourteen U.S. sites between July 2011 and November 2012 in a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE)-approved protocol. Their range of motion, strength, pain level, Constant score, Simple Shoulder Test (SST) score, and American Shoulder and Elbow Surgeons (ASES) score were compared between the preoperative and two-year postoperative evaluations. Statistical analyses were performed with the Student t test with 95% confidence intervals. Radiographic evaluation was performed at two weeks and one and two years postoperatively. RESULTS: One hundred and forty-nine of the 157 patients were followed for a minimum of two years. The mean age and sex-adjusted Constant, SST, and ASES scores improved from 56% preoperatively to 104% at two years (p < 0.0001), from 4 points preoperatively to 11 points at two years (p < 0.0001), and from 38 points preoperatively to 92 points at two years (p < 0.0001), respectively. The mean forward elevation improved from 103° ± 27° to 147° ± 24° (p < 0.0001) and the mean external rotation, from 31° ± 20° to 56° ± 15° (p < 0.0001). The mean strength in elevation, as recorded with a dynamometer, improved from 12.5 to 15.7 lb (5.7 to 7.1 kg) (p < 0.0001), and the mean pain level, as measured with a visual analog scale, decreased from 5.9 to 0.5 (p < 0.0001). There were three postoperative complications that resulted in revision surgery: infection, glenoid component loosening, and failure of a subscapularis repair. There was no evidence of migration, subsidence, osteolysis, or loosening of the humeral components or surviving glenoid components. CONCLUSIONS: The study demonstrated good results at a minimum of two years following use of the Simpliciti canal-sparing humeral component. Clinical results including the range of motion and the Constant, SST, and ASES scores improved significantly, and radiographic analysis showed no signs of loosening, osteolysis, or subsidence of the humeral components or surviving glenoid components. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Stemless shoulder arthroplasty-current results and designs.

Stemless shoulder arthroplasty was originally introduced in 2004 by a single manufacturer. Now, over a decade later, numerous designs are available outside the USA, but as yet, only one implant has been cleared by the Food and Drug Administration (FDA) and is available for use within the USA. Often referred to as "canal sparing," these implants are designed for metaphyseal fixation to minimize humeral bone removal, avoid intraoperative and postoperative humeral fracture complications, and to decrease morbidity associated with revision operations. Recently, the second generation of stemless arthroplasty, a convertible implant allowing use in either anatomic or reverse arthroplasty configuration, was released for use outside the USA. This paper will review the available designs, reported results, and raise potential concerns for this emerging technology.

Quantification of B2 glenoid morphology in total shoulder arthroplasty.

BACKGROUND: B2 glenoid morphology is challenging to address with shoulder reconstruction. Deformity often renders current techniques inadequate, necessitating compromises that limit long-term implant durability. The purpose of this study was to perform in vivo measurements of glenoid deformity to better appreciate the orientation of the B2 biconcavity demarcation and erosion that surgeons face intraoperatively. MATERIALS AND METHODS: A consecutive 106 total shoulder arthroplasty cases for primary glenohumeral osteoarthritis were studied. We classified glenoids by direct visualization and noted lines of biconcavity demarcation and erosion in B2s. We then calculated the "angle of erosion" as that between the back side of the unsupported, smooth-backed glenoid sizer disk and the neoglenoid. We obtained depth measurements throughout the reaming process and monitored subchondral bone. RESULTS: We classified 43 of 106 glenoids (41%) as B2. A biconcavity demarcation line between the paleoglenoid and the neoglenoid was present, on average, from the 1-o'clock to the 7-o'clock position for a left shoulder. Mean depth of erosion was 4.4 mm, occurring at 114° on a Cartesian coordinate system for a left shoulder. The mean angle of erosion was 18° (range, 8°-43°). Despite reaming, 20 of 43 B2 glenoids (47%) had incompletely supported components at final seating. CONCLUSIONS: Arthritic B2 glenoids are common, and their maximal erosion is usually posteroinferior. Use of standard glenoid components to reconstruct them may require significant subchondral bone removal to achieve complete bone support. Alternatively, as a compromise, maintenance of subchondral bone in these cases requires implanting components with incomplete bony support.

Stemless shoulder arthroplasty: current status.

