Bony increased-offset reverse shoulder arthroplasty vs. metal augments in reverse shoulder arthroplasty: a prospective, randomized clinical trial with 2-year follow-up.

BACKGROUND: Reverse shoulder arthroplasty (RSA) is rapidly being adopted as the standard procedure for a growing number of shoulder pathologies. Lateralization of the glenoid component is known to reduce the incidence of scapular notching and possibly improve postoperative range of motion. A number of methods are used for glenoid component lateralization, including bony increased-offset reverse shoulder arthroplasty (BIO-RSA) and porous metal-augmented baseplates. Presently, there exists little comparative literature on bone vs. metal lateralization. Therefore, the purpose of this study was to compare BIO-RSA to metal-augmented glenoid baseplates by assessing clinical outcomes and baseplate migration using model-based radiostereometric analysis. METHODS: A power analysis indicated 40 patients would be required for this radiostereometric study. Therefore, 41 shoulders were prospectively randomized to receive either glenoid bone grafting (BIO-RSA) or a porous metal-augmented wedge-shaped titanium baseplate for primary reverse shoulder arthroplasty. At the time of primary surgery, all patients also underwent implantation of 8 tantalum marker beads in the glenoid and coracoid. Following surgery, participants were imaged using a calibrated, stereo radiographic technique. Radiographs were acquired at 6 weeks (baseline), 3 months, 6 months, 1 year, and 2 years postoperatively. Migration of the prosthesis was compared between bone and metal lateralization groups at each time point using a mixed effects model with Bonferroni test for multiple comparisons. Outcome measures were acquired preoperatively and 2 years postoperatively. RESULTS: No significant differences were observed along any translation or rotation axis at any time point for either glenoid fixation group (P ≥ .175). Mean total glenoid component translation (± standard deviation) 2 years postoperatively was 0.4 ± 0.2 mm and 0.5 ± 0.3 mm for BIO-RSA and metal-augmented baseplates, respectively (P = .784). No significant differences were observed between groups in active range of motion; pain; American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form score; Simple Shoulder Test score; Disabilities of the Arm, Shoulder, and Hand score; Constant Shoulder score; or Subjective Shoulder Value (P ≥ .117), with the exception of increased active external rotation in the BIO-RSA cohort (P = .036). CONCLUSION: This randomized clinical trial assessed reverse shoulder arthroplasty glenoid component migration using model-based radiostereometric analysis. At 2-year follow-up, our results indicate both BIO-RSA and porous metal wedge augmented baseplates provide stable initial fixation, which is maintained at 2 years' follow-up, with no substantial differences in clinical outcomes.

Are short press-fit stems comparable to standard-length cemented stems in reverse shoulder arthroplasty? A prospective, randomized clinical trial.

BACKGROUND: The literature comparing humeral implants in reverse shoulder arthroplasty is sparse. With minimal supporting literature, there has been a trend away from standard-length cemented humeral implants to press-fit stems and, recently, to shorter-stem implants. It is known that early implant migration, within the first 2 years postoperatively, is predictive of later implant loosening and possible revision surgery. Therefore, the purpose of this study was to compare clinical outcomes and implant migration between cemented standard-length humeral stems and press-fit short stems using model-based radiostereometric analysis. METHODS: After a power analysis, 41 shoulders were prospectively randomized to receive either a cemented standard-length or press-fit short humeral stem for primary reverse shoulder arthroplasty between July 2017 and June 2019. Following surgery, participants were imaged with stereo radiographs acquired at 6 weeks (baseline), 3 months, 6 months, 1 year, and 2 years. Migration of the humeral stem at each time point was compared with baseline, with differences in migration between cohorts assessed using a mixed-effects model with the Bonferroni test for multiple comparisons. Patient-reported outcome measures (Subjective Shoulder Value; American Shoulder and Elbow Surgeons shoulder score; Simple Shoulder Test score; Disabilities of the Arm, Shoulder and Hand score; and Constant score) were also compared. RESULTS: At 6 months (P = .025), 1 year (P = .004), and 2 years (P = .001) postoperatively, press-fit short stems migrated significantly more than cemented stems along the superior-inferior translation axis; in addition, they showed greater total translation at 2 years (P = .003). Mean total translation (± standard deviation) at 2 years was 0.4 ± 0.2 mm and 1.0 ± 1.1 mm for the cemented and press-fit cohorts, respectively. Mean migration between the 1- and 2-year time points was minimal for both stem fixation groups along all axes (<0.1 mm and 0.6°). There was no difference in active range of motion, pain, or validated outcome measures between the cohorts at 2 years (P ≥ .170). CONCLUSION: This randomized clinical trial shows that press-fit short humeral stems subside substantially more than standard-length cemented stems but ultimately achieve stability from 1 year through 2 years. Conversely, no significant differences were observed in clinical outcomes between cohorts.

