Aims. The aim of this study was to investigate the outcomes of arthroscopic decompression of calcific tendinitis performed without repairing the rotator cuff defect. Methods. A total of 99 patients who underwent treatment between December 2013 and August 2019 were retrospectively reviewed. Visual analogue scale (VAS) and American Shoulder and Elbow Surgeons (ASES) scores were reviewed pre- and postoperatively according to the location, size, physical characteristics, and radiological features of the calcific deposits. Additionally, the influence of any residual calcific deposits shown on postoperative radiographs was explored. The healing rate of the unrepaired cuff defect was determined by reviewing the 29 patients who had follow-up MRIs. Results. Statistically significant improvement from pre- to postoperation was seen in all VAS and ASES scores for each group, but no statistical differences were seen between the postoperative scores according to the differences in the features of the calcific deposits. When residual calcification was observed postoperatively, the mean ASES and VAS (rest) scores improved significantly to 95.0 (SD 5.6) and 0.0 (SD 0.0), respectively (p = 0.006 and p < 0.001), and did not differ from those who had the complete removal. Of 29 patients who had follow-up MRIs, six (20.7%) showed signs of an interstitial tear. This group’s mean postoperative ASES and VAS (rest) scores improved to excellent levels of 96.0 (SD 3.7) and 0.0 (SD 0.0), respectively, and were similar to those of the 23 patients with normal MRI appearances. Conclusion. Arthroscopic removal of calcific deposits without repairing the rotator cuff defect resulted in significant improvement in function and pain level, regardless of the deposit’s location, size, type, and whether or not complete excision was achieved. Despite leaving the defects unrepaired, in the limited number of patients with follow-up MRIs, 23 of 29 patients (79.3%) showed good healing, and the rest, who had persistent signs of interstitial defects on the MRIs, still had excellent outcomes. The removal of calcific deposits without repairing the cuff defects provided excellent outcomes. Cite this article: Bone Joint J 2023;105-B(6):663–667

Aims. The aims of this study were to validate the minimal clinically important difference (MCID) and patient-acceptable symptom state (PASS) thresholds for Western Ontario Shoulder Instability Index (WOSI), Rowe score, American Shoulder and Elbow Surgeons (ASES), and visual analogue scale (VAS) scores following arthroscopic Bankart repair, and to identify preoperative threshold values of these scores that could predict the achievement of MCID and PASS. Methods. A retrospective review was conducted on 131 consecutive patients with anterior shoulder instability who underwent arthroscopic Bankart repair between January 2020 and January 2023. Inclusion criteria required at least one episode of shoulder instability and a minimum follow-up period of 12 months. Preoperative and one-year postoperative scores were assessed. MCID and PASS were estimated using distribution-based and anchor-based methods, respectively. Receiver operating characteristic curve analysis determined preoperative patient-reported outcome measure thresholds predictive of achieving MCID and PASS. Results. MCID thresholds were determined as 169.6, 6.8, 7.2, and 1.1 for WOSI, Rowe, ASES, and VAS, respectively. PASS thresholds were calculated as ≤ 480, ≥ 80, ≥ 87, and ≤ 1 for WOSI, Rowe, ASES, and VAS, respectively. Preoperative thresholds of ≥ 760 (WOSI) and ≤ 50 (Rowe) predicted achieving MCID for WOSI score (p < 0.001). Preoperative thresholds of ≤ 60 (ASES) and ≥ 2 (VAS) predicted achieving MCID for VAS score (p < 0.001). A preoperative threshold of ≥ 40 (Rowe) predicted achieving PASS for Rowe score (p = 0.005). Preoperative thresholds of ≥ 50 (ASES; p = 0.002) and ≤ 2 (VAS; p < 0.001) predicted achieving PASS for the ASES score. Preoperative thresholds of ≥ 43 (ASES; p = 0.046) and ≤ 4 (VAS; p = 0.024) predicted achieving PASS for the VAS. Conclusion. This study defined MCID and PASS values for WOSI, Rowe, ASES, and VAS scores in patients undergoing arthroscopic Bankart repair. Higher preoperative functional scores may reduce the likelihood of achieving MCID but increase the likelihood of achieving the PASS. These findings provide valuable guidance for surgeons to counsel patients realistically regarding their expectations. Cite this article: Bone Joint J 2024;106-B(10):1118–1124

