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Mark A Frankle - One of the best experts on this subject based on the ideXlab platform.
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DJO Surgical Reverse Shoulder Prosthesis (RSP
Reverse Shoulder Arthroplasty, 2015Co-Authors: Philip J. Mulieri, Michael M. Hussey, Mark A FrankleAbstract:Due to shortcomings of the reverse Shoulder prosthetics of the time, the DJO Reverse™ Shoulder Prosthesis (RSP) was designed to create a more anatomic alignment of the Shoulder and reduce the complications associated with the Grammont design. The main features of the Prosthesis are its lateral center of rotation and its central lag screw, providing a more anatomic center of rotation and a more compressive force, respectively. The humeral component offers both cemented and press-fit options that provide a better mechanical environment for the rotator cuff to assist with Shoulder motion. Outcomes for the RSP show consistent postoperative improvement as well as low complication rates in the modern design. The use of the RSP with proper surgical technique can result in predictably good outcomes.
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revision arthroplasty with use of a reverse Shoulder Prosthesis allograft composite
Journal of Bone and Joint Surgery American Volume, 2009Co-Authors: Ariel Chacon, Nazeem A Virani, Robert Shannon, Jonathan C Levy, Derek Pupello, Mark A FrankleAbstract:Background: Patients with disabling pain and loss of Shoulder function with associated proximal humeral bone loss following Shoulder arthroplasty have limited reliable treatment options. Our objective was to report the results, obtained as part of a prospective outcomes study, of the use of a reverse Shoulder Prosthesis-allograft composite in these patients. Methods: Between 2002 and 2005, 353 patients treated with a reverse Shoulder Prosthesis were enrolled in a prospective cohort study. Twenty-five patients received, in addition, a proximal humeral allograft for the management of severe proximal humeral bone loss, and they comprise the study group. The average bone loss measured 53.6 mm (range, 34.5 to 150.3 mm). Patients were followed clinically with use of the American Shoulder and Elbow Surgeons (ASES) score, the Simple Shoulder Test (SST), and a scale with which the patients rated their satisfaction, and they were followed radiographically to detect mechanical failure, loosening, notching, and graft healing. All patients were followed for a minimum of two years (average, 30.2 months). Results: The total average ASES score improved from 31.7 points preoperatively to 69.4 points at the time of follow-up (p < 0.0001), and the average SST score improved from 1.4 to 4.5 points (p < 0.0001). Nineteen patients (76%) reported a subjective good or excellent result, five reported a satisfactory result, and one reported that the result was unsatisfactory. The range of motion improved in forward flexion (from 32.7° to 82.4°; p < 0.0001), abduction (from 40.4° to 81.4°; p < 0.0001), and internal rotation. Radiographic evaluation at the time of final follow-up showed incorporation of the allograft in the metaphyseal region in 84% (twenty-one) of the twenty-five patients and incorporation of the allograft in the diaphyseal region in 76% (nineteen) of the patients. Four patients had complications. Conclusions: Use of a reverse Shoulder Prosthesis-proximal humeral allograft composite for the treatment of Shoulder dysfunction following arthroplasty associated with substantial proximal humeral bone loss has shown promising early results. The allograft may restore proximal humeral bone stock, thereby helping to maintain the height of the Prosthesis bone construct and thus deltoid tension. Additional, long-term studies are needed to evaluate the longevity of this construct. Level of Evidence: Therapeutic Level IV. See Instructions to Authors for a complete description of levels of evidence.
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biomechanical comparison of component position and hardware failure in the reverse Shoulder Prosthesis
Journal of Shoulder and Elbow Surgery, 2007Co-Authors: Mark A Frankle, Sergio Gutierrez, Michael R Greiwe, Steven SiegalAbstract:There has been renewed interest in reverse Shoulder arthroplasty for the treatment of glenohumeral arthritis with concomitant rotator cuff deficiency. Failure of the Prosthesis at the glenoid attachment site remains a concern. The purpose of this study was to examine glenoid component stability with regard to the angle of implantation. This investigation entailed a biomechanical analysis to evaluate forces and micromotion in glenoid components attached to 12 polyurethane blocks at −15°, 0°, and +15° of superior and inferior tilt. The 15° inferior tilt had the most uniform compressive forces and the least amount of tensile forces and micromotion when compared with the 0° and 15° superiorly tilted baseplate. Our results suggest that implantation with an inferior tilt will reduce the incidence of mechanical failure of the glenoid component in a reverse Shoulder Prosthesis.