BACKGROUND: Since the original Neer humeral replacement in the 1950s, the standard primary anatomic total shoulder arthroplasty design has slowly evolved. Most recently, the humeral stem has become progressively shorter to help combat stem-related complications. Currently, there are several companies who have developed and marketed a stemless humeral arthroplasty component. MATERIALS AND METHODS: Manufacturers' data for 5 stemless shoulder arthroplasty components currently on the market were analyzed and reviewed. A literature review of short-term results for stemless shoulder arthroplasty was completed. RESULTS: Of the stemless shoulder arthroplasty systems available on the market, 3 are currently undergoing clinical trials in the United States. The Tornier Simpliciti (Tornier, Edina, MN, USA) clinical trial began in 2011. The study with 2-year minimum follow-up results is scheduled for completion in November 2014. The Arthrex Eclipse (Arthrex, Naples, FL, USA) clinical trial was started in January 2013. The tentative study completion date is 2017. The Biomet Nano (Biomet, Warsaw, IN, USA) clinical trial began in October 2013 and also has a tentative completion date of 2017. No other clinical trial is currently under way in the United States. Early results for stemless shoulder arthroplasty indicate clinical results similar to standard stemmed shoulder arthroplasty. Radiographic analysis indicates implant stability without migration or subsidence at 2- to 3-year minimum follow-up.. CONCLUSIONS: Several stemless shoulder arthroplasty implants are available outside the United States. Early clinical and radiographic results are promising, but well-designed clinical studies and midterm results are lacking. Three clinical trials are currently under way in the United States with initial availability for use anticipated in 2015.

Post-treatment glenoid classification system for total shoulder arthroplasty.

BACKGROUND: Over the past 10 years, numerous advancements in glenoid preparation and resurfacing have occurred. Current glenoid classification systems are either focused solely on the patient's preoperative glenoid bone configuration or on the available glenoid bone stock in revision arthroplasty cases. While these systems provide value in preoperative planning, they fail to properly classify the surgical reconstruction completed. METHODS: A literature review of common bone preparation methods and sources of glenoid prosthetic failure was performed. Based upon this review, a classification system for grading the status of the glenoid after prosthetic implantation was developed. RESULTS: A 6 category, post-treatment, glenoid classification system is proposed: type 0: no reaming; type I: glenoid reaming into but not through the subchondral bone; type II: glenoid reaming which perforates through <50% of the subchondral bone surface area; type III: glenoid reaming which perforates through >50% of the subchondral bone surface area; type IV: use of structural bone graft; and type V: use of a posterior augmented glenoid prosthesis. Types I-III are further subdivided into subtype A which have 100% bone support of the prosthesis, and subtype B which have a region of unsupported prosthesis. DISCUSSION: The classification system proposed addresses the surgical management of the glenoid during prosthetic replacement. This unique approach to classifying the glenoid following surgical intervention will allow direct follow-up comparison of similarly treated glenoid replacements. Future multicenter studies, possibly through joint registry databases, could then determine the long-term efficacy of the various glenoid preparation methods.

Clinical and radiographic analysis of a partially cemented glenoid implant: five-year minimum follow-up.

HYPOTHESIS: This study reviewed 20 consecutive shoulders that underwent total shoulder arthroplasty with a partially cemented glenoid component at a minimum follow-up of 5 years. We hypothesized that bone growth between the fins of the component would result in improved glenoid fixation and reduced lucent line formation. METHODS: Patients were evaluated with the Simple Shoulder Test (SST), Constant scores, and radiographs. Postoperative radiographs taken at 6 weeks and 5 years were compared. Independent evaluators assigned every glenoid a lucency grade from 0 (no lucency) to 5 (gross lucency) and assessed the central peg for bone presence between the fins. RESULTS: Mean SST and Constant scores were 11.1 and 82.4, respectively. Mean lucency scores increased from 0.1 to 0.3 from 6 weeks to the 5-year follow-up (P = .05). At the 5-year follow-up, 15 of 20 patients had similar or increased bone presence between the central peg fins, and none had a worsening lucency score. The 5 patients with decreased or absent bone presence had worsening lucency scores, from a mean of 0.2 to 1.0 (P = .05). There was no difference in SST score (P = .54) or Constant score (P = .37) between the two groups. CONCLUSIONS: This partially cemented glenoid component had low rates of lucency at the 5-year follow-up. Similar or increased bone growth between the fins of the central peg was associated with no progression of glenoid lucencies. Decreased or absent bone presence between the fins at follow-up correlated with slight advancement of glenoid lucent lines.

Total cost and operating room time comparison of rotator cuff repair techniques at low, intermediate, and high volume centers: mini-open versus all-arthroscopic.