Aims. In patients with a failed radial head arthroplasty (RHA), simple removal of the implant is an option. However, there is little information in the literature about the outcome of this procedure. The aim of this study was to review the mid-term clinical and radiological results, and the rate of complications and removal of the implant, in patients whose initial RHA was undertaken acutely for trauma involving the elbow. Methods. A total of 11 patients in whom removal of a RHA without reimplantation was undertaken as a revision procedure were reviewed at a mean follow-up of 8.4 years (6 to 11). The range of motion (ROM) and stability of the elbow were recorded. Pain was assessed using a visual analogue scale (VAS). The functional outcome was assessed using the Mayo Elbow Performance Score (MEPS), the Oxford Elbow Score (OES), and the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH). Radiological examination included the assessment of heterotopic ossification (HO), implant loosening, capitellar erosion, overlengthening, and osteoarthritis. Complications and the rate of further surgery were also recorded. Results. The indications for removal of the implant were stiffness in five patients, aseptic loosening in five, and pain attributed to the RHA in three. The mean time interval between RHA for trauma to removal was ten months (7 to 21). Preoperatively, three patients had overlengthening of the implant, three had capitellar erosion, six had HO, and four had radiological evidence of loosening. At the final follow-up, the mean the flexion-extension arc improved significantly by 38.2° (95% CI 20 to 59; p = 0.002) and the mean arc of prono-supination improved significantly by 20° (95% CI 0 to 72.5; p = 0.035). The mean pain VAS score improved significantly by 3.5 (95% CI 2 to 5.5; p = 0.004). The mean MEPS improved significantly by 27.5 (95% CI 17.5 to 42.5; p = 0.002). The mean OES improved significantly by 9 (95% CI 2.5 to 14; p = 0.012), and the mean DASH score improved significantly by 23.5 (95% CI 7.5 to 31.6; p = 0.012). Ten patients (91%) had HO and osteoarthritis. Two patients underwent further surgery due to stiffness and pain, respectively. Conclusion. Simple removal of the implant at revision surgery following a failed RHA introduced following trauma provides satisfactory mid-term results with an acceptable risk of complications. Osteoarthritis, instability, and radioulnar impingement were not problems in this series. Cite this article: Bone Joint J 2024;106-B(11):1327–1332

Aims. Stemless humeral implants have been developed to overcome stem-related complications in total shoulder arthroplasty (TSA). However, stemless implant designs may hypothetically result in less stable initial fixation, potentially affecting long-term survival. The aim of this study is to investigate early fixation and migration patterns of the stemless humeral component of the Simpliciti Shoulder System and to evaluate clinical outcomes. Methods. In this prospective cohort study, radiostereometric analysis (RSA) radiographs were obtained in 24 patients at one day, six weeks, six months, one year, and two years postoperatively. Migration was calculated using model-based RSA. Clinical outcomes were evaluated using the visual analogue scale (VAS), the Oxford Shoulder Score (OSS), the Constant-Murley Score (CMS), and the Disabilities of the Arm, Shoulder and Hand (DASH) score. Results. At two years, median translation along the x-, y-, and z-axis was -0.12 mm (interquartile range (IQR) -0.18 to 0.02), -0.17 mm (IQR -0.27 to -0.09), and 0.09 mm (IQR 0.02 to 0.31). Median rotation around the x-, y-, and z-axis was 0.12° (IQR -0.50 to 0.57), -0.98° (IQR -1.83 to 1.23), and 0.09° (IQR -0.76 to 0.30). Overall, 20 prostheses stabilized within 12 months postoperatively. Four prostheses showed continuous migration between 12 and 24 months. At two-year follow-up, with the exception of one revised prosthesis, all clinical scores improved significantly (median VAS difference at rest: -3.0 (IQR -1.5 to -6.0); OSS 22.0 (IQR 15.0 to 25.0); CMS 29.5 (IQR 15.0 to 35.75); and DASH -30.0 (IQR -20.6 to -41.67) (all p < 0.001)) with the exception of one revised prosthesis. Conclusion. In conclusion, we found that 20 out of 24 implants stabilized within 12 months postoperatively. The significance of continuous migration in four implants is unclear and future research on the predictive value of early migration for future loosening in TSA is required. Clinical results revealed a clinically relevant improvement. Cite this article: Bone Joint J 2022;104-B(1):76–82

