Patient-determined Outcomes Research Articles

Reverse Total Shoulder Arthroplasty Using Lateralized Glenoid Baseplates Has Superior Patient-determined Outcome Scores at Short-term Follow-up.

There are a variety of baseplate options when performing reverse total shoulder arthroplasty (RTSA). Currently, there is no consensus on the optimal glenoid baseplate. The hypothesis of this study was that the use of lateralized baseplates would improve patient-determined outcomes and postoperative range of motion after RTSA compared with standard baseplates without increasing the risk of complications. Patients undergoing RTSA were stratified into a standard baseplate group (SBG) and a lateralized baseplate group (LBG). The LBG included 3 mm lateralization, 6 mm lateralization, and full-wedge augmentation (8 mm lateralization). The Western Ontario Osteoarthritis Score, American Shoulder and Elbow Surgeons score, Single Assessment Numeric Evaluation (SANE), and Simple Shoulder Test (SST) were recorded at baseline, 1 year, and 2 years. Range of motion was recorded at baseline and 1 year. Differences in complications between groups were recorded. The LBG included 187 patients, and the SBG included 51 patients. No difference was observed in any patient-determined outcome score at 1-year follow-up. At 2 years, there were greater Western Ontario Osteoarthritis Score (84 ± 16 versus 74 ± 19; P = 0.01), American Shoulder and Elbow Surgeons score (81 ± 15 versus 70 ± 20; P = 0.001), SST (8.0 ± 2.4 versus 6.6 ± 2.6; P = 0.007), and SANE (82 ± 17 versus 68 ± 25; P = 0.0005). The improvement in SST (5.0 ± 2.7 versus 3.3 ± 3.6; P = 0.02) and SANE (54 ± 26 versus 37 ± 30; P = 0.004) at 2 years compared with baseline was greater in the LBG compared with the SBG. No difference was observed in any range-of-motion metric between groups. Total complications were similar between groups (P = 0.91). Scapular notching was more prevalent in the SBG (7.8% versus 1.6%; P = 0.01). The LBG had better patient-determined outcome scores compared with the SBG at 2-year follow-up with a similar rate of overall complications but a lower rate of scapular notching. Range of motion was not improved by the use of a lateralized baseplate compared with a standard baseplate.

Lateralization of the humerus in reverse total shoulder arthroplasty: can preoperative planning software predict postoperative lateralization and does lateralization influence outcomes?

IntroductionReverse total shoulder arthroplasty (RTSA) can result in varying amounts of humeral medialization or lateralization. The amount of medial or lateral change-in-arm-position can be predicted using 3D CT planning software. It is not clear if the preoperatively-predicted change-in-arm-position correlates with the actual, radiographically-measured change-in-arm-position or if predicted or actual change-in-arm-position correlates with patient-reported outcomes or complications. MethodsPatients undergoing RTSA underwent preoperative 3D CT planning to predict the postoperative medial-to-lateral change-in-arm-position (PCAP). Preoperative and postoperative radiographs were used to calculate the actual medial-to-lateral change-in-arm-position using the measurement of the lateral edge of the greater tuberosity to the lateral edge of the acromion (RCAP-LHO). The Western Ontario Osteoarthritis Score (WOOS), American Shoulder and Elbow Surgeons score (ASES) and Single Assessment Numeric Evaluation (SANE) were recorded at baseline, 1-year, and 2-years. Rates of complications were recorded. ResultsTwo-hundred-and-fifty patients were eligible for this study including 189 patients reaching the one-year clinical follow-up point and 144 patients reaching the two-year clinical follow-up point. One-year and two-year follow-up rates were 89 percent and 91 percent, respectively. The mean PCAP was 3+5 mm and RCAP-LHO was 1+8 mm. There was moderate correlation between PCAP and RCAP-LHO. There was weak correlation between increased PCAP lateralization and higher WOOS and ASES at two years and improvement from baseline to 2 years in WOOS. There was very weak correlation between increased PCAP lateralization and improvement compared to baseline in 1 year SANE and improvement compared to baseline in 2 year SANE. There was weak correlation between lateralized RCAP-LHO and 2 year postoperative SANE. There was superior 2-year WOOS, ASES, and SANE, and improvement in SANE at 1-year compared to baseline in patients with a lateralized PCAP compared to a medialized or neutral PCAP. There was superior 2-year WOOS, improvement in WOOS from baseline to 2-year follow-up, and SANE at 2-years in patients with a lateralized RCAP-LHO compared to a medialized or neutral RCAP-LHO. Overall complication rates were similar between groups although the dislocation rate in shoulders with a lateralized change-in-arm-position was significantly less compared to shoulders with a medial or neutral change-in-arm-position. ConclusionsPCAP correlated with actual RCAP-LHO. Correlations exist with increased humeral lateralization and improved patient-determined outcomes. Patient-determined outcomes were the same or better in patients with a lateralized change-in-arm-position compared to those that were medialized or remained neutral. A lateralized change-in-arm-position did not result in increased overall complications and was protective against postoperative instability.

Patients that have intraoperative deviations in their preoperative plan have inferior clinical and radiographic outcomes after anatomic total shoulder arthroplasty.