Monitoring daily shoulder activity before and after reverse total shoulder arthroplasty using inertial measurement units.

BACKGROUND: The purpose of this study was to use at-home, portable, continuous monitoring technologies to record arm motion and activity preoperatively and postoperatively after reverse total shoulder arthroplasty (RTSA). METHODS: Thirty-three patients indicated for RTSA were monitored preoperatively and 3 and 12 months postoperatively. Inertial measurement units were placed on the sternum and upper arm of the operative limb, recording humeral motion relative to the torso for the duration of a waking day. Elevation events per hour (EE/h) > 90°, time spent at >90°, and activity intensity were calculated and compared between time points. Patient-reported outcome measures were also collected at all time points. RESULTS: At 3 (P = .040) and 12 (P = .010) months after RTSA, patients demonstrated a significantly greater number of EE/h > 90° compared with preoperatively. There were no significant differences (P ≥ .242) in the amount of time spent at different elevation angles at any time point or in arm activity intensity. Overall, 95% of the day was spent at elevation angles < 60°, and 90% of the day was spent in a low- or moderate-intensity state. Pearson correlations demonstrated relationships between forward elevation and the number of EE/h (r = 0.395, P = .001) and the number of EE/h > 90° (r = 0.493, P < .001). CONCLUSION: After RTSA, patients significantly increase the frequency of arm elevation to higher angles. However, we found no differences in the amount of time spent at different elevation angles. Overall, after RTSA, >95% of the day was spent at elevation angles < 60° and <1% of the day was spent at >90° of elevation.

In vivo reverse total shoulder arthroplasty contact mechanics.

BACKGROUND: Several in vitro studies have investigated the biomechanics of reverse total shoulder arthroplasty (RTSA); however, few in vivo studies exist. The purpose of this study was to examine in vivo RTSA contact mechanics in clinically relevant arm positions. Our hypothesis was that contact would preferentially occur in the inferior region of the polyethylene liner. METHODS: Forty patients receiving a primary RTSA were recruited for a prospective cohort study. All patients received the same implant design with a nonretentive liner. Stereo radiographs were taken at maximal active range of motion. Model-based radiostereometric analysis was used to identify implant position. Contact area between the polyethylene and glenosphere was measured as the geometric intersection of the 2 components and compared with respect to polyethylene liner size, arm position, and relative position within the liner. RESULTS: There were no differences in the proportion of contact area in any arm position between polyethylene liner sizes, ranging from 30% ± 17% to 38% ± 23% for 36-mm liners and 32% ± 21% to 41% ± 25% for 42-mm liners. Contact was equally distributed between the superior and inferior halves of the liner at each arm position (P = .06-.79); however, greater contact area was observed in the outer radius of the liner when the arm was flexed (P = .002). CONCLUSION: This study highlights that contact mechanics are similar between 36- and 42-mm liners. Contact area is generally equally distributed throughout the liner across the range of motion and not preferentially in the inferior region as hypothesized.

In vivo volumetric and linear wear measurement of reverse shoulder arthroplasty at minimum 5-year follow-up.

BACKGROUND: Reverse shoulder arthroplasty is quickly becoming the most frequently performed glenohumeral joint replacement. The purpose of this study was to evaluate the volumetric and linear wear rates of ultrahigh-molecular-weight polyethylene humeral liners in vivo at a minimum 5-year follow-up. METHODS: Radiostereometric analysis was used to image 15 patients at terminal range of motion in forward flexion, abduction, external rotation, and internal rotation and with the arm at the side. The relative position and orientation of the glenosphere and polyethylene were identified for each arm position. The apparent intersection of the glenosphere into the polyethylene was recorded as wear. Mean volumetric and linear wear rates were recorded, and Pearson correlation coefficients were applied to the 36-mm liners to assess the relationship between the wear rate and term of service. RESULTS: The mean reverse shoulder arthroplasty term of service at the time of imaging was 8 ± 1 years (range, 6-11 years). The mean volumetric and linear wear rates for the 36-mm liners (n = 13) were 42 ± 22 mm3/yr (r = 0.688, P = .009) and 0.11 ± 0.03 mm/yr (r = 0.767, P = .002), respectively. The mean volumetric and linear wear rates for the 42-mm liners (n = 2) were 114 ± 44 mm3/yr and 0.17 ± 0.01 mm/yr, respectively. No single arm position was able to capture all recorded wear individually. CONCLUSION: This study showed volumetric and linear wear rates of approximately 40 mm3/yr and 0.1 mm/yr, respectively, for the 36-mm polyethylene liners. The 42-mm liners showed higher wear rates, although a greater number of subjects is required for conclusive results. In vivo wear of reverse total shoulder arthroplasty is multidirectional and perceptible.

