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Nevin Manimala Statistics

Comparative Studies in the Shoulder Literature Lack Statistical Robustness: A Fragility Analysis

Arthrosc Sports Med Rehabil. 2021 Oct 12;3(6):e1899-e1904. doi: 10.1016/j.asmr.2021.08.017. eCollection 2021 Dec.

ABSTRACT

PURPOSE: Evidenced-based decision-making is rooted in comparative clinical studies; however, a small number of outcome event reversals have the potential to change study significance. The purpose of this study was to determine the utility of applying fragility analysis to comparative studies in the published orthopaedic shoulder literature.

METHODS: Comparative clinical shoulder research studies reporting 1:1 dichotomous categorical data were analyzed in 6 leading orthopaedic journals between 2006 and 2016. Statistical significance was defined as a P value of less than .05. The fragility index (FI) for each study outcome was determined by the number of event reversals required to change the P value to either greater or less than 0.05, thus changing the study conclusions. The associated fragility quotient (FQ) was determined by dividing the FI by the total population comprising a particular outcome.

RESULTS: Of the 23,897 studies screened, 3,591 met search criteria, with 198 comparative studies ultimately included for analysis, 67 of which were randomized controlled trials. There were 357 total outcome events with 74 reported as significant and 283 as not significant. The FI was 4 (IQR 2-6) with an associated FQ of 0.066 (interquartile range [IQR] 0.038-0.102). There was no difference in statistical fragility between randomized and nonrandomized trials with both revealing a FI of 4 and FQ of 0.068 (IQR 0.044-0.107) and 0.065 (IQR 0.031-0.101), respectively.

CONCLUSIONS: This current analysis reveals that comparative shoulder studies published in six leading orthopaedic journals are at risk of statistical fragility. As such, contemporary clinical shoulder literature may not be as robust as traditionally perceived with the reversal of only a few outcome events required to change study significance. Therefore, we advocate the reporting of both FI and FQ in addition to the P value as statistical complements to all comparative investigations to provide a more comprehensive understanding of trial stability and significance in the published shoulder literature.

CLINICAL RELEVANCE: Comparative study designs are commonly employed in shoulder research. Several studies in both the general medical and orthopaedic literature have identified a lack of statistical robustness through comprehensive fragility analysis. Our findings demonstrate the P value may be an inadequate independent statistical metric requiring the complement of a FI and FQ to aid in the interpretation and understanding of study significance for clinical decision-making.

PMID:34977646 | PMC:PMC8689245 | DOI:10.1016/j.asmr.2021.08.017

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Nevin Manimala Statistics

Both Open and Arthroscopic Latarjet Result in Excellent Outcomes and Low Recurrence Rates for Anterior Shoulder Instability

Arthrosc Sports Med Rehabil. 2021 Nov 4;3(6):e1955-e1960. doi: 10.1016/j.asmr.2021.09.017. eCollection 2021 Dec.

ABSTRACT

PURPOSE: The purpose of this study is to evaluate the patient-reported outcomes of open Latarjet (OL) compared to arthroscopic Latarjet (AL) for anterior shoulder instability.

METHODS: A retrospective review of patients who underwent either OL or AL for anterior shoulder instability between 2011 and 2019 was performed. Recurrent instability, visual analog scale (VAS) score, Shoulder Instability-Return to Sport after Injury (SIRSI), Subjective Shoulder Value (SSV), Western Ontario Shoulder Instability (WOSI) score, patient satisfaction, willingness to undergo surgery again, and return to work/sport (RTW/RTS) were evaluated. A P value of < .05 was considered to be statistically significant.

RESULTS: Our study included 102 patients in total; 72 patients treated with OL, and 30 treated with AL. There were no demographic differences between the two groups (P > .05 for all). At final follow up (mean of 51.3 months), there was no difference between those that underwent OL or AL in the reported WOSI, VAS, VAS during sports, SSV, and SIRSI scores, nor in patient satisfaction, or whether they would undergo surgery again (P > .05). Overall, there was no significant difference in the total rate of RTP (65% vs 60.9%; P = .74), or timing of RTP (8.1 months vs 7 months; P = .35). Additionally, there was no significant difference in the total rate of RTW (93.5% vs 95.5%; P = .75). Overall, 3 patients in the OL group and 2 patients in the AL group had recurrent instability events (6.9% vs 6.7%; P = .96), with no significant difference in the rate of recurrent dislocation (4.2% vs 3.3%; P = .84).