Three-dimensional, computed tomography, preoperative planning has become adopted among shoulder arthroplasty surgeons. Prior studies have not examined outcomes in patients in which the surgeon implanted prostheses that deviated from the preoperative plan compared to patients in which the surgeon followed the preoperative plan. The hypothesis of this study was that clinical and radiographic outcomes would be equivalent between patients undergoing anatomic total shoulder arthroplasty that had a deviation in the components predicted in the preoperative plan compared to patients that did not have a change in the components predicted in the preoperative plan. A retrospective review of patients that had preoperative planning for anatomic total shoulder arthroplasty from March 2017 thru October 2022 was performed. Patients were stratified into two groups: patients in which the surgeon utilized components that deviated from those anticipated by the preoperative plan (changed group), and patients in which the surgeon utilized all of the components anticipated by the preoperative plan (planned group). Patient-determined outcomes including the Western Ontario Osteoarthritis Index (WOOS), American Shoulder and Elbow Surgeons Score (ASES), Single Assessment Numeric Evaluation (SANE), Simple Shoulder Test (SST), and Shoulder Activity Level (SAL) were recorded preoperatively, at one-year, and at two-years. Preoperative and one-year postoperative range-of-motion was recorded. Radiographic parameters to assess restoration of proximal humeral anatomy included humeral head height, humeral neck angle, humeral centering on the glenoid, and postoperative restoration of the anatomic center of rotation. One-hundred-and-fifty-nine patients had intraoperative changes to their preoperative plan and 136 patients underwent arthroplasty without changes to their preoperative plan. The planned group had higher scores compared to the group that had a deviation in the preoperative plan for every patient-determined outcome metric at every postoperative timepoint with statistically significant improvements found in the SST and SANE at one-year and SST and ASES at two-year follow-up. No differences were found in range of motion metrics between groups. Patients that did not have a deviation in their preoperative plan had more optimal restoration of their postoperative radiographic center of rotation compared to patients that did have a deviation in their preoperative plan. Patients that have intraoperative changes to their preoperative plan have 1) inferior postoperative patient determined outcome scores at one and two years after surgery and 2) a larger deviation in the postoperative radiographic restoration of the humeral center of rotation compared to patients that did not have intraoperative changes from the initial plan.

Is stemless total shoulder arthroplasty indicated in elderly patients?

Stemmed anatomic total shoulder arthroplasty has represented the gold standard for the treatment of glenohumeral osteoarthritis with an intact rotator cuff for decades. To the author's knowledge, no study has specifically examined the outcomes of stemless, modular total shoulder arthroplasty in elderly patients. The hypothesis of this study was that stemless anatomic total shoulder arthroplasty in elderly patients (age ≥70 years) would have equivalent clinical and radiographic outcomes compared with a younger population (age <70 years). A prospectively collected database of patients undergoing primary, modular, stemless anatomic total shoulder arthroplasty for osteoarthritis was retrospectively reviewed. Patient-determined outcomes including the Western Ontario Osteoarthritis Index (WOOS) score, American Shoulder and Elbow Surgeons (ASES) score, Single Assessment Numeric Evaluation (SANE) score, Simple Shoulder Test score, and Shoulder Activity Level score were recorded preoperatively and postoperatively at 1 year and 2 years. Preoperative and 1-year postoperative range of motion was recorded. Postoperative radiographs were examined to assess for radiographic evidence of complications. Stemless arthroplasty was planned in 116 patients. Seven patients underwent conversion intraoperatively to a stemmed prosthesis. There was no difference between patients aged <70 yr and those aged ≥70 years who required intraoperative deviation from the preoperative plan to a stemmed prosthesis (5.8% vs 6.4%, P=.90). At the time of stemless arthroplasty, 64 patients were aged <70 yr and 44 patients were aged ≥70 years. Between the 2 groups, there were no clinically or statistically significant differences in WOOS, ASES, and SANE scores at baseline, 1-year follow-up, or 2-year follow-up. The changes in all scores from baseline to 2 years were similar between the group aged <70 yr and the group aged ≥70 years. There was no difference in the percentage of patients achieving the minimal clinically important difference or substantial clinical benefit in either group after shoulder arthroplasty at 2-year follow-up. There was no difference between the 2 groups in terms of final postoperative range of motion or change in range of motion for any metric examined. There was no evidence of radiographic complications in either group. Age ≥70 years does not appear to be a contraindication to stemless anatomic total shoulder arthroplasty. Postoperative improvements in patient-determined outcome scores, the percentage of patients achieving clinically important outcomes for the ASES, SANE, and WOOS scores, and postoperative range of motion were similar between patients aged <70 yr and those aged ≥70 years. There was no difference between the groups regarding the patients who required intraoperative deviation from the preoperatively planned stemless prosthesis to a stemmed prosthesis. Neither age group demonstrated a radiographically apparent complication.

Can the Single Assessment Numeric Evaluation be used as a stand-alone subjective outcome instrument in patients undergoing rotator cuff repair?

There is no consensus to which patient-determined shoulder outcome scores should be considered when analyzing patient outcomes. Use of multiple patient-determined outcomes may be redundant and cause increased responder burden. The Single Assessment Numeric (SANE) has not been widely accepted as a stand-alone shoulder-specific outcome measure. The hypothesis was that SANE will correlate with and be comparable in responsiveness to other subjective outcome measures that have been used in a stand-alone fashion in patients undergoing rotator cuff repair (American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form [ASES], Western Ontario Rotator Cuff Index [WORC], and the Simple Shoulder Test [SST]). In addition, the SANE will be more relevant to each patient compared to the ASES, further supporting its use as a stand-alone shoulder-specific outcomes measure. A retrospective review of a database of patients undergoing rotator cuff repair was reviewed where the SANE was recorded with the ASES, WORC, and/or SST. Correlations were determined using the Pearson coefficient. Subgroup analysis was performed to determine if correlations differed in (1) preoperative and (2) postoperative outcome determinations. Responsiveness was determined by calculating the standardized response mean (SRM) and the effect size (ES) of all scores. Relevance and precision of the SANE and ASES were examined using 150 consecutive patients to determine the number of questions in each score that were not answered. Correlation was excellent for the SANE and the ASES (n=1838, r=0.81, P<.0001), the WORC (n=1793, r=0.82, P<.0001), and the SST (n=1836, r=0.76, P<.0001). Correlation of preoperative scores was moderate and postoperative scores were excellent when comparing the SANE with all 3 scores. All scores were highly responsive, with the SRM of the SANE=2.1, ASES=2.2, WORC=2.4, and the SST=1.8. The ES of the SANE=2.4, ASES=2.7, WORC=3.0, and the SST=2.1. One hundred percent of the SANE scores were answered completely compared with 57% (P<.0001) of the ASES, with significant variability found in the answers to the "work" and "score" questions. In patients undergoing rotator cuff repair, the SANE highly correlated and has equivalent responsiveness with the WORC, ASES, and SST, which have been used as stand-alone shoulder-specific outcomes measures. The SANE may provide the same information as the WORC, ASES, and SST regarding outcome with significant reduction in responder burden. This study supports that the SANE can be used as a subjective, stand-alone instrument for patients undergoing rotator cuff repair.