Aims. The aim of this study is to provide a detailed description of cases combining bridging patch repair with artificial ligament “internal brace” reinforcement to treat irreparable massive rotator cuff tears, and report the preliminary results. Methods. This is a retrospective review of patients with irreparable massive rotator cuff tears undergoing fascia lata autograft bridging repair with artificial ligament “internal brace” reinforcement technique between January 2017 and May 2018. Inclusion criteria were: patients treated arthroscopically for an incompletely reparable massive rotator cuff tear (dimension > 5 cm or two tendons fully torn), stage 0 to 4 supraspinatus fatty degeneration on MRI according to the Goutallier grading system, and an intact or reparable infraspinatus and/or subscapularis tendon of radiological classification Hamada 0 to 4. The surgical technique comprised two components: first, superior capsular reconstruction using an artificial ligament as an “internal brace” protective device for a fascia lata patch. The second was fascia lata autograft bridging repair for the torn supraspinatus. In all, 26 patients with a mean age 63.4 years (SD 6.2) were included. Results. All patients underwent more than two years of follow-up (mean 33.5 months (24 to 45)). All clinical scores were also improved at two-year follow-up (mean visual analogue scale 0.7 (SD 0.5) vs 6.1 (SD 1.2); p < 0.001; mean American Shoulder and Elbow Surgeons score 93.5 (SD 5.3) vs 42.5 (SD 10.8); p < 0.001; mean University of California, Los Angeles score, 31.7 (SD 3.7) vs 12.0 (SD 3.1); p < 0.001; and mean Constant-Murley score 88.7 (SD 3.5) vs 43.3 (SD 10.9); p < 0.001), and 24 of 26 fascia lata grafts were fully healed on MRI (92%). One patient had haematoma formation at the harvesting side of the fascia lata at two days postoperatively. Conclusion. The fascia lata autograft bridging repair combined with artificial ligament internal brace reinforcement technique achieved good functional outcomes, with a high rate of graft healing at two-year follow-up. Although the short-term results are promising, further studies with a greater number of patients would provide clearer results. Cite this article: Bone Joint J 2021;103-B(10):1619–1626

Aims. Ultrasound (US)-guided injections are widely used in patients with conditions of the shoulder in order to improve their accuracy. However, the clinical efficacy of US-guided injections compared with blind injections remains controversial. The aim of this study was to compare the accuracy and efficacy of US-guided compared with blind corticosteroid injections into the glenohumeral joint in patients with primary frozen shoulder (FS). Methods. Intra-articular corticosteroid injections were administered to 90 patients primary FS, who were randomly assigned to either an US-guided (n = 45) or a blind technique (n = 45), by a shoulder specialist. Immediately after injection, fluoroscopic images were obtained to assess the accuracy of the injection. The outcome was assessed using a visual analogue scale (VAS) for pain, the American Shoulder and Elbow Surgeons (ASES) score, the subjective shoulder value (SSV) and range of movement (ROM) for all patients at the time of presentation and at three, six, and 12 weeks after injection. Results. The accuracy of injection in the US and blind groups was 100% (45/45) and 71.1% (32/45), respectively; this difference was significant (p < 0.001). Both groups had significant improvements in VAS pain score, ASES score, SSV, forward flexion, abduction, external rotation, and internal rotation throughout follow-up until 12 weeks after injection (all p < 0.001). There were no significant differences between the VAS pain scores, the ASES score, the SSV and all ROMs between the two groups at the time points assessed (all p > 0.05). No injection-related adverse effects were noted in either group. Conclusion. We found no significant differences in pain and functional outcomes between the two groups, although an US-guided injection was associated with greater accuracy. Considering that it is both costly and time-consuming, an US-guided intra-articular injection of corticosteroid seems not always to be necessary in the treatment of FS as it gives similar outcomes as a blind injection. Cite this article: Bone Joint J 2021;103-B(2):353–359