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the use of the reverse Shoulder Prosthesis for the treatment of failed hemiarthroplasty for proximal humeral fracture
Journal of Bone and Joint Surgery American Volume, 2007Co-Authors: Jonathan C Levy, Mark A Frankle, Mark A Mighell, Derek PupelloAbstract:Background: Humeral hemiarthroplasty is an established treatment for patients with selected fractures of the proximal part of the humerus. However, a subset of patients have development of glenoid arthritis and rotator cuff deficiency due to tuberosity failure. To date, there has been no reliable salvage procedure for this problem. Methods: Over a period of five years, twenty-nine patients (twenty-five women and four men) with a mean age of sixty-nine years (range, forty-two to eighty years) were managed with removal of a hemiarthroplasty Prosthesis and revision with a Reverse Shoulder Prosthesis alone or in combination with a proximal humeral allograft. Patients were followed clinically and radiographically for an average of thirty-five months. All patients were evaluated with use of the American Shoulder and Elbow Surgeons score; the Simple Shoulder Test; range-of-motion measurements, including abduction, forward flexion, and external rotation; and a rating scale for overall satisfaction with the outcome of the surgery. Patients were assessed preoperatively and at all follow-up points beginning at three months postoperatively. Results: The average total American Shoulder and Elbow Surgeons score improved from 22.3 preoperatively to 52.1 at the time of the last follow-up (p < 0.001). The average American Shoulder and Elbow Surgeons pain score improved from 12.2 to 34.4 (p < 0.001), and the average American Shoulder and Elbow Surgeons function score improved from 10.1 to 17.7 (p = 0.058). The average Simple Shoulder Test score improved from 0.9 to 2.6 (p = 0.004). Forward flexion improved from 38.1° to 72.7° (p < 0.001), and abduction improved from 34.1° to 70.4° (p < 0.001). The overall complication rate was 28% (eight of twenty-nine). At the time of the latest follow-up, sixteen patients rated the outcome as good or excellent, seven rated it as satisfactory, and six were dissatisfied. Four of the six patients who were dissatisfied had been managed with a Reverse Shoulder Prosthesis alone. Conclusions: The Reverse Shoulder Prosthesis offers a salvage-type solution to the problem of failed hemiarthroplasty due to glenoid arthritis and rotator cuff deficiency following tuberosity failure. The early results reported here are promising. In cases of severe proximal humeral bone deficiency, augmentation of the Reverse Shoulder Prosthesis with a proximal humeral allograft may improve patient satisfaction. Level of Evidence: Therapeutic Level IV. See Instructions to Authors for a complete description of levels of evidence.
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use of the reverse Shoulder Prosthesis for the treatment of failed hemiarthroplasty in patients with glenohumeral arthritis and rotator cuff deficiency
Journal of Bone and Joint Surgery-british Volume, 2007Co-Authors: Jonathan C Levy, Nazeem A Virani, Derek Pupello, Mark A FrankleAbstract:We report the use of the reverse Shoulder Prosthesis in the revision of a failed Shoulder hemiarthroplasty in 19 Shoulders in 18 patients (7 men, 11 women) with severe pain and loss of function. The primary procedure had been undertaken for glenohumeral arthritis associated with severe rotator cuff deficiency. Statistically significant improvements were seen in pain and functional outcome. After a mean follow-up of 44 months (24 to 89), mean forward flexion improved by 26.4° and mean abduction improved by 35°. There were six Prosthesis-related complications in six Shoulders (32%), five of which had severe bone loss of the glenoid, proximal humerus or both. Three Shoulders (16%) had non-Prosthesis related complications. The use of the reverse Shoulder Prosthesis provides improvement in pain and function for patients with failure of a hemiarthroplasty for glenohumeral arthritis and rotator cuff deficiency. However, high rates of complications were associated with glenoid and proximal humeral bone loss.
Géza Pap - One of the best experts on this subject based on the ideXlab platform.