Stemless and stemmed total shoulder arthroplasty: a comparison of short-term clinical and radiographic outcomes

BackgroundStemless total shoulder arthroplasty could provide benefits over stemmed arthroplasty which has represented the gold standard for decades. Proposed benefits of stemless arthroplasty include better reproduction of anatomy and reduction in stress shielding; however, this does not appear to be confirmed by any study. The hypothesis was there would be no clinical differences between the stemless and the short-stem prosthesis, but the stemless prosthesis would better reproduce coronal radiographic anatomy and have less radiographic evidence of stress shielding. Materials and MethodsA prospectively collected data of patients undergoing primary, anatomic total shoulder arthroplasty for osteoarthritis were retrospectively reviewed. Patient-determined outcomes including the Western Ontario Osteoarthritis Index, American Shoulder and Elbow Surgeons score, Single Assessment Numeric Evaluation, Simple Shoulder Test, and Shoulder Activity Level were recorded preoperatively, at 1 year, and at 2 years. Preoperative and 1-year postoperative range of motion was recorded. Radiographic parameters to assess restoration of proximal humeral anatomy included humeral head height, humeral neck angle, humeral centering on the glenoid, and postoperative restoration of the anatomic center of rotation. Final postoperative radiographs were assessed for evidence of stress shielding. ResultsForty-eight patients had a stemmed humeral prosthesis, and 109 patients had a stemless prosthesis. Patient-determined outcomes were available from 2 years postoperatively in 99.4%. Both groups had significant improvements in all patient-reported outcomes and range-of-motion metrics, but there were no differences between the stemless and stemmed groups in these outcomes. The prosthetic humeral head of the stemmed components was more likely to extend further superior to the humeral osseous margin than that of the stemless group (2.0 ± 2.4 vs. 0.8 ± 1.4 mm; P = .0004). The stemless group had a smaller postoperative deviation from the anatomic center of rotation than the stemmed group (2.5 ± 1.9 vs. 3.2 ± 2.1 mm; P = .04). The humeral neck angle was comparable between the stemmed group and the stemless group (133 ± 7° vs. 131 ± 8°; P = .06). There was similar mean deviation of humeral head centering on the glenoid prosthesis between the stemmed and stemless groups (1.9 ± 1.8 vs. 1.6 ± 1.7 mm; P = .20). There was evidence of stress shielding in 10 patients (21%) with a stemmed prosthesis and in no patients with a stemless prosthesis at 1-year follow-up (P < .0001). ConclusionsThere were no differences in patient-determined outcomes between the groups at 2-year follow-up. Restoration of proximal humeral anatomy was either better or equivalent with the stemless prosthesis compared to the stemmed one. Radiographic evidence of stress shielding was found in the stemmed prosthesis but not in the stemless prosthesis at 1-year follow-up.

Can the Single Assessment Numeric Evaluation (SANE) be used as a stand-alone outcome instrument in patients undergoing total shoulder arthroplasty?

There is no consensus as to which patient-determined shoulder outcome scores should be considered when analyzing patient outcomes for either clinical or research purposes. Use of multiple patient-determined outcomes may be redundant and cause increased responder burden. To date, the Single Assessment Numeric Evaluation (SANE) has not been widely accepted as a stand-alone shoulder-specific outcome measure. The hypothesis of this study was that the SANE would correlate with and be equal or superior in responsiveness to other outcome measures that have been used in a stand-alone fashion in patients undergoing total shoulder arthroplasty (American Shoulder and Elbow Surgeons [ASES], Western Ontario Osteoarthritis of the Shoulder [WOOS], and Simple Shoulder Test [SST] scores). In addition, it was hypothesized that the SANE would be more relevant to each patient than the ASES assessment, further supporting the use of the SANE as a stand-alone shoulder-specific outcome measure. A retrospective review of a database of patients undergoing total shoulder arthroplasty was performed, in which the SANE score was recorded simultaneously with the ASES, WOOS, and/or SST score. Correlations were determined using the Pearson coefficient. Subgroup analysis was performed to determine whether correlations differed in (1) preoperative outcome and (2) postoperative outcome determinations. Responsiveness was determined by calculating the standardized response mean and the effect size of all scores.The relevance of the SANE and ASES assessments was examined using the scores of 150 consecutive patients to determine the number of questions on each assessment that were not answered. Correlation was excellent for the SANE score and the ASES score (n=1447, r=0.82, P<.0001), WOOS score (n=1514, r=0.83, P<.0001), and SST score (n=1095, r=0.81, P<.0001). The correlation of preoperative scores was moderate and that of postoperative scores was strong-moderate when the SANE score was compared with all 3 other scores. All scores were highly responsive, with standardized response mean values of 2.2 for the SANE score, 2.3 for the ASES score, 1.4 for the WOOS score, and 1.6 for the SST score. The effect size of the SANE score was 2.9; ASES score, 2.9; WOOS score, 2.9; and SST score, 2.3. One hundred percent of the SANE questions were answered completely compared with 61% of the ASES questions (P<.0001). In patients undergoing total shoulder arthroplasty, the SANE score highly correlated with the WOOS, ASES, and SST scores, which have been used as stand-alone shoulder-specific outcome measures. The SANE score may provide the same information as the WOOS, ASES, and SST score regarding outcomes with a significant reduction in responder burden. It is logical that the SANE can be used as a stand-alone instrument for patients undergoing total shoulder arthroplasty.