CONCLUSION: In patients with anterior shoulder instability, both the OL and AL are reliable treatment options, with a low rate of recurrent instability, and similar patient-reported outcomes.

PMID:34977653 | PMC:PMC8689257 | DOI:10.1016/j.asmr.2021.09.017

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Nevin Manimala Statistics

Preoperative Patient-Reported Outcomes Measurement Information System Computerized Adaptive Testing (PROMIS CAT) Scores Predict Achievement of Minimum Clinically Important Difference Following Anterior Cruciate Ligament Reconstruction Using an Anchor-Based Methodology

Arthrosc Sports Med Rehabil. 2021 Oct 14;3(6):e1891-e1898. doi: 10.1016/j.asmr.2021.09.004. eCollection 2021 Dec.

ABSTRACT

PURPOSE: To determine the change in Patient-Reported Outcomes Measurement Information System Computerized Adaptive Testing (PROMIS CAT) scores for physical function, pain interference, and depression that constitute minimum clinically important difference (MCID) using an anchor-based technique and to identify pre-operative clinical thresholds in anchor-based MCID that predict likelihood of achieving MCID following anterior cruciate ligament (ACL) reconstruction.

METHODS: Adult patients aged 18 years or older undergoing ACL reconstruction that completed both preoperative and postoperative PROMIS CAT assessments and an anchor-based questionnaire were identified over a 23-month period. Anchor-based MCID was determined for PROMIS CAT forms for physical function (PROMIS PF CAT), pain interference (PROMIS PI CAT), and depression (PROMIS D CAT).

RESULTS: A total of 137 patients were included for statistical analysis, with pre-operative PROMIS CAT forms completed 27.9 ± 31.2 days before surgery and 492.5 ± 219.9 days postoperatively on average. Statistically significant improvements were observed for all PROMIS CAT domains. PROMIS PF CAT improved from 39.5 ± 8.2 to 55.0 ± 9.7 (P < .0005), PROMIS PI CAT from 59.8 ± 7.2 to 48.2 ± 8.3 (P < .0005), and PROMIS D CAT from 47.9 ± 8.8 to 41.5 ± 8.6 (P < .0005). Anchor-based MCID for each PROMIS CAT form was calculated to be +4.5, -5.4, and -4.1 for PROMIS PF CAT, PROMIS PI CAT, and PROMIS D CAT, respectively. Mean difference between preoperative and postoperative PROMIS CAT scores exceeded MCID for all domains. The percentage of patients achieving MCID for PROMIS PF CAT, PROMIS PI CAT, and PROMIS D CAT was 85%, 72%, and 55%, respectively. After introduction of 95% specificity cutoffs, the percentage of patients achieving MCID for PROMIS PF CAT, PROMIS PI CAT, and PROMIS D CAT increased to 100% (<35.6 cutoff score), 92% (>65.7 cutoff score), and 83% (>57.5 cutoff score), respectively.

CONCLUSIONS: According to anchor-based analysis of PROMIS CAT MCID, ACL reconstruction is effective in improving physical function, pain interference, and depression symptoms. In addition, preoperative PROMIS CAT scores can predict the likelihood of achieving MCID postoperatively.

LEVEL OF EVIDENCE: Level IV, prognostic case series.

PMID:34977645 | PMC:PMC8689251 | DOI:10.1016/j.asmr.2021.09.004

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Nevin Manimala Statistics

Elbow Torque May be Predictive of Anatomic Adaptations to the Elbow After a Season of Collegiate Pitching: A Dynamic Ultrasound Study

Arthrosc Sports Med Rehabil. 2021 Oct 9;3(6):e1843-e1851. doi: 10.1016/j.asmr.2021.08.012. eCollection 2021 Dec.