Validation of In Vivo Linear and Volumetric Wear Measurement for Reverse Total Shoulder Arthroplasty Using Model-Based Radiostereometric Analysis.

Presently, polyethylene wear measurement of reverse total shoulder arthroplasty (rTSA) is restricted to in vitro, in silico, and retrieval analysis, with no method for the quantification of in vivo wear of well-functioning implants. The purpose of this study was to validate the use of model-based radiostereometric analysis (MBRSA) as a measurement tool for in vivo rTSA wear using a phantom setup. Six additively manufactured polyethylene inserts were fabricated, one unworn control and five to represent known wear patterns, and individually fit within the rTSA components. Each insert was imaged using standard radiostereometric techniques and analyzed using MBRSA. From the position and orientation estimation provided by MBRSA, a micro-computed tomography model of the control insert was virtually placed within the metaphyseal tray. The apparent intersection of the glenosphere into the insert was recorded as wear. This method enables wear measurements with a linear precision of 0.21 mm and a bias of 0.36 ± 0.13 mm, and a volumetric precision of 49.3 mm3 , with a bias of 48.9 ± 24.3 mm3 . This technique allows for the in vivo measurement of polyethylene wear without the requirement of marker beads or baseline radiographs, expanding the potential for in vivo wear measurements to larger populations and retrospective analysis. © 2019 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 37:1620-1627, 2019.

Additively manufactured implant components for imaging validation studies.

Radiographic imaging is the current standard for evaluating postoperative joint replacements. Prior to application, such imaging methods need to be validated to determine the lower limits of performance under ideal conditions, using either a phantom or cadaver setup. Conventionally manufactured orthopedic implants for use in such studies are not always accessible and may be cost-prohibitive to purchase. We propose the use of additively manufactured implants as a cheaper, more accessible alternative for use in radiographic imaging validation studies. Bias and repeatability were compared between conventionally manufactured and additively manufactured reverse total shoulder implant sets under a standard model-based radiostereometric analysis phantom study environment. Measurements were compared using the humeral stem or glenosphere model relative to reference bone beads, and the humeral stem relative to the glenosphere model to measure implant relative displacement. Compared to the conventionally manufactured implants, the additively manufactured implants had less bias along the internal-external rotation axis (p < 0.001), but greater bias along the abduction-adduction and flexion-extension rotation axes (p = 0.005, 0.011). Additively manufactured implants had greater repeatability along the internal-external rotation axis (p < 0.001), but worse repeatability along the medial-lateral translation axis (p = 0.001) and the abduction-adduction rotation axis (p < 0.001). Differences were on the orders of 0.01 mm and 0.5°. For the purpose of validating two-dimensional-three-dimensional radiographic imaging techniques of orthopedic implants, additively manufactured implants can be used in place of conventionally manufactured implants, assuming they are fabricated to the manufacturer's specifications. Observed differences were within the errors of the measurement technique and not clinically meaningful.

Validation of radiostereometric analysis in six degrees of freedom for use with reverse total shoulder arthroplasty.

A phantom study was conducted to determine bias in motion and bias at zero motion of radiostereometric analysis (RSA) for evaluating implant relative displacement in reverse total shoulder arthroplasty (RTSA). A Sawbones shoulder phantom was fitted with a RTSA implant set and 13 tantalum markers. The model was fixed to a manual micrometer, providing controlled movements though fifteen known increments in translation and twelve increments in rotation (0.02-5.00 mm and 0.1-6.0°), along each translation and rotation axis. Movement between the glenoid and humerus was assessed using beads vs. beads (B/B), model vs. beads (M/B), and model vs. model (M/M) measurement methods in a model-based RSA environment. Bias in motion and bias at zero motion were defined as the difference between measured and accepted reference values, and the difference between double examinations with a theoretical displacement of zero, respectively. Bias in motion ranged from 0.054 ±â€¯0.010 to 0.129 ±â€¯0.014 mm and 0.076 ±â€¯0.025 to 0.126 ±â€¯0.025° (B/B), 0.023 ±â€¯0.009 to 0.126 ±â€¯0.016 mm and 0.111 ±â€¯0.033 to 0.794 ±â€¯0.251° (M/B), and 0.029 ±â€¯0.010 to 0.135 ±â€¯0.030 mm and 0.243 ±â€¯0.088 to 0.384 ±â€¯0.153° (M/M). Bias at zero motion ranged from 0.120 to 0.156 mm and 0.075 to 0.206° (B/B), 0.074 to 0.149 mm and 0.067 to 1.953° (M/B), and 0.069 to 0.259 mm and 0.284 to 1.273° (M/M). This is the first RSA for RTSA study, with results comparable to those validating the use of RSA for hip and knee arthroplasties (accepted as 0.05-0.50 mm and 0.15-1.15°), justifying the potential use of RSA as a tool for measuring implant displacement in the shoulder.