Glenoid and scapulohumeral characteristics and their influence on preoperative range of motion and patient-determined outcomes

BackgroundIt is not clear if glenoid and scapulohumeral characteristics influence preoperative range of motion (ROM) and patient-determined outcomes. It is important to understand these interactions when planning and performing total shoulder arthroplasty in efforts of improving patient satisfaction and implant longevity. MethodsA retrospective review of patients that had three-dimensional computed tomography imaging for total shoulder arthroplasty was performed. Patients were separated into 2 groups determined by the presence (rotator cuff tear arthropathy [RCTA]) or absence (osteoarthritis [OA]) of an irreparable rotator cuff tear. Using the computed tomography measurements, shoulders were stratified by glenoid version (anteverted, normal, and retroverted), glenoid inclination (inferior, normal, and superior), and scapulohumeral subluxation (anterior, centered, and posterior) based on criteria determined from a review of the orthopedic literature. The Western Ontario Osteoarthritis Scale and the American Shoulder and Elbow Surgeons scores and ROM were determined preoperatively. ResultsIn OA patients (n = 154), version was associated with scapulohumeral subluxation (P < .0001). Retroverted glenoids had less flexion (96° vs. 108°; P = .049) and external rotation (15° vs. 21°; P = .04) compared with normal version. Inferiorly inclined glenoids had greater posterior subluxation (77%) than those with normal (67%; P = .001) and superior inclination (68%; P = .01). There were no relationships between excessive inclination or subluxation on ROM. In RCTA patients (n = 115), retroverted glenoids had greater superior inclination compared with normal glenoids (12.1° vs. 8.4°; P = .049). Version was associated with scapulohumeral subluxation (anteverted = mean 34% subluxation; normal version = 56.4% subluxation; retroverted = 71.2% subluxation; P < .0001). Retroverted glenoids had less flexion compared with normal version (70° vs. 90°; P = .048), less abduction (62°) than normal glenoids (88°; P = .03) and anteverted glenoids (115°; P = .03), and less abduction/internal rotation (7°) than normal (22°; P = .03) and anteverted glenoids (36°; P = .04). Superiorly inclined glenoids have more posterior subluxation than normally inclined glenoids (64% vs. 56.6%; P = .02). There was no relationship between inclination and ROM. Patients with posterior subluxation had less external rotation compared with those with a centered humeral head (10° vs. 22°; P = .009) and less abduction/internal rotation compared with anterior subluxation (12° vs. 35°; P = .02). There was no relationship between version, inclination, or subluxation with preoperative Western Ontario Osteoarthritis Scale or American Shoulder and Elbow Surgeons in patients with OA (P > .17) or RCTA (P > .31). ConclusionsAn interaction between version, inclination, and scapulohumeral subluxation in patients with OA and RCTA was found. Retroverted glenoids had decreased ROM measurements. RCTA shoulders with posterior scapulohumeral subluxation had decreased ROM. There was no relationship between glenoid and scapulohumeral morphology and patient-determined outcome scores. Level of evidenceLevel III; Retrospective Case-Control Prognosis Study

Preoperative differences in glenoid deformity, patient-determined outcomes, and range of motion as per disease type in shoulders undergoing total shoulder arthroplasty

BackgroundDiseases commonly treated with shoulder arthroplasty include the following: osteoarthritis, rotator cuff tear arthropathy (RCTA), and irreparable rotator cuff tears (IRCTs). Currently, there are few data available that identify if preoperative differences exist between these disorders in (1) computed tomography findings, (2) patient-determined outcome scores, and (3) range of motion. Understanding these disease-specific differences may allow for the development of disease-specific strategies in total shoulder arthroplasty to attempt to improve patient outcomes and implant longevity. MethodsA database of shoulders undergoing anatomic and reverse total shoulder arthroplasty was reviewed. The cohort was divided into three groups as per the disease treated with total shoulder arthroplasty: osteoarthritis, RCTA, and IRCT. The outcomes included preoperative range of motion, 3-dimensional computed tomography determination of glenoid morphology, and patient-determined outcomes including the Western Ontario Osteoarthritis Scale, American Shoulder and Elbow Surgeons score, Simple Shoulder Test, and the Single Assessment Numeric Evaluation. Differences between the groups were examined with analysis of variance with post hoc Tukey’s HSD test. The level of significance was P = .05. ResultsTwo hundred seventy-nine shoulders met inclusion and exclusion criteria. One hundred fifty-four shoulders had osteoarthritis, 94 shoulders had RCTA, and 21 shoulders had an IRCT. Patients with osteoarthritis had significantly greater mean glenoid retroversion (12.9°) than patients with an IRCT (7°; P = .03) and RCTA (8.6°; P = .004). Patients with osteoarthritis had significantly less mean superior glenoid inclination (5.9°) than patients with an IRCT (10.2°; P = .03) and RCTA (9.5°; P = .001). Patients with osteoarthritis had greater mean posterior humeral subluxation (68.9%) than patients with an IRCT (58.3%; P = .002) and RCTA (60.2%; P = .001).There was no difference in preoperative Western Ontario Osteoarthritis Scale (P = .86), American Shoulder and Elbow Surgeons score (P = .81), Simple Shoulder Test (P = .13), and Single Assessment Numeric Evaluation (P = .57). Patients with osteoarthritis had greater mean flexion (101°) than the IRCT (86°; P = .17) and RCTA groups (84°; P = .001). Patients with osteoarthritis had greater mean external rotation in the abducted position (54°) than the RCTA group (38°; P = .001) but similar to the IRCT group (48°; P = .68). The osteoarthritis group had inferior mean internal rotation in the abducted position (0.2°) compared with the RCTA (20.6°; P = .001). There were no differences in extension (P = .08), external rotation (P = .58), and abduction (P = .15). ConclusionShoulders with osteoarthritis have greater glenoid retroversion and posterior humeral subluxation, whereas shoulders with RCTA or IRCT have greater superior glenoid inclination. Patient-determined outcome scores do not differ between these diseases. Shoulders with osteoarthritis have greater baseline (1) flexion and (2) abducted external rotation but inferior abducted internal rotation.