ABSTRACT

PURPOSE: To determine whether elbow torque was associated with anatomic adaptations of the medial elbow following a season of competitive pitching.

METHODS: Pitchers from 3 collegiate baseball teams were recruited during the preseason for participation. Before the season, pitchers were recorded throwing 5 “game-speed” fastball pitches from a standard distance off a mound while wearing a wearable sensor baseball compression sleeve that calculates elbow torque, arm speed, arm slot, and arm rotation. Participants subsequently underwent dynamic ultrasound imaging of the medial elbow, including measurements of the ulnar collateral ligament (UCL) and ulnohumeral joint space to assess elbow laxity. Following a full season of competitive pitching, all testing was repeated, and statistical analysis comparing preseason to postseason sonographic findings was performed.

RESULTS: Twenty-eight collegiate pitchers underwent preseason sonographic and kinematic testing. Nineteen pitchers were available for postseason testing. The average age (standard deviation) and playing experience was 19.9 (1.2) and 14.7 (1.5) years. Compared with preseason, there were significant increases in postseason UCL thickness (1.92 ± 0.09 vs 1.56 ± 0.09 mm, P < .01) and elbow laxity (1.77 ± 0.23 vs 1.15 ± 0.22 mm, P = .028) after a season of pitching. No significant changes in pitching kinematic measurements were observed between preseason and postseason testing. Preseason pitching kinematic measurements were significantly associated with increased UCL thickness (arm slot: beta estimate -0.03 ± 0.01, P = .011) and reduction in elbow laxity (elbow torque: beta estimate -0.03 ± 0.01, P = .04) after a season of pitching. Pitchers with increased body weight and arm length demonstrated reduced medial elbow torque during pitching (P < .05).

CONCLUSIONS: After a season of competitive pitching, adaptive changes of the medial elbow were demonstrated on dynamic ultrasound. However, the influence of pitching kinematic measurements on these adaptations are of small magnitude and unknown clinical significance. Although wearable sensor technology may have value in trending individual pitcher kinematics, no discrete threshold appears to predict the development of adaptive changes at the elbow.

LEVEL OF EVIDENCE: Level II, prospective observational study.

PMID:34977639 | PMC:PMC8689260 | DOI:10.1016/j.asmr.2021.08.012

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Nevin Manimala Statistics

Retrospective Analysis of Patients Undergoing Arthroscopic Rotator Cuff Repair at a Single Institution Yields a 0.11% Postoperative Infection Rate

Arthrosc Sports Med Rehabil. 2021 Nov 1;3(6):e1853-e1856. doi: 10.1016/j.asmr.2021.08.014. eCollection 2021 Dec.

ABSTRACT

PURPOSE: To establish an infection rate following primary arthroscopic rotator cuff repair (ARCR) from a single institutional database and to ascertain whether there is a relationship between the use of preoperative corticosteroid injection (CSI) and the risk of postoperative infection.

METHODS: All medical records at a single institution were retrospectively reviewed to identify patients who had undergone arthroscopic repair from January 2016 to December 2018. Patient charts were reviewed for CSI treatment within 6 months of surgery, superficial or deep infection within 2 months postoperatively, and specific treatment of the infection. Patient characteristics were summarized by descriptive statistics using means with standard deviations for continuous variables and frequencies with percentages for categorical variables. A χ2 correlation analysis was performed to determine the association between receiving an injection and having an infection.

RESULTS: A total of 1773 patients were included for analysis with an average age of 59.24 ± 9.4 years. The overall infection rate was 0.11% (2/1773 patients). Both patients were treated with oral antibiotics. Of the included patients, 616 had a preoperative CSI within 6 months of their surgery, and 102 injections were administered within 1 month of surgery. None of these patients had a postoperative infection. A χ2 correlation analysis showed a negligible relationship between preoperative injections and postoperative infection (φ = 0.02, χ2 = 0.84).

CONCLUSIONS: Through this single-institution, large cohort retrospective review, we found an overall 0.11% rate of postoperative infection following primary arthroscopic RCR. In addition, we found no correlation between the use of preoperative CSI ahead of elective ARCR at any time point and risk of developing a postoperative infection. Infection is uncommon following ARCR, and preoperative steroid injection did not increase infection risk in our study population.