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Stemless Shoulder Prosthesis versus conventional anatomic Shoulder Prosthesis in patients with osteoarthritis
Journal of Orthopaedics and Traumatology, 2013Co-Authors: Alexander Berth, Géza PapAbstract:Background The stemless Shoulder Prosthesis is a new concept in Shoulder arthroplasty. To date, only a few studies have investigated the results of this Prosthesis. The aim of this study was to investigate the clinical and radiological midterm results of this implant in comparison with a standard anatomic stemmed Shoulder Prosthesis. Materials and methods The Constant score, the DASH score, the active range of motion (abduction, anteversion, external rotation), and the radiological results were examined in 82 patients with primary osteoarthritis of the Shoulder treated with either the Total Evolutive Shoulder System^® (Biomed, France) stemless Shoulder Prosthesis or the Affinis^® (Mathys, Switzerland) stemmed Shoulder Prosthesis to detect possible differences in the functional outcome and to evaluate radiological properties of the implants. Patients were examined before and 32 ± 4 months after surgery. Results There was no significant difference in the Constant scores of the groups treated with the stemless Shoulder Prosthesis (65.0 ± 11.0 points) and the stemmed Shoulder Prosthesis (73.2 ± 11.3 points; P = 0.162). The estimated blood loss ( P = 0.026) and the mean operative time ( P = 0.002) were significantly lower in the group with the stemless Shoulder Prosthesis. Conclusions The use of the stemless Shoulder Prosthesis yielded good results which, in a mid-term follow-up, were comparable with those provided by a standard anatomic Shoulder Prosthesis. Further investigations are needed regarding the long-term performance of this Prosthesis.
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Stemless Shoulder Prosthesis versus conventional anatomic Shoulder Prosthesis in patients with osteoarthritis
Journal of Orthopaedics and Traumatology, 2012Co-Authors: Alexander Berth, Géza PapAbstract:Background The stemless Shoulder Prosthesis is a new concept in Shoulder arthroplasty. To date, only a few studies have investigated the results of this Prosthesis. The aim of this study was to investigate the clinical and radiological midterm results of this implant in comparison with a standard anatomic stemmed Shoulder Prosthesis.
Alexander Berth - One of the best experts on this subject based on the ideXlab platform.
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SPECT/CT demonstrates the osseointegrative response of a stemless Shoulder Prosthesis
Journal of Shoulder and Elbow Surgery, 2015Co-Authors: Alexander Berth, Vincent März, Heiko Wissel, Friedemann Awiszus, Holger Amthauer, Christoph H. LohmannAbstract:Background This study evaluates bone remodeling processes in the proximal humerus induced by the implantation of a stemless Shoulder Prosthesis with regard to time of response and type and extent of bone turnover. Methods Twenty-eight patients with primary osteoarthritis of the Shoulder undergoing a stemless Shoulder arthroplasty were prospectively evaluated. The local metabolic bone activity in 5 regions of interest (ROIs 1-5) around the implant and in 1 reference region (ROI ref.) in the humeral diaphysis was analyzed after the application of technetium Tc 99m DPD using single-photon emission computed tomography integrated with multidetector computed tomography (SPECT/CT). The study cohort was divided into 4 groups according to the timing of the most recent follow-up appointment to evaluate the primary osseointegrative response after surgery. The bone uptake values were expressed in target (ROIs 1-5) to nontarget (ROI ref.) ratios. Results No difference within the 4 subgroups with respect to the time of local metabolic bone activity in the ROIs was found at 90 days after surgery. The highest initial metabolic activity and most temporal modifications were found in ROI 1, which was localized in the superior segment of the stem. Conclusions SPECT/CT data suggest that the primary osseointegration of a stemless Shoulder Prosthesis is almost completed 3 months after implantation. Variations in metabolic activity pattern in the ROIs during follow-up may be caused by different loading conditions of the bone.