Patient‐centered outcomes: Domain importance predicts health care use following physical therapy

Identifying patients with musculoskeletal pain who are at risk for additional health care use is important for improving the value of physical therapists' services. We previously identified three subgroups based on the importance attached by patients to improvements in outcome domains including a (1) Pain and Function Outcomes Important subgroup; (2) Pain Important subgroup; and (3) Multiple Outcome Domains Important subgroup. The primary aim was to determine whether subgroups based on patient-determined outcomes of importance predicted any additional pain-related health care use after an episode of physical therapy. A secondary aim was to determine if subgroup membership predicted use of specific services. Secondary analysis of a longitudinal cohort. Ambulatory outpatient physical therapy clinics. Two hundred forty-six patients seeking physical therapy recruited from the Optimal Screening for Prediction of Referral and Outcome (OSPRO) cohort study. Patients completed a demographic and health history questionnaire, numeric pain rating scale, region-specific disability measure, and Charlson Comorbidity Index. Subgroup membership was determined based on responses to the Patient Centered Outcome Questionnaire. At 1 year, patients reported use of health care since discharge from physical therapy. Separate logistic regression models determined whether subgroup membership predicted additional health care use. Compared to the Pain and Function Outcomes Important subgroup, the Pain Important subgroup had higher adjusted odds (95% confidence interval [CI]) for the primary outcome of any additional health care use (adjusted odds ratio [aOR]2.47, 95% CI 1.01-6.00) and secondary outcomes of opioid use (aOR 9.45, 95% CI 2.87-31.17), injection (aOR 4.09, 95% CI 1.25-13.41), and surgery (aOR 5.10, 95% CI 1.15-22.67). There were no significant differences in health care utilization between the Pain and Function Outcomes Important and Multiple Outcome Domains Important subgroups. In this cohort, patients with a singular focus on pain improvements were at higher risk for additional health care, including opioid use, injection, and surgery. These findings are exploratory and need to be confirmed in other cohorts.

The LORIS MyeliNeuroGene rare disease database for natural history studies and clinical trial readiness

BackgroundRare diseases are estimated to affect 150–350 million people worldwide. With advances in next generation sequencing, the number of known disease-causing genes has increased significantly, opening the door for therapy development. Rare disease research has therefore pivoted from gene discovery to the exploration of potential therapies. With impending clinical trials on the horizon, researchers are in urgent need of natural history studies to help them identify surrogate markers, validate outcome measures, define historical control patients, and design therapeutic trials.ResultsWe customized a browser-accessible multi-modal (e.g. genetics, imaging, behavioral, patient-determined outcomes) database to increase cohort sizes, identify surrogate markers, and foster international collaborations. Ninety data entry forms were developed including family, perinatal, developmental history, clinical examinations, diagnostic investigations, neurological evaluations (i.e. spasticity, dystonia, ataxia, etc.), disability measures, parental stress, and quality of life. A customizable clinical letter generator was created to assist in continuity of patient care.ConclusionsSmall cohorts and underpowered studies are a major challenge for rare disease research. This online, rare disease database will be accessible from all over the world, making it easier to share and disseminate data. We have outlined the methodology to become Title 21 Code of Federal Regulations Part 11 Compliant, which is a requirement to use electronic records as historical controls in clinical trials in the United States. Food and Drug Administration compliant databases will be life-changing for patients and families when historical control data is used for emerging clinical trials. Future work will leverage these tools to delineate the natural history of several rare diseases and we are confident that this database will be used on a larger scale to improve care for patients affected with rare diseases.

The American Shoulder and Elbow Surgeons score has excellent correlation with the Western Ontario Osteoarthritis score.