LEVEL OF EVIDENCE: Level IV, therapeutic case series.

PMID:34977640 | PMC:PMC8689265 | DOI:10.1016/j.asmr.2021.08.014

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Nevin Manimala Statistics

Significant Improvement in Shoulder Function and Pain in Patients Following Biologic Augmentation of Revision Arthroscopic Rotator Cuff Repair Using an Autologous Fibrin Scaffold and Bone Marrow Aspirate Derived From the Proximal Humerus

Arthrosc Sports Med Rehabil. 2021 Oct 30;3(6):e1819-e1825. doi: 10.1016/j.asmr.2021.08.009. eCollection 2021 Dec.

ABSTRACT

PURPOSE: To clinically evaluate patients who underwent a biologic augmentation technique in revision arthroscopic rotator cuff repair using an autologous fibrin scaffold and concentrated stem cells isolated from bone marrow aspirate (BMA) obtained from the proximal humerus.

METHODS: This is a retrospective review of prospectively collected data from patients who underwent biologic augmentation of revision arthroscopic rotator cuff repair using an autologous fibrin scaffold and BMA obtained from the proximal humerus between 2014 and 2015. Minimum follow-up was 12 months. Outcome measures were collected preoperatively and postoperatively including range of motion as well as American Shoulder and Elbow Surgeons Shoulder Form, Simple Shoulder Test, single assessment numeric evaluation, and visual analog score. In addition, BMA samples of each patient were assessed for the number of nucleated cells and colony-forming units. Regression analysis was performed to investigate whether the number of nucleated cells and colony-forming units had an influence on outcome and failure.

RESULTS: Ten patients who underwent biologic augmentation of revision arthroscopic rotator cuff repair using an autologous fibrin scaffold and concentrated BMA obtained from the proximal humerus between 2014 and 2015 were included. The mean follow-up time was 30.7 (range: 12-49) months. Four patients were revised at final follow-up. Postoperative clinical scores improved significantly: American Shoulder and Elbow Surgeons (28.1 ± 5.4 to 60.9 ± 9.0; P < .01), single assessment numeric evaluation (6.6 ± 2.3 to 65.1 ± 10.9; P < .01), visual analog scale (7.2 ± 0.9 to 3.1 ± 0.9; P < .01), and Simple Shoulder Test (1.6 ± 0.5 to 10.3 ± 5.7; P < .01). Postoperative range of motion increased significantly with regard to flexion (97.0 ± 13.6 to 151.0 ± 12.2; P < .01) and abduction (88.0 ± 14.0 to 134.0 ± 15.1; P = .038) but not with external rotation (38.0 ± 5.7 to 50.5 ± 6.5; P = .16). Less pain was correlated to an increased number of nucleated cells (P = .026); however, there was no correlation between failure rate and number of nucleated cells (P = .430).

CONCLUSIONS: Patients who underwent biologic augmentation of revision arthroscopic rotator cuff repair using an autologous fibrin scaffold and concentrated BMA demonstrated a significant improvement in shoulder function along with reduction of pain. However, the overall revision rate for this procedure was 40%.

LEVEL OF EVIDENCE: Level IV, therapeutic case series.

PMID:34977636 | PMC:PMC8689277 | DOI:10.1016/j.asmr.2021.08.009

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Nevin Manimala Statistics

Good Clinical Success Rates Are Seen 5 Years After Meniscal Repair in Patients Regularly Undertaking Extreme Flexion

Arthrosc Sports Med Rehabil. 2021 Nov 23;3(6):e1835-e1842. doi: 10.1016/j.asmr.2021.08.011. eCollection 2021 Dec.

ABSTRACT

PURPOSE: To report the functional and radiologic outcomes of meniscal repair healing in a cohort of patients with a high demand for loaded extreme flexion angles after undergoing meniscal repair.

METHODS: We performed a retrospective clinical and radiologic evaluation of patients who perform extreme knee flexion activities on a daily basis at a minimum follow-up of 2 years after meniscal repair. International Knee Documentation Committee, Lysholm, and Tegner scores were obtained, and clinical examinations and radiologic (magnetic resonance imaging and radiography) evaluations were performed.

