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Background: The Minimal Important Difference (MID) and Smallest Detectable Change (SDC) are methods used to identify the smallest changes in Patient-Reported Outcome Measures (PROMs) that are of relevance to the patients. Data on these parameters is, however, limited for elbow conditions including traumatic injuries. The aim of this study was, therefore, to estimate the MID and SDC for three commonly used PROMs after elbow trauma; the Oxford Elbow Score (OES), Quick Disabilities of the Arm Shoulder and Hand (QuickDASH) and Single Assessment Numeric Evaluation (SANE). Methods: One hundred patients, 67 females, aged ≥18 years (mean age 52.4 years (standard deviation, 18.2)), who had sustained a fracture, tendon rupture or dislocation affecting the elbow, completed the OES, QuickDASH, and SANE 3-5 months after injury (T1) and again after a minimum of 3 weeks (T2). A transition item with a 7-level scale, enquiring about the situation with the elbow, was also completed at T1 and T2. The difference in scores between T1 and T2 was calculated (change scores). The MID was assessed using the mean change method; a response of "slightly better" or "slightly worse" was defined as being a clinically significant change. The SDC was estimated by calculating the standard error of measurement based on 2 administrations (1- to 3-week interval) of PROMs in a separate group of patients who had sustained an elbow injury 1- 2 years previously. Results: The most common diagnosis was fracture of the proximal radius (n = 33). Eighteen patients responded slightly better and 5 slightly worse on the transition item and had mean change scores of 7.9 (9.3) for the OES and -7.4 (11.4) for the QuickDASH. Assessment of SDC was based on 56 patients having sustained an elbow injury between September 2019 and October 2020. The SDC was: 12.1 for the OES, 11.4 for the QuickDASH, and 1.94 for the SANE. Conclusion: Change scores need to exceed 12.1 points for the OES, 11.4 points for the QuickDASH, and 1.94 points for the SANE in order to measure change with clinical relevance and not due to measurement errors.
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BACKGROUND: Semiconstrained total elbow arthroplasty (TEA) is an established treatment for elderly patients with distal humeral fractures not amenable to stable internal fixation (unreconstructable). In recent years, there has been increasing interest in elbow hemiarthroplasty (EHA), a treatment option which does not entail restrictions on weight-bearing as opposed to TEA. These 2 treatments have not been compared in a randomized controlled trial (RCT). The aim of this study was to compare the functional outcome of EHA and TEA for the treatment of unreconstructable distal humeral fractures in elderly patients. MATERIAL AND METHODS: This was a multicenter randomized controlled trial (RCT). Patients were included between January 2011 and November 2019 at one of 3 participating hospitals. The inclusion criteria were an unreconstructable distal humeral fracture, age ≥60 years and independent living. The final follow-up took place after ≥2 years. The primary outcome measure was the Disabilities of the Arm, Shoulder, and Hand (DASH) score. Secondary outcome measures were the Mayo Elbow Performance Score (MEPS), the EQ-5D index, range of motion (flexion, extension, pronation, and supination) and grip strength. RESULTS: Forty patients were randomized to TEA (n = 20) and EHA (n = 20). Five patients died before completing the final follow-up, leaving 18 EHA and 17 TEA patients for analysis. There were 31 women. The mean age was 74.0 (SD, 8.5) years in the EHA group and 76.9 (SD, 7.6) in the TEA group (P = .30). The mean DASH score was 21.6 points in the EHA group and 27.2 in the TEA group (P = .39), a difference of -5.6 points (95% CI: -18.6 to 7.5). There were no differences between treatment with EHA and TEA for the mean values of the MEPS (85.0 vs. 88.2, P = .59), EQ-5D index (0.92 vs. 0.86, P = .13), extension (29° vs. 29°, P = .98), flexion (126° vs. 136°, P = .05), arc of flexion-extension (97° vs. 107°, P = .25), supination (81° vs. 75°, P = .13), pronation (78° vs. 74°, P = .16) or grip strength (17.5 kg vs. 17.2 kg, P = .89). There were 6 adverse events in each treatment group. CONCLUSION: In this RCT, both elbow hemiarthroplasty (EHA) and total elbow arthroplasty (TEA) resulted in a good and similar functional outcome for unreconstructable distal humeral fractures in elderly patients at a minimum of 2 years of follow-up.