The purpose of this study was to compare the correlation, responsiveness, and responder and administrator burden of the American Shoulder and Elbow Surgeons (ASES) score with the Western Ontario Osteoarthritis of the Shoulder (WOOS) score for patients undergoing total shoulder arthroplasty. The goal was to determine whether one score was superior to the other to limit the use of multiple scoring measures when tracking patient outcomes. The hypothesis of this study was that for patients undergoing total shoulder arthroplasty, the WOOS score would have (1) a high level of correlation with the ASES score, (2) comparable responsiveness to the ASES score, and (3) a higher responder and administrator burden than the ASES score. We performed a retrospective review of a database of patients undergoing total shoulder arthroplasty in which the ASES score was recorded with the WOOS score. Correlations were determined using the Pearson coefficient. Subgroup analysis was performed to determine whether correlations differed in (1) preoperative outcome and (2) postoperative outcome determinations and by type of arthroplasty (anatomic vs. reverse). Responsiveness was determined by calculating the standardized response mean and the effect size of both scores. Responder and administrator burden was examined using 50 consecutive preoperative patients to determine the number of incorrectly completed WOOS and ASES scores. The correlation of the ASES and WOOS scores for all patients was excellent (n = 1218, r = 0.88, P < .0001). The correlation of the ASES and WOOS scores was excellent for patients undergoing anatomic total shoulder arthroplasty (n = 695, r = 0.71, P < .0001) and reverse total shoulder arthroplasty (n = 523, r = 0.88, P < .0001). The correlation of preoperative scores was strong-moderate (n = 606, r=0.62, P < .0001), and that of postoperative scores was strong-moderate (n = 612, r = 0.69, P < .0001). The standardized response mean (WOOS score, 2.1; ASES score, 2.1) and the effect size (WOOS score, 3.0; ASES score, 3.0) demonstrated comparable responsiveness. Twenty-six percent of the WOOS scores were completed incorrectly and were invalid compared with 0% of the ASES scores (P < .0001). There is excellent correlation and comparable responsiveness between the ASES score and WOOS score. Including these scores simultaneously when tracking patient-determined outcomes appears to be redundant and therefore unnecessary. Because there is higher responder and administrative burden for the WOOS score, we recommend use of the ASES score over the WOOS score in patients undergoing total shoulder arthroplasty.

Does the Presence of Chondral Lesions Negatively Affect Patient-Determined Outcomes After Arthroscopic Rotator Cuff Repair?

Background:There are limited data available to guide patients to their prognosis when glenohumeral chondral lesions are found during arthroscopic rotator cuff repair.Hypothesis:The primary hypothesis was that patients with glenohumeral chondral lesions will have inferior outcomes after arthroscopic rotator cuff repair compared with patients without chondral lesions. The secondary hypothesis was that patients with concomitant chondral lesions will have more severe preoperative symptoms compared with those without chondral lesions.Study Design:Cohort study; Level of evidence, 3.Methods:A retrospective analysis was performed of patients who underwent arthroscopic rotator cuff repair between 2008 and 2012. We examined the effects of chondral lesions on patient-determined outcomes, which included the Western Ontario Rotator Cuff Index (WORC), American Shoulder and Elbow Surgeons (ASES) score, Simple Shoulder Test (SST), Single Assessment Numeric Evaluation (SANE), and the Shoulder Activity Level (SAL). Shoulders without chondral lesions were compared with shoulders with chondral lesions to determine whether differences in severity of preoperative symptoms as well as postoperative improvements were statistically significant.Results:A total of 281 shoulders were included from 273 patients, with a mean follow-up of 3.7 years. In total, 90 shoulders (32%) had concomitant chondral lesions in the glenohumeral joint. The presence and degree of chondral damage were not associated with the severity of preoperative symptoms or the amount of improvement after arthroscopic rotator cuff repair, as determined by patient outcome scores. Shoulders with bipolar chondral lesions had less postoperative improvement in their outcome scores compared with shoulders with unipolar lesions, with significant differences found in the SST (P = .0005), the SANE (P = .005), and the SAL (P = .04). Regardless of this, the majority of shoulders with bipolar chondral lesions (80%-92%) had postoperative improvements that superseded the minimal clinically important difference of the ASES, WORC, and SANE.Conclusion:At a mean 3.7-year follow-up, the presence of chondral damage did not appear to negatively affect the improvement in patient-determined outcomes after arthroscopic rotator cuff repair. However, improvement in outcomes was negatively affected by the presence of bipolar chondral lesions.

The American Shoulder and Elbow Surgeons score highly correlates with the Simple Shoulder Test

There is no consensus to which patient-determined shoulder outcome scores should be considered when analyzing patient outcomes for either clinical or research purposes. The use of multiple outcome scores may be redundant and cause increased responder burden. The hypothesis of this study is that the American Shoulder and Elbow Surgeons score (ASES) will highly correlate with the Simple Shoulder Test (SST) for rotator cuff repair and total shoulder arthroplasty and have comparable responsiveness. If determined to be highly correlated, the use of these scores simultaneously may be redundant and one score may be eliminated. A retrospective review of the senior author's database of patients undergoing rotator cuff repair and total shoulder arthroplasty was reviewed in which the ASES was recorded simultaneously with the SST. Correlations were determined using the Pearson correlation coefficient (r > 0.7 excellent; r = 0.61-0.7 strong-moderate; r = 0.31-0.6 moderate; r = 0.2-0.3 poor) for all interactions between the 2 scores. Subgroup analysis was performed to determine if correlations differed in (1) preoperative outcome and (2) postoperative outcome determinations. Responsiveness was determined by calculating the standardized response meanand the effect size of both scores. There were a total of 1810 simultaneous measurements (both rotator cuff repair and total shoulder arthroplasty) of the ASES and SST. The correlation was excellent for the ASES and SST for all patients (n = 1810; r = 0.81; P < .0001). The correlation of preoperative scores was strong-moderate (n = 1191; r = 0.60; P < .0001), and the correlation of postoperative scores was excellent (n = 619; r = 0.78; P < .0001). Both scores were determined to be highly responsive, but both the standardized response mean (2.8 vs. 2.1) and the effect size (2.2 vs. 1.8) of the ASES were greater than those of the SST. In general, there was an excellent correlation between the ASES and the SST for all patients undergoing arthroscopic rotator cuff repair and total shoulder arthroplasty. Because there is an excellent correlation between the 2 scores, including these 2 scores simultaneously in tracking patient-determined outcomes appears to be redundant and therefore unnecessary. Because there is superior responsiveness of the ASES score compared with the SST, the authors recommend utilization of the ASES over the SST in patients undergoing rotator cuff repair and total shoulder arthroplasty.