BACKGROUND: The objective of this study was to determine mean cost and operative time differences between mini-open and all-arthroscopic rotator cuff repair techniques at surgical centers of low, intermediate, and high annual rotator cuff repair volume. METHODS: The 2006 New York State Ambulatory Surgery Database (NY-SASD) was utilized. It represents 100% of all outpatient procedures performed in hospital-affiliated and freestanding surgical centers, containing 10,658,923 patients for 2006 alone. Only patients who had an arthroscopic acromioplasty and either open or arthroscopic rotator cuff repair were included, leaving 5,224 patients for the study. These were divided into 2 groups: the mini-open group (1,334) and the all-arthroscopic group (3,890). Surgical center volume data were divided into 3 groups: low volume (<75 rotator cuff repairs per year), intermediate volume (75-199 rotator cuff repairs per year), and high volume (200+ rotator cuff repairs per year). RESULTS: Patient age and gender were normally distributed within the 2 groups with no significant differences between them (P = .82 and P = .31, respectively). Operative time was significantly shorter in the mini-open group (103 minutes) compared to the all-arthroscopic group (113 minutes), P < .00001. Surgical charges were also significantly less in the mini-open group ($7,841) compared to the all-arthroscopic group ($8,985), P < .00001. Regardless of the repair method, high volume surgical centers were significantly more expensive when compared to low and intermediate volume centers, P < .00001. CONCLUSION: The mini-open rotator cuff repair technique requires significantly less operative time and is significantly less expensive than the all-arthroscopic repair. Regardless of the repair technique, high volume surgical centers cost significantly more than low and intermediate volume surgical centers.

Elective shoulder arthroplasty in patients older than ninety years of age.

This study examined the outcome of elective shoulder arthroplasty for glenohumeral osteoarthritis or rotator cuff arthropathy in patients aged older than 90 years. The study included 7 shoulders in 6 patients with an average age of 93 years 5 months, (range, 91 years 0 months to 97 years 4 months). Average follow-up was 2.2 years, (range, 1-4 years). Preoperative range of motion, Simple Shoulder Test (SST) scores, and Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36) scores were obtained and compared with postoperative values at 3 and 6 months and yearly thereafter. Average forward elevation improved from 87 degrees to 137 degrees (P < .00001), and external rotation to the side improved from 0 degrees to 50 degrees (P < .0001). The SST scores improved from a preoperative average of 2.0 to 6.1 at 3 months (P < .0001), 6.9 at 6 months (P < .0001), 8.0 at 1 year (P < .00001), and 7.4 at 2 years (P < .0001). Significant improvements occurred in 6 of 8 SF-36 domains: Mental Health (P < .05), Vitality (P < .01), Role limitations due to emotional problems (P < .05), Social Function (P < .001), Role limitations due to physical health (P < .001), and Comfort (P < .00001). No patient had worse pain or function postoperatively. These data suggest that elective shoulder arthroplasty can be performed in patients 90 years of age and older, providing excellent pain relief, improved functional outcome, and enhanced general health status.

Humeral component modularity may not be an important factor in the outcome of shoulder arthroplasty for glenohumeral osteoarthritis.

We examined the outcomes of using 3 types of humeral prostheses in total shoulder arthroplasty for osteoarthritis: a modular prosthesis with variable head diameters (MV), a nonmodular prosthesis with variable head diameters (NV), and a nonmodular prosthesis with a fixed head diameter (NF). Patients (N=101) completed self-assessments of shoulder function and health status before surgery and at follow-up between 30 and 60 months after surgery. Outcomes for the MV and NV prostheses did not differ statistically. The NF prosthesis trended toward poorer functional scores. Two Short Form-36 dimensions were statistically significantly lower (P<.05) in the NF group than in the MV and NV groups. These results fail to confirm that humeral component modularity is an important factor in the outcome of shoulder arthroplasty.

Glenoid cementing may generate sufficient heat to endanger the surrounding bone.

Glenoid loosening is a common complication of shoulder arthroplasty. One possible cause is bone necrosis from the exothermic reaction of polymethylmethacrylate. The relationship between the amount of cement used in glenoid fixation and the risk of thermal injury to bone was examined. Glenoid arthroplasty was done on 17 fresh cadaver scapulas, recording the amount of cement used. The bone surface temperature during cement curing was measured using infrared thermography. Using these data and published thresholds for thermal necrosis, the frontal plane area of bone that would be at risk for necrosis in vivo was estimated. The average weight of cement implanted was 5.35 g (2.65-8.08 g). The maximum temperature recorded averaged 64.7 degree C (48.2 degree-76.8 degree C). The area of bone at risk correlated with the amount of cement used. This study indicates that potentially dangerous amounts of heat may be generated during cementing of glenoid components.