RESULTS: Of 47 eligible patients, 39 patients (40 knees) were available for review with an average follow-up time of 5 years (range, 2-9 years). The average age was 26.7 years (range, 19-39 years); 38 patients were men. The average time from injury to surgery was 20.9 months (range, 3 days to 120 months). Associated anterior cruciate ligament injury was present in 31 knees, but only 20 underwent simultaneous anterior cruciate ligament surgery. The mean International Knee Documentation Committee score was 88.9 (range, 53-99). The mean Lysholm score was 90.9 (range, 48-100). The mean Tegner activity level dropped from 6.18 before injury to 5.51 at the time of evaluation. According to the Barrett criteria for clinical outcomes, complete healing was observed in 29 of 40 knees (72.5%). There was a statistically significant correlation between the functional outcomes and the clinical outcomes (P = .008). On magnetic resonance imaging, 22 of 38 knees (57.9%) showed completely healed menisci.

CONCLUSIONS: The results of this study suggest that loaded deep knee flexion may be safe after a period of restricted rehabilitation, and clinical and radiologic tissue healing is independent of the overall functional outcome.

LEVEL OF EVIDENCE: Level IV, case series with subgroup analysis.

PMID:34977638 | PMC:PMC8689273 | DOI:10.1016/j.asmr.2021.08.011

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Nevin Manimala Statistics

The Glenolabral Articular Disruption Lesion Is a Biomechanical Risk Factor for Recurrent Shoulder Instability

Arthrosc Sports Med Rehabil. 2021 Sep 15;3(6):e1803-e1810. doi: 10.1016/j.asmr.2021.08.007. eCollection 2021 Dec.

ABSTRACT

PURPOSE: To investigate the biomechanical effect of a glenolabral articular disruption (GLAD) lesion on glenohumeral laxity.

METHODS: Human cadaveric glenoids (n = 10) were excised of soft tissue, including the labrum to focus on the biomechanical effects of osteochondral surfaces. Glenohumeral dislocations were performed in a robotic test setup, while displacement forces and three-dimensional morphometric properties were measured. The stability ratio (SR), a biomechanical characteristic for glenohumeral stability, was used as an outcome parameter, as well as the path of least resistance, determined by a hybrid robot displacement. The impacts of chondral and bony defects were analyzed related to the intact glenoid. Statistical comparison of the defect states on SR and the path of least resistance was performed using repeated-measures ANOVA and Tukey’s post hoc test for multiple comparisons (P < .05). The relationship between concavity depth and SR was approximated in a nonlinear regression.

RESULTS: The initial SR of the intact glenoid (28.3 ± 7.8%) decreased significantly by 4.7 ± 3% in case of a chondral defect (P = .002). An additional loss of 3.2 ± 2.3% was provoked by a 20% bony defect (P = .004). The path of least resistance was deflected significantly more inferiorly by a GLAD lesion (2.9 ± 1.8°, P = .002) and even more by a bony defect (2.5 ± 2.9°, P = .002). The nonlinear regression with concavity depth as predictor for the SR resulted in a high correlation coefficient (r = .81).

CONCLUSIONS: Chondral integrity is an important contributor to the SR. Chondral defects as present in GLAD lesions may cause increased laxity, influence the humeral track on the glenoid during dislocation, and represent a biomechanical risk factor for a recurrent instability.

CLINICAL RELEVANCE: Cartilage deficiency corresponding to GLAD lesions may be a risk factor for impaired surgical outcomes.

PMID:34977634 | PMC:PMC8689271 | DOI:10.1016/j.asmr.2021.08.007

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Nevin Manimala Statistics

Preoperative Dynamic Hip Examination Under Fluoroscopic Guidance Enhances the Understanding of Femoroacetabular Impingement Pathology and Treatment Planning

Arthrosc Sports Med Rehabil. 2021 Sep 11;3(6):e1599-e1606. doi: 10.1016/j.asmr.2021.07.015. eCollection 2021 Dec.