Patient-Determined Outcomes After Arthroscopic Margin Convergence Rotator Cuff Repair

PurposeTo determine whether patients who require margin convergence would have equivalent postsurgical patient-determined scores compared with patients with standard rotator cuff repair. The secondary purpose of this study was to determine whether the short-term results found for patients with margin convergence repairs would be durable through medium-term follow-up.MethodsA retrospective analysis of patients undergoing arthroscopic rotator cuff repair was performed to examine the effects of marginal convergence on patient-determined outcomes (Western Ontario Rotator Cuff Index, American Shoulder and Elbow Surgeons score, Simple Shoulder Test, Single Assessment Numeric Evaluation, and Shoulder Activity Level). Patient-determined outcomes in patients who had margin convergence repairs were compared with patients who had standard rotator cuff repair. Prospective follow-up of patients that had margin convergence repairs was performed to determine whether patient-determined outcomes deteriorated over time.ResultsTwo-hundred-seventy-two patients had standard rotator cuff repairs and 9 patients had margin convergence rotator cuff repair (3.2%). All patients had significant improvements in their Western Ontario Rotator Cuff Index, American Shoulder and Elbow Surgeons score, Simple Shoulder Test, and Single Assessment Numeric Evaluation. Patients requiring margin convergence rotator cuff repair had similar preoperative and postoperative scores compared with patients with a standard rotator cuff repair. At a mean follow-up of 7.5 years, there was no change in outcome scores compared with the early follow-up time point (mean 3.3 years) for patients undergoing margin convergence.ConclusionsArthroscopic margin convergence repair techniques along with the treatment of concomitant pathologies result in similar patient-determined outcomes compared with standard rotator cuff repair techniques. These results appear to be durable and do not deteriorate from short-term to medium-term follow-up.Level of evidenceIII: Retrospective comparative study

Do patients who smoke tobacco have success with primary arthroscopic rotator cuff repair? A comparison with nonsmokers

It is recommended that patients cease smoking before rotator cuff repair. However, not all patients want to or are able to successfully cease smoking. This raises the question if these patients should be advised to pursue surgical intervention or if surgery should be contraindicated until patients successfully cease smoking. A retrospective analysis of patients undergoing rotator cuff repair was performed to examine the effects of smoking tobacco on patient-determined outcomes (Western Ontario Rotator Cuff Index [WORC], American Shoulder and Elbow Surgeons score [ASES], Simple Shoulder Test [SST], and Single Assessment Numeric Evaluation [SANE]). Patients who smoked tobacco at the time of surgery were compared with patients who were not smoking to determine if differences in (1) severity of preoperative and postoperative symptoms and (2) the postoperative improvements were statistically significant. Thirty-one patients were smokers and 205 were nonsmokers. Preoperative scores were worse for smokers compared with nonsmokers: WORC (32 vs. 43; P = .0002), ASES (32 vs. 43; P = .001), SST (3.5 vs. 4.6; P = .04), and SANE (34 vs. 38; P = .35). Postoperative scores were worse for smokers compared with nonsmokers: WORC (79 vs. 89; P = .001), ASES (82 vs. 89; P = .04), SST (9.0 vs. 10.2; P = .02), and SANE (84 vs. 89; P = .09). There were no significant differences in change in scores over time or percentage of patients achieving the minimal clinically important difference of the score between groups. From examining the patients' subjective patient-determined outcome scores, it does not appear that rotator cuff repair should be strictly contraindicated in active smokers. Postoperative improvements in smokers were similar to nonsmokers. Smokers have lower baseline preoperative and postoperative outcome scores compared with nonsmokers.

Do More Expensive Total Knee Arthroplasty Prostheses Provide Greater Improvements in Outcomes Over Less Expensive Prostheses Sold by a Physician-owned Distributorship?

It is unknown whether more expensive total knee prostheses provide better improvements in patient-determined outcomes compared with less expensive prostheses. A physician-owned distributorship (POD) was created with a goal to provide lower cost implants to hospitals as an alternative to higher cost prostheses sold by the large orthopaedic implant companies. The hypothesis was that lower cost total knee prostheses would have equivalent outcomes, while resulting in lower costs to the hospitals purchasing them compared with higher cost industry-supplied knee prostheses. From May 2013 until January 2015, a POD existed which included five surgeons that performed total knee arthroplasties and were willing to follow the outcomes to ensure quality. The POD sold two knee arthroplasty systems at a cost that was lower than that of the large industry companies. Surgeons were allowed to use either POD knees or industry knees at their own discretion. Patients were followed up prospectively to determine The Knee Injury and Osteoarthritis Outcome Score (KOOS) outcomes at 2 years and any incidence of knee complications that required surgery. Two hundred-nine knees (35.2%) had a POD knee implanted, and 385 knees had an industry knee implanted. Both POD knees and industry knees showed statistically significant improvements (P < 0.0001) for all subgroups of the KOOS. No statistically significant difference was observed in improvement in any subgroup of the KOOS between the groups. Knee complications requiring surgical intervention were similar (2.9% POD knees versus 3.6% industry knees; P = 0.58). Using lower cost POD knees saved $209,875.71. No difference was observed in improvements in outcomes or complications in the lower cost POD-supplied knees compared with the higher cost industry-supplied knees. Hospitals and surgeons may consider using lower cost prostheses because the increased cost of the prosthesis has not been correlated to improved outcomes. Level II therapeutic prospective cohort study.