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Stemless Shoulder Prosthesis versus conventional anatomic Shoulder Prosthesis in patients with osteoarthritis
Journal of Orthopaedics and Traumatology, 2013Co-Authors: Alexander Berth, Géza PapAbstract:Background The stemless Shoulder Prosthesis is a new concept in Shoulder arthroplasty. To date, only a few studies have investigated the results of this Prosthesis. The aim of this study was to investigate the clinical and radiological midterm results of this implant in comparison with a standard anatomic stemmed Shoulder Prosthesis. Materials and methods The Constant score, the DASH score, the active range of motion (abduction, anteversion, external rotation), and the radiological results were examined in 82 patients with primary osteoarthritis of the Shoulder treated with either the Total Evolutive Shoulder System^® (Biomed, France) stemless Shoulder Prosthesis or the Affinis^® (Mathys, Switzerland) stemmed Shoulder Prosthesis to detect possible differences in the functional outcome and to evaluate radiological properties of the implants. Patients were examined before and 32 ± 4 months after surgery. Results There was no significant difference in the Constant scores of the groups treated with the stemless Shoulder Prosthesis (65.0 ± 11.0 points) and the stemmed Shoulder Prosthesis (73.2 ± 11.3 points; P = 0.162). The estimated blood loss ( P = 0.026) and the mean operative time ( P = 0.002) were significantly lower in the group with the stemless Shoulder Prosthesis. Conclusions The use of the stemless Shoulder Prosthesis yielded good results which, in a mid-term follow-up, were comparable with those provided by a standard anatomic Shoulder Prosthesis. Further investigations are needed regarding the long-term performance of this Prosthesis.
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Stemless Shoulder Prosthesis versus conventional anatomic Shoulder Prosthesis in patients with osteoarthritis
Journal of Orthopaedics and Traumatology, 2012Co-Authors: Alexander Berth, Géza PapAbstract:Background The stemless Shoulder Prosthesis is a new concept in Shoulder arthroplasty. To date, only a few studies have investigated the results of this Prosthesis. The aim of this study was to investigate the clinical and radiological midterm results of this implant in comparison with a standard anatomic stemmed Shoulder Prosthesis.
William Tyndall - One of the best experts on this subject based on the ideXlab platform.
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Eclipse Stemless Shoulder Prosthesis versus Univers II Shoulder Prosthesis: A Multicenter, Prospective Randomized Controlled Trial.
Journal of Shoulder and Elbow Surgery, 2020Co-Authors: Anthony A. Romeo, Brandon J. Erickson, John G. Costouros, Nathan Long, Jeffrey Klassen, Arash Araghi, John W. Brown, Kevin Setter, Joshua Port, William TyndallAbstract:Abstract Background Total Shoulder arthroplasty is an accepted treatment for glenohumeral osteoarthritis. The Arthrex Eclipse Shoulder Prosthesis is a stemless, canal-sparing, humeral Prosthesis with bone ingrowth capacity on the trunnion as well as through the fenestrated hollow screw that provides both diaphyseal and metaphyseal load sharing and fixation. Methods 16 sites in the United States enrolled 327 patients (237 Eclipse, 90 Univers II) between 2013-2019. All patients had glenohumeral arthritis refractory to non-surgical care. Exclusion criteria were strict to avoid confounding factors such as severe patient co-morbidities, arthritis not consistent with osteoarthritis, and medical or prior surgical treatments that may affect outcomes. Patients were randomized to Eclipse or Univers II using block randomization. Results 149 Eclipse and 76 Univers II patients reached 2-year follow-up [139 (93.3%) Eclipse and 68 (89.5%) Univers II had complete data]. The success rate using the composite clinical success (CCS) score was 95% for Eclipse vs. 89.7% for Univers II group. No patient exhibited radiographic evidence of substantial humeral radiolucency, humeral migration, or subsidence at any point. There were 7 (3.2%) reoperations in the Eclipse and 3 (3.8%) in the Univers II group. Conclusion The Arthrex Eclipse Shoulder Prosthesis is a safe and effective humeral implant for patients with glenohumeral arthritis at two-year follow-up with no differences in outcomes when compared to the Univers II. Level of Evidence Level II; Randomized Controlled Trial; Treatment Study
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Eclipse stemless Shoulder Prosthesis vs. Univers II Shoulder Prosthesis: a multicenter, prospective randomized controlled trial.