Aims. This study aimed to determine the minimal detectable change (MDC), minimal clinically important difference (MCID), and substantial clinical benefit (SCB) under distribution- and anchor-based methods for the Mayo Elbow Performance Index (MEPI) and range of movement (ROM) after open elbow arthrolysis (OEA). We also assessed the proportion of patients who achieved MCID and SCB; and identified the factors associated with achieving MCID. Methods. A cohort of 265 patients treated by OEA were included. The MEPI and ROM were evaluated at baseline and at two-year follow-up. Distribution-based MDC was calculated with confidence intervals (CIs) reflecting 80% (MDC 80), 90% (MDC 90), and 95% (MDC 95) certainty, and MCID with changes from baseline to follow-up. Anchor-based MCID (anchored to somewhat satisfied) and SCB (very satisfied) were calculated using a five-level Likert satisfaction scale. Multivariate logistic regression of factors affecting MCID achievement was performed. Results. The MDC increased substantially based on selected CIs (MDC 80, MDC 90, and MDC 95), ranging from 5.0 to 7.6 points for the MEPI, and from 8.2° to 12.5° for ROM. The MCID of the MEPI were 8.3 points under distribution-based and 12.2 points under anchor-based methods; distribution- and anchor-based MCID of ROM were 14.1° and 25.0°. The SCB of the MEPI and ROM were 17.3 points and 43.4°, respectively. The proportion of the patients who attained anchor-based MCID for the MEPI and ROM were 74.0% and 94.7%, respectively; furthermore, 64.2% and 86.8% attained SCB. Non-dominant arm (p = 0.022), higher preoperative MEPI rating (p < 0.001), and postoperative visual analogue scale pain score (p < 0.001) were independent predictors of not achieving MCID for the MEPI, while atraumatic causes (p = 0.040) and higher preoperative ROM (p = 0.005) were independent risk factors for ROM. Conclusion. In patients undergoing OEA, the MCID for the increased MEPI is 12.2 points and 25° increased ROM. The SCB is 17.3 points and 43.3°, respectively. Future studies using the MEPI and ROM to assess OEA outcomes should report not only statistical significance but also clinical importance. Cite this article: Bone Joint J 2021;103-B(2):366–372

Aims. The purpose of this study was to determine whether there were long-term differences in outcomes of reverse shoulder arthroplasty (RSA) undertaken for acute proximal humeral fracture versus rotator cuff deficiency with a minimum follow-up of five years. Methods. This was a prospective cohort study comparing 67 patients with acute complex proximal humeral fracture and 64 patients with irreparable rotator cuff deficiency who underwent primary RSA. In the fracture group, there were 52 (77.6%) females and 15 (22.4%) males, with a mean age of 73.5 years (51 to 85), while in the arthropathy group, there were 43 (67.1%) females and 21 (32.9%) males, with a mean age of 70.6 years (50 to 84). Patients were assessed by the Constant score, University of California Los Angeles shoulder score (UCLA), short version of the Disability of the Arm Shoulder and Hand score (QuickDASH), and visual analogue scales (VAS) for pain and satisfaction. Radiological evaluation was also performed. Results. Mean follow-up was 8.4 years (5 to 11). There were no significant differences in mean absolute (p = 0.125) or adjusted (p = 0.569) Constant, UCLA (p = 0.088), QuickDASH (p = 0.135), VAS-pain (p = 0.062), or range of movement at the final follow-up. However, patient satisfaction was significantly lower in the fracture group (p = 0.002). The complication rate was 1.5% (one patient) versus 9.3% (six patients), and the revision rate was 1.5% (one patient) versus 7.8% (five patients) in the fracture and arthropathy groups, respectively. The ten-year arthroplasty survival was not significantly different (p = 0.221). Conclusion. RSA may be used not only for patients with irreparable rotator cuff deficiencies, but also for those with acute complex proximal humeral fractures. We found that RSA provided similar functional outcomes and a low revision rate for both indications at long-term. However, satisfaction is lower in patients with an acute fracture. Cite this article: Bone Joint J 2020;102-B(11):1555–1559