Rotator cuff ultrasonography: diagnostic capabilities.

Dynamic shoulder ultrasonography is a noninvasive, accurate method used to assess the rotator cuff tendons. It can be incorporated into the in-office physical examination of patients at risk for rotator cuff problems. The low cost, convenience, and lack of risk make dynamic ultrasonography an excellent imaging tool for evaluating the biceps, subscapularis, infraspinatus, teres minor, and supraspinatus tendons. In-office ultrasound also provides an opportunity for patient education and explanation of management options.

The effect of total shoulder arthroplasty on self-assessed health status is comparable to that of total hip arthroplasty and coronary artery bypass grafting.

The purpose of this study was to assess the impact of total shoulder arthroplasty on the self-assessed health status of a large series of patients with glenohumeral osteoarthritis. In 91 patients we were able to compare the 8 quantitative domains of Short Form-36 (SF-36) before surgery and at 30 to 60 months after surgery. These preoperative and postoperative scores were compared with data from an age- and gender-matched control population. These results were also compared with those reported for patients who underwent other common, effective surgical procedures. Preoperative SF-36 values were significantly lower than population controls for 6 of 8 SF-36 domains (physical function, social function, physical role function, emotional role function, vitality, and comfort). Patients improved significantly in 4 of 8 SF-36 domains at 30 to 60 months after total shoulder arthroplasty: physical role function (P <.01), comfort (P <.01), social function (P <.01), and mental health (P <.05). Although the improvements were significant and similar to the postoperative scores reported for total hip arthroplasty and coronary bypass procedures, the scores did not reach those of the general population.

Characterizing the functional improvement after total shoulder arthroplasty for osteoarthritis.

BACKGROUND: Both shoulder surgeons and patients who are considering total shoulder arthroplasty are interested in the anticipated improvement in shoulder comfort and function after the procedure. The purpose of the present study was to characterize shoulder-specific functional gains in relation to preoperative shoulder function and to present this information in a way that can be easily communicated to patients who are considering this surgery. METHODS: We analyzed the preoperative and follow-up shoulder function in patients managed with total shoulder arthroplasty for the treatment of primary glenohumeral osteoarthritis. Functional self-assessments were available for 102 (80%) of 128 shoulders after thirty to sixty months of follow-up. Outcome was assessed with respect to the change in the number of shoulder functions that were performable, the change in shoulder function as a percentage of the preoperative functional deficit, and the change in the ability to perform specific shoulder functions. RESULTS: The average number of shoulder functions that were performable improved from four of twelve preoperatively to nine of twelve postoperatively (p < 0.01). Function improved in ninety-six shoulders (94%). The number of functions that were performable at the time of follow-up was positively associated with preoperative shoulder function (p < 0.05): the better the preoperative function, the better the follow-up function. The improvement in function was greatest for shoulders with less preoperative function (p < 0.01). On the average, patients regained approximately two-thirds of the functions that had been absent preoperatively. Significant improvement was noted in eleven of the twelve shoulder functions that were examined (p < 0.01). The chance of regaining a function that had been absent before surgery was 73%, whereas the chance of losing a function that had been present before surgery was 6%. Older men tended to have greater functional improvement than younger men. CONCLUSION: Total shoulder arthroplasty for the treatment of primary glenohumeral osteoarthritis significantly improves shoulder function. Postoperative function is related to preoperative function. The improvement that was observed in this clinical series can be conveyed to patients most simply by stating that, after surgery, shoulders typically regained approximately two-thirds of the functions that had been absent preoperatively.

Asynchronous web-based patient-centered home telemedicine system.

A web-based system for asynchronous multimedia messaging between shoulder replacement surgery patients at home and their surgeons was developed and tested. A web browser plug-in simplifies the process of capturing video and transferring it to a web site for novice computer users. The design of the video capture plug-in can be reused to acquire and securely transfer any type of data over the web. For example, readings from home biosensor instruments (e.g., glucometers and spirometers) that can be connected to a personal computer can be transferred to a home telemedicine web site. Both patients and doctors can access this web site to monitor health status longitudinally. Six patients, whose familiarity with computers ranged from no experience to expert users, used the system. All of the subjects were able to use the system to check treatment reminders and to send at least one message with video to their surgeons. The surgeons monitored the system regularly and always responded to messages within 24 h during the six-month trial period.