Journal of shoulder and elbow surgery, 2020Co-Authors: Anthony A. Romeo, Brandon J. Erickson, John G. Costouros, Nathan Long, Jeffrey Klassen, Arash Araghi, Kevin Setter, Joshua Port, John Brown, William TyndallAbstract:Background Total Shoulder arthroplasty is an accepted treatment for glenohumeral osteoarthritis. The Arthrex Eclipse Shoulder Prosthesis is a stemless, canal-sparing humeral Prosthesis with bone ingrowth capacity on the trunnion, as well as through the fenestrated hollow screw, that provides both diaphyseal and metaphyseal load sharing and fixation. Methods Between 2013 and 2018, 16 sites in the United States enrolled 327 patients (Eclipse in 237 and Arthrex Univers II in 90). All patients had glenohumeral arthritis refractory to nonsurgical care. Strict exclusion criteria were applied to avoid confounding factors such as severe patient comorbidities, arthritis not consistent with osteoarthritis, and medical or prior surgical treatments that may have affected outcomes. Patients were randomized to the Eclipse or Univers II group via block randomization. Results In total, 149 Eclipse and 76 Univers II patients reached 2-year follow-up (139 Eclipse patients [93.3%] and 68 Univers II patients [89.5%] had complete data). The success rate using the Composite Clinical Success score was 95% in the Eclipse group vs. 89.7% in the Univers II group. No patient exhibited radiographic evidence of substantial humeral radiolucency, humeral migration, or subsidence at any point. Reoperations were performed in 7 patients (3.2%) in the Eclipse group and 3 (3.8%) in the Univers II group. Conclusion The Arthrex Eclipse Shoulder Prosthesis is a safe and effective humeral implant for patients with glenohumeral arthritis at 2-year follow-up, with no differences in outcomes compared with the Univers II Shoulder Prosthesis.
Matthew Vasey - One of the best experts on this subject based on the ideXlab platform.
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the reverse Shoulder Prosthesis for glenohumeral arthritis associated with severe rotator cuff deficiency a minimum two year follow up study of sixty patients surgical technique
Journal of Bone and Joint Surgery American Volume, 2006Co-Authors: Mark A Frankle, Steven Siegal, Jonathan C Levy, Derek Pupello, Mark A Mighell, Arif Saleem, Matthew VaseyAbstract:BACKGROUND: Patients who have pain and dysfunction from glenohumeral arthritis associated with severe rotator cuff deficiency have few treatment options. The goal of this study was to retrospectively evaluate the short-term results of arthroplasty with use of the Reverse Shoulder Prosthesis in the management of this problem. METHODS: We report the results for sixty patients (sixty Shoulders) with a rotator cuff deficiency and glenohumeral arthritis who were followed for a minimum of two years. Thirty-five patients had no previous Shoulder surgery, whereas twenty-three had had either an open or arthroscopic rotator cuff repair, one had had a subacromial decompression, and one had had a biceps tendon repair. All patients were assessed preoperatively and postoperatively with the American Shoulder and Elbow Surgeons scoring system for pain and function and with visual analog scales for pain and function. They were also asked to rate their satisfaction with the outcome. The Shoulder range of motion was measured preoperatively and postoperatively. RESULTS: The average age of the patients was seventy-one years. The average duration of follow-up was thirty-three months. All measures improved significantly (p < 0.0001). The mean total score on the American Shoulder and Elbow Surgeons system improved from 34.3 to 68.2; the mean function score, from 16.1 to 29.4; and the mean pain score, from 18.2 to 38.7. The score for function on the visual analog scale improved from 2.7 to 6.0, and the score for pain on the visual analog scale improved from 6.3 to 2.2. Forward flexion increased from 55.0° to 105.1°, and abduction increased from 41.4° to 101.8°. Forty-one of the sixty patients rated the outcome as good or excellent; sixteen were satisfied, and three were dissatisfied. There were a total of thirteen complications in ten patients (17%). Seven patients (12%) had eight failures, requiring revision surgery to another Reverse Shoulder Prosthesis in five patients (one Shoulder had two revisions) and revision to a hemiarthroplasty in two patients because of deep infection. CONCLUSIONS: The data from this study suggest that arthroplasty with the Reverse Shoulder Prosthesis may be a viable treatment for patients with glenohumeral arthritis and a massive rotator cuff tear. However, future studies will be necessary to determine the longevity of the implant and whether it will provide continued improvement in function.
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The reverse Shoulder Prosthesis for glenohumeral arthritis associated with severe rotator cuff deficiency. a minimum two-year follow-up study of sixty patients surgical technique.