Patient-determined outcomes after arthroscopic rotator cuff repair with and without biceps tenodesis utilizing the PITT technique

The percutaneous intra-articular transtendon technique (PITT) is a simple, rapid, and low-cost method of performing a biceps tenodesis. Few studies exist that examine the patient-determined outcomes of this technique in general or in patients undergoing arthroscopic rotator cuff repair (RCR) with and without biceps tenodesis. We hypothesized that patients undergoing an isolated arthroscopic RCR would have equivalent outcomes to those undergoing RCRs with PITT biceps tenodesis. We compared preoperative, patient-determined outcomes scores on patients undergoing primary arthroscopic RCR with and without a PITT biceps tenodesis with postoperative scores at a minimum of 2 years. These scores included the Western Ontario Rotator Cuff score (WORC), American Shoulder and Elbow Surgeons score (ASES), Single Assessment Numeric Evaluation (SANE), Simple Shoulder Test (SST), and Shoulder Activity Level (SAL). Indication for a concomitant biceps tenodesis was a partial long head biceps tendon tear or biceps instability/subluxation. A total of 153 patients underwent an isolated RCRand 131 patients underwent RCR with biceps tenodesis (RCRBT). Both groups had improvements in WORC, ASES, SANE, and SST (P < .0001) and deteriorations in the SAL (P ≤ .005). There was no difference in the change in outcome scores between the groups (RCRBT vs. RCR, respectively) for WORC (46 vs. 47; P = .85), ASES (46 vs. 47; P = .82), SANE (53 vs. 51; P = .35), SST (5.8 vs. 5.8; P = .93), and SAL (-0.9 vs. -1.4; P=.46). There was no difference between the groups in complications that required revision surgery (1.5% vs. 1.3%; P= .91). Arthroscopic PITT RCRBT is safe and effective with equivalent patient-determined outcomes compared with patients undergoing RCR without biceps tenodesis.

The position of sling immobilization influences the outcomes of anatomic total shoulder arthroplasty: a randomized, single-blind, prospective study

To date, no studies have been published that have assessed the optimal position of sling immobilization after anatomic total shoulder arthroplasty for glenohumeral osteoarthritis. Thirty-six patients undergoing anatomic total shoulder arthroplasty for osteoarthritis were randomized to a neutral rotation sling versus an internal rotation sling. The primary outcomes assessed included the Disabilities of the Arm, Shoulder and Hand score; Western Ontario Osteoarthritis of the Shoulder score; Single Assessment Numeric Evaluation score; visual analog scale (VAS) scores for pain and satisfaction; compliance ratings; and radiographic and range-of-motion measurements. Primary outcomes were assessed at baseline and postoperatively at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year. All patient-determined outcome scores for both groups revealed statistically significant improvements (P < .0001) from enrollment to final follow-up. There were statistically significant advantages to the neutral rotation sling group compared with the internal rotation sling group when we evaluated the improvements in (1) active external rotation (42° vs 25°, P = .03), (2) passive external rotation (44° vs 26°, P = .02), (3) passive horizontal adduction (7.7 cm vs 3.7 cm, P = .05), and (4) pain relief with passive adduction (VAS score, 6.2 cm vs 3.5 cm; P = .002). There was a trend toward greater improvements in the neutral rotation sling group when we measured (1) active horizontal adduction (8.3 cm vs 2.9 cm, P = .06) and (2) active internal rotation behind the back (18 cm vs 11.1 cm, P = .09). At 2 weeks, the neutral rotation sling group had significantly less night pain than the internal rotation sling group (mean VAS score, 18 mm vs 34 mm; P = .047). Neutral rotation sling use after anatomic total shoulder arthroplasty resulted in statistically significant improvements in external rotation and adduction, as well as decreased night pain, compared with an internal rotation sling.

SCAPULAR SUBSTITUTION AFTER ROTATOR CUFF REPAIR CORRELATES WITH POSTOPERATIVE PATIENT OUTCOME

Scapular substitution is an alteration of scapulohumeral kinematics that may occur when patients have shoulder pain or dysfunction. These abnormal scapular kinematic patterns have been recognized in patients with rotator cuff tears. It remains unknown if 1) normal scapular kinematics can be restored with rehabilitation after rotator cuff repair surgery and 2) abnormal scapular kinematics are associated with inferior patient-determined outcome scores, range of motion, or strength. The purpose of this study was to determine 1) if scapular substitution can be decreased or improved with rehabilitation after rotator cuff repair surgery and 2) if the presence or amount of scapular substitution was correlated with patient-determined outcome scores, range of motion, or strength after rotator cuff repair surgery. Retrospective review of prospectively collected data (LOE IV). Forty-eight patients who underwent post-operative rehabilitation after an arthroscopic rotator cuff repair were reviewed for this study. The outcomes measures of interest included: patient-determined outcome scores (WORC, Simple Shoulder Test, the ASES Score, the Shoulder Activity Score, and the SANE rating), identification and quantification of scapular substitution, active range of motion, and strength. Outcomes were prospectively collected up to 12 months after surgery and assessed retrospectively. As patients progress through their first year of rehabilitation from a rotator cuff repair, the amount of scapular substitution decreases but remains statistically significantly greater than the contralateral, asymptomatic side. At all post-operative time points, patients with scapular substitution, (determined subjectively by a physical therapist), had 1) inferior WORC, ASES, SANE, and SST scores, 2) inferior flexion, abduction, and external rotation range of motion, and 3) inferior scaption strength compared to those patients without subjective scapular substitution. Rehabilitation decreases but does not normalize the amount of scapular substitution up to one year after rotator cuff repair. Subjective identification of scapular substitution is associated with inferior patient-determined outcome scores, range of motion, and strength. 4 - Prognosis study.