ABSTRACT

PURPOSE: To review the relative accuracy of preoperative magnetic resonance imaging (MRI) and fluoroscopically guided examination-under-sedation (EUS) findings and to explore the validity of the anterior acetabular sector angle (AASA) as a radiologic MRI-based marker of anterior acetabular coverage in pincer-type impingement.

METHODS: A cohort of 150 consecutive patients undergoing primary hip arthroscopy for femoroacetabular impingement (FAI) in 2018 to 2019 was reviewed. The inclusion criteria were pure FAI unilateral symptomatic pathology and the availability of complete data sets (MRI, EUS, and intraoperative records). Preoperative MRI and EUS findings were compared with gold-standard intraoperative arthroscopic findings, specifically evaluating the alpha angle in the presence of cam lesions, AASA in the presence of pincer lesions, as well as soft-tissue lesions. An alpha angle greater than 50° and an AASA greater than 65° were deemed pathologic.

RESULTS: The patient cohort included 78 women and 72 men with an average age of 38 years (range, 18-53 years). Intraoperatively, pincer lesions were present in 20% of patients; cam lesions, 26%; and mixed impingement, 54%. MRI versus EUS correctly identified pincer lesions in 36% versus 89% of cases and identified cam lesions in 44% versus 77% of cases. MRI findings characterizing labral tears and articular cartilage pathology were accurate in 80% and 10% of cases, respectively. Although there was no difference in the AASA between pure pincer- and mixed-type impingements (62° and 63°, respectively; P = .62), there was a statistically significant difference in reported AASA values between pure cam-type impingement and impingement involving the presence of pincer lesions (57° and 63°, respectively; P = .03). Furthermore, 31% of patients with intraoperatively identified pincer lesions had an AASA of 60° to 65°.

CONCLUSIONS: Fluoroscopic EUS is accurate in characterizing FAI pathology. In addition, MRI is useful to diagnose or rule out non-FAI pathology, ascertain labral pathology, and outline hip alignment. These methods of preoperative planning are complementary.

LEVEL OF EVIDENCE: Level IV, therapeutic case series.

PMID:34977611 | PMC:PMC8689150 | DOI:10.1016/j.asmr.2021.07.015

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Nevin Manimala Statistics

Local Recurrence After Minimally Invasive Curettage For Primary Giant Cell Tumor of Bone With Perioperative Bisphosphonate Is Comparable to Open Curettage: Retrospective Comparison With 9-Year Follow-Up

Arthrosc Sports Med Rehabil. 2021 Aug 31;3(6):e1729-e1736. doi: 10.1016/j.asmr.2021.07.032. eCollection 2021 Dec.

ABSTRACT

PURPOSE: To compare the long-term oncological outcome of minimally invasive curettage (MIC) with conventional open curettage (OC).

METHODS: We studied patients with primary giant cell tumor of bone (GCTB) of extremities who underwent intralesional tumor curettage and cementation and perioperative bisphosphonates from February 2003 to June 2016. All cases were histology-confirmed diagnoses of GCTB. Recurrent GCTB, malignant GCTB, cases in the axial skeleton (pelvis and spine), or cases with bone grafting of the curetted cavity were excluded. The local recurrence-free (LR-free) estimates of the OC and MIC groups were compared. The hazard ratio of a local recurrence was calculated for the various factors of the patients, disease, and treatment.

RESULTS: At a mean follow-up of 8.8 years, the overall LR rate was 24.2% (8 out of 33 patients). There was no statistical difference in LR in MIC and OC groups (27.8 % vs 20%; P = .6). The mean time to LR was 33.1 months (8 to 75). The operative time was comparable in both MIC and OC groups. None of the risk factors studied led to a significantly higher hazard of LR.

CONCLUSIONS: At a long-term follow-up of 9 years, MIC showed similar LR-free survival to OC. Combining bisphosphonates and MIC with a less invasive approach showed reasonable LR-free survival in long-term follow-up.

LEVEL OF EVIDENCE: Level III, retrospective cohort study.

PMID:34977627 | PMC:PMC8689217 | DOI:10.1016/j.asmr.2021.07.032