The Journal of bone and joint surgery. American volume, 2006Co-Authors: Mark A Frankle, Steven Siegal, Jonathan C Levy, Derek Pupello, Mark A Mighell, Arif Saleem, Matthew VaseyAbstract:Patients who have pain and dysfunction from glenohumeral arthritis associated with severe rotator cuff deficiency have few treatment options. The goal of this study was to retrospectively evaluate the short-term results of arthroplasty with use of the Reverse Shoulder Prosthesis in the management of this problem. We report the results for sixty patients (sixty Shoulders) with a rotator cuff deficiency and glenohumeral arthritis who were followed for a minimum of two years. Thirty-five patients had no previous Shoulder surgery, whereas twenty-three had had either an open or arthroscopic rotator cuff repair, one had had a subacromial decompression, and one had had a biceps tendon repair. All patients were assessed preoperatively and postoperatively with the American Shoulder and Elbow Surgeons scoring system for pain and function and with visual analog scales for pain and function. They were also asked to rate their satisfaction with the outcome. The Shoulder range of motion was measured preoperatively and postoperatively. The average age of the patients was seventy-one years. The average duration of follow-up was thirty-three months. All measures improved significantly (p < 0.0001). The mean total score on the American Shoulder and Elbow Surgeons system improved from 34.3 to 68.2; the mean function score, from 16.1 to 29.4; and the mean pain score, from 18.2 to 38.7. The score for function on the visual analog scale improved from 2.7 to 6.0, and the score for pain on the visual analog scale improved from 6.3 to 2.2. Forward flexion increased from 55.0 degrees to 105.1 degrees , and abduction increased from 41.4 degrees to 101.8 degrees . Forty-one of the sixty patients rated the outcome as good or excellent; sixteen were satisfied, and three were dissatisfied. There were a total of thirteen complications in ten patients (17%). Seven patients (12%) had eight failures, requiring revision surgery to another Reverse Shoulder Prosthesis in five patients (one Shoulder had two revisions) and revision to a hemiarthroplasty in two patients because of deep infection. The data from this study suggest that arthroplasty with the Reverse Shoulder Prosthesis may be a viable treatment for patients with glenohumeral arthritis and a massive rotator cuff tear. However, future studies will be necessary to determine the longevity of the implant and whether it will provide continued improvement in function.
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the reverse Shoulder Prosthesis for glenohumeral arthritis associated with severe rotator cuff deficiency a minimum two year follow up study of sixty patients
Journal of Bone and Joint Surgery American Volume, 2005Co-Authors: Mark A Frankle, Steven Siegal, Derek Pupello, Mark A Mighell, Arif Saleem, Matthew VaseyAbstract:Patients who have pain and dysfunction from glenohumeral arthritis associated with severe rotator cuff deficiency have few treatment options. The goal of this study was to retrospectively evaluate the short-term results of arthroplasty with use of the Reverse Shoulder Prosthesis in the management of this problem. We report the results for sixty patients (sixty Shoulders) with a rotator cuff deficiency and glenohumeral arthritis who were followed for a minimum of two years. Thirty-five patients had no previous Shoulder surgery, whereas twenty-three had had either an open or arthroscopic rotator cuff repair, one had had a subacromial decompression, and one had had a biceps tendon repair. All patients were assessed preoperatively and postoperatively with the American Shoulder and Elbow Surgeons scoring system for pain and function and with visual analog scales for pain and function. They were also asked to rate their satisfaction with the outcome. The Shoulder range of motion was measured preoperatively and postoperatively. The average age of the patients was seventy-one years. The average duration of follow-up was thirty-three months. All measures improved significantly (p < 0.0001). The mean total score on the American Shoulder and Elbow Surgeons system improved from 34.3 to 68.2; the mean function score, from 16.1 to 29.4; and the mean pain score, from 18.2 to 38.7. The score for function on the visual analog scale improved from 2.7 to 6.0, and the score for pain on the visual analog scale improved from 6.3 to 2.2. Forward flexion increased from 55.0° to 105.1°, and abduction increased from 41.4° to 101.8°. Forty-one of the sixty patients rated the outcome as good or excellent; sixteen were satisfied, and three were dissatisfied. There were a total of thirteen complications in ten patients (17%). Seven patients (12%) had eight failures, requiring revision surgery to another Reverse Shoulder Prosthesis in five patients (one Shoulder had two revisions) and revision to a hemiarthroplasty in two patients because of deep infection. The data from this study suggest that arthroplasty with the Reverse Shoulder Prosthesis may be a viable treatment for patients with glenohumeral arthritis and a massive rotator cuff tear. However, future studies will be necessary to determine the longevity of the implant and whether it will provide continued improvement in function. Therapeutic Level IV. See Instructions to Authors for a complete description of levels of evidence.