Aims. Existing literature indicates that inferiorly inclined glenoid baseplates following reverse total shoulder arthroplasty (RSA) produce better outcomes compared to superiorly inclined baseplates. We aim to compare clinical outcomes for RSAs with superiorly and neutrally/inferiorly inclined lateralized glenospheres. Methods. We retrospectively reviewed 154 consecutive patients undergoing RSA between July 2015 and July 2017 by one single-fellowship trained surgeon (AJ). Two raters (KAM and MVS) independently measured glenoid inclination in preoperative and minimum two year follow-up radiographs (anteroposterior/Grashey) using the RSA angle. Inclination was then compared to patient-reported outcomes, range of motion (ROM), and independently assessed degree of scapular notching and staging of heterotopic ossification at two year follow-up. Results. Median postoperative inclination for each group was found to be -3.6° (interquartile range (IQR) -2.1 to -6.9) and 6.0° (3.2° to 10.1°) for the neutrally/inferiorly and superiorly inclined cohorts, respectively. Preoperative inclination was highly associated with postoperative inclination (p = 0.004). When comparing superiorly and neutrally/inferiorly inclined glenospheres, there were no differences in heterotopic ossification (p = 0.606), scapular notching (p = 0.367), American Shoulder and Elbow Surgeons score (p = 0.419), Single Assessment Numeric Evaluation (p = 0.417), Visual Analogue Scale (VAS) pain score (p = 0.290), forward elevation (p = 0.161), external rotation (p = 0.537), or internal rotation (p = 0.656). Conclusion. Compared to neutral and inferior inclination, up to 6° ± 3° of superior glenoid baseplate inclination on a lateralized RSA design produces no differences in postoperative ROM or patient-reported outcomes, and produces similar levels of scapular notching and heterotopic ossification. Additionally, the degree of preoperative inclination represents an important factor in surgical decision-making as it is strongly associated with postoperative inclination. It is important to note that the findings of this study are only reflective of lateralized RSA prostheses. Cite this article: Bone Joint J 2021;103-B(2):360–365

Aims. Failure of healing is a well-known problem after repair of the rotator cuff. This study aimed to investigate if early repair of trauma-related full-thickness rotator cuff tears (FTRCTs) could prevent this failure. Patients and Methods. In this prospective trial, 62 consecutive patients (14 women (23%), 48 men (77%); median age 61 years (interquartile range (IQR) 54 to 65)) with trauma-related FTRCT underwent arthroscopic single-row repair within six weeks of trauma. Tendon integrity was assessed one year after surgery using the Sugaya score on MR images. Patients were followed up with Western Ontario Rotator Cuff (WORC) index, EuroQol visual analogue scale (EQ VAS), and the Constant–Murley score (CS) two years after repair. Results. A total of 57 patients (92%) had MR images available at one year; 59 patients (95%) had CS (one year), WORC (two years), and EQ VAS scores (two years). Intact repair was found on MRI in 36 patients (63%); 13 patients (23%) displayed healing failure of at least one repaired tendon and eight patients (14%) displayed total healing failure. Median WORC index and relative CS improved from 30.8 points (IQR 20.1 to 38.6) at baseline to 85.0 points (IQR 60.6 to 95.7) at two years and 26.5 points (IQR 21.2 to 37.4) to 83.2 points (IQR 71.9 to 97.5) at one year, respectively. The relative CS at one year was significantly better among those with intact repairs compared with those with healing failure (91.6 vs 78.1 points; p = 0.031). Conclusion. Although early repair of trauma-related FTRCT improved patient relevant outcomes over two years for the entire cohort, only two out of three repaired rotator cuffs displayed intact structural integrity on MRI after one year. Consequently, early repair did not seem to prevent healing failure after trauma-related FTRCT. Cite this article: Bone Joint J 2019;101-B:603–609

Aims

This study aimed to assess the impact of using the metal-augmented glenoid baseplate (AGB) on improving clinical and radiological outcomes, as well as reducing complications, in patients with superior glenoid wear undergoing reverse shoulder arthroplasty (RSA).

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Favourable short-term outcomes have been reported following latissimus dorsi tendon transfer for patients with an irreparable subscapularis (SSC) tendon tear. The aim of this study was to investigate the long-term outcomes of this transfer in these patients.

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The aim of this study was to longitudinally compare the clinical and radiological outcomes of anatomical total shoulder arthroplasty (aTSA) up to long-term follow-up, when using cemented keel, cemented peg, and hybrid cage peg glenoid components and the same humeral system.

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The aim of this study was to compare the clinical and radiological outcomes of reverse shoulder arthroplasty (RSA) using small and standard baseplates in Asian patients, and to investigate the impact of a mismatch in the sizes of the glenoid and the baseplate on the outcomes.