Assuntos
Articulação do Cotovelo , Hemiartroplastia , Fraturas Distais do Úmero , Fraturas do Úmero , Idoso , Feminino , Humanos , Cotovelo/cirurgia , Hemiartroplastia/métodos , Resultado do Tratamento , Articulação do Cotovelo/cirurgia , Fixação Interna de Fraturas/métodos , Amplitude de Movimento Articular , Estudos RetrospectivosRESUMO
Background: The Oxford Elbow Score (OES) is a well-validated, elbow-specific, patient-reported outcome measure (PROM), originally assigned a 4-week recall period. For PROMs, short recall periods could have some advantages, such as optimizing validity by minimizing the negative effects of inaccurate recollection and temporal trends (increase or decrease) in symptoms over the course of the recall period. Temporal trends in elbow function can, for example, be expected to occur over 4 weeks in patients recovering from an injury or surgery. The purpose of this study was to evaluate the measurement properties of the OES using a shortened, 7-day, recall period (OES-7d). Methods: The inclusion criteria were fracture, tendon rupture or dislocation affecting the elbow, and age ≥18 years. Patients with Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores of ≥10 points preinjury (pre-existing upper extremity condition) or concurrent upper extremity injuries were excluded. Patients completed the OES-7d, QuickDASH, and Single Assessment Numeric Evaluation-Function for the last 7 days preinjury (T1), the first 7 days postinjury (T2) and a 7-day period 3-5 months postinjury (T3). Correlations were assessed with Spearman's rho. Analyses of construct validity (correlation between scores) and internal consistency (Cronbach's alpha) were based on T3 data. Responsiveness was assessed by correlating changes in scores (change scores) between time points. Intra-rater reliability was assessed by calculating intraclass correlation coefficients based on 2 administrations (1- to 3-week interval) of PROMs in a separate group of patients who had sustained an elbow injury 1-2 years previously. Results: Seventy-five patients (45 women) were included between May 2020 and July 2021. Their mean age was 51.7 years. At T3, Spearman's rho was -0.91 for the correlation between OES total and QuickDASH scores and 0.76 for the correlation between OES total scores and Single Assessment Numeric Evaluation-Function values (construct validity). Spearman's rho for correlation between OES total and QuickDASH change scores from T2 to T3 (T3 minus T2) was -0.85 (responsiveness for improvement) and -0.88 for change scores from T1 to T2 (T2 minus T1, responsiveness for deterioration). For the OES domains, Cronbach's alpha was 0.83 for elbow function, 0.91 for pain and 0.90 for social-psychological domains. The intraclass correlation coefficient for the OES total score was 0.96. Conclusion: The OES demonstrated good measurement properties when used with a 7-day recall period (OES-7d). These results further establish the OES as a well-validated, elbow-specific PROM and support using a 7-day recall period.
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BACKGROUND: The most appropriate treatment for displaced multiple-fragment proximal humeral fractures in elderly patients is currently unclear. Reverse total shoulder arthroplasty (rTSA) is a promising treatment option that is being used increasingly. The purpose of this study was to compare the outcome of rTSA vs. hemiarthroplasty (HA) for the treatment of displaced 3- and 4-part fractures in elderly patients. METHODS: This was a multicenter randomized controlled trial. We included patients aged ≥ 70 years with displaced 3- or 4-part proximal humeral fractures between September 2013 and May 2016. The minimum follow-up period was 2 years, with outcome measures including the Constant score (primary outcome), Western Ontario Osteoarthritis of the Shoulder index, EQ-5D (EuroQol 5 Dimensions) index, and range of motion, as well as pain and shoulder satisfaction assessed on a visual analog scale. RESULTS: We randomized 99 patients to rTSA (48 patients) or HA (51 patients). Fifteen patients were lost to follow-up, leaving 41 rTSA and 43 HA patients for analysis. The mean age was 79.5 years, and there were 76 women (90%). The rTSA group had a mean Constant score of 58.7 points compared with 47.7 points in the HA group, with a mean difference of 11.1 points (95% CI, 3.0-18.9 points; P = .007). Compared with HA patients, rTSA patients had greater mean satisfaction with the shoulder (79 mm vs. 63 mm, P = .011), flexion (125° vs. 90°, P < .001), and abduction (112° vs. 83°, P < .001), but there was no difference in Western Ontario Osteoarthritis of the Shoulder index, pain, or EQ-5D index scores. We identified 3 and 4 adverse events in the rTSA and HA groups, respectively. Among patients aged ≥ 80 years (n = 38), there was no difference between rTSA treatment and HA treatment in pain (17 mm vs. 9 mm, P = .17) or shoulder satisfaction (77 mm vs. 74 mm, P = .73). CONCLUSION: We found that rTSA provides better shoulder function than HA as measured with the Constant score, further emphasized by rTSA patients being more satisfied with their shoulder function. The difference appears to be mainly a result of better range of motion (abduction and flexion) in the rTSA group. The results also indicate that patients aged ≥ 80 years benefit less from rTSA than patients aged 70-79 years.