Aims. The crucial role of the radial head in the stability of the elbow in terrible triad injury is acknowledged. This retrospective study aims to compare the results of resection of a severely comminuted radial head with or without prosthetic arthroplasty as part of the reconstruction for this injury. Patients and Methods. The outcome of radial head resection was compared with prosthetic arthroplasty in 29 and 15 patients with terrible triad injuries, respectively. There were ten female patients (34.5%) in the resection group and six female patients (40%) in the prosthesis group. The mean age was 40.7 years (. sd. 13.6) in the resection group and 36 years (. sd. 9.4) in the prosthesis group. The mean follow-up of the patients was 24.4 months (. sd. 12) in the resection group and 45.8 months (. sd. 6.8) in the prosthesis group. Outcome measures included visual analogue scale (VAS) for pain, Mayo Elbow Performance Score (MEPS), Disabilities of Arm, Shoulder and Hand (DASH) Score, and range of movement. Postoperative radiological complications were also recorded. Results. The mean ranges of extension, flexion, supination, and pronation were not significantly different between the two study groups (p = 0.75, p = 0.65, p = 0.82, and p = 0.68, respectively). The mean VAS score, DASH score, and MEPS of the two groups were also not statistically significantly different (p = 0.93, p = 0.19, and p = 0.32, respectively). At the final visit, the elbow was stable in all patients. No patient was found to have developed an Essex–Lopresti injury. Osteoarthritis grade I and II was observed in five and three patients of the resection group, respectively, and four and one patients of the arthroplasty group, respectively. Conclusion. The outcome of patients undergoing treatment for terrible triad injuries is similar whether the patient’s radial head was excised or replaced. Cite this article: Bone Joint J 2018;100-B:1499–505

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This study compared patients who underwent arthroscopic repair of large to massive rotator cuff tears (LMRCTs) with isolated incomplete repair of the tear and patients with incomplete repair with biceps tendon augmentation. We aimed to evaluate the additional benefit on clinical outcomes and the capacity to lower the re-tear rate.

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The outcomes following nonoperative management of minimally displaced greater tuberosity (GT) fractures, and the factors which influence patient experience, remain poorly defined. We assessed the early patient-derived outcomes following these injuries and examined the effect of a range of demographic- and injury-related variables on these outcomes.

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Rates of reverse total shoulder arthroplasty (rTSA) continue to grow. Glenoid bone loss and deformity remains a technical challenge to the surgeon and may reduce improvements in patients’ outcomes. However, there is no consensus as to the optimal surgical technique to best reconstruct these patients’ anatomy. This review aims to compare the outcomes of glenoid bone grafting versus augmented glenoid prostheses in the management of glenoid bone loss in primary reverse total shoulder arthroplasty.

Rotator cuff pathology is the main cause of shoulder pain and dysfunction in older adults. When a rotator cuff tear involves the subscapularis tendon, the symptoms are usually more severe and the prognosis after surgery must be guarded. Isolated subscapularis tears represent 18% of all rotator cuff tears and arthroscopic repair is a good alternative primary treatment. However, when the tendon is deemed irreparable, tendon transfers are the only option for younger or high-functioning patients. The aim of this review is to describe the indications, biomechanical principles, and outcomes which have been reported for tendon transfers, which are available for the treatment of irreparable subscapularis tears.

The best tendon to be transferred remains controversial. Pectoralis major transfer was described more than 30 years ago to treat patients with failed surgery for instability of the shoulder. It has subsequently been used extensively to manage irreparable subscapularis tendon tears in many clinical settings. Although pectoralis major reproduces the position and orientation of the subscapularis in the coronal plane, its position in the axial plane – anterior to the rib cage – is clearly different and does not allow it to function as an ideal transfer. Consistent relief of pain and moderate recovery of strength and function have been reported following the use of this transfer. In an attempt to improve on these results, latissimus dorsi tendon transfer was proposed as an alternative and the technique has evolved from an open to an arthroscopic procedure. Satisfactory relief of pain and improvements in functional shoulder scores have recently been reported following its use. Both pectoralis minor and upper trapezius transfers have also been used in these patients, but the outcomes that have been reported do not support their widespread use.

Cite this article: Bone Joint J 2024;106-B(9):970–977.

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We sought to compare functional outcomes and survival between non-smokers, former smokers, and current smokers who underwent anatomical total shoulder arthroplasty (aTSA) in a large cohort of patients.