BackgroundAccording to EULAR and OARSI guidelines, evidence is inconclusive for the symptomatic benefits of an unloader knee brace in medial knee osteoarthritis (OA).ObjectivesThe objective of this multicenter randomised controlled trial (RCT) (ClinicalTrials Id. NCT02765685) was to compare the efficacy and safety of the ODRA brace, a distraction-rotation custom-made knee brace versus usual care over one year in medial knee OA.MethodsPatients with symptomatic medial knee OA (VAS pain scores at rest >40/100 for the medial compartment) and Kellgren-Lawrence (KL) grade II-IV were randomised in two groups: brace group (ODRA +usual care) vs usual care alone (UCA). Patients were followed up every two months for one year. Usual care consisted of all the pharmacological and non-pharmacological treatments used for the management of knee OA. The primary end-point was the difference of VAS-pain between M0 and M12. Secondary end-points included patient global assessment of disease severity (PGA) on VAS,% of patients reaching the PASS (VAS-pain <30/100) and MCII (delta VAS-pain >20/100) thresholds at M12, KOOS scores, OA-specific quality of life questionnaire (OAKHQOL), as well as drug intake. Safety and compliance were evaluated by recording side effects and average knee brace duration of wear, respectively.ResultsOverall 120 patients (57% women) from 7 centres were included. Their characteristics were the following: mean age 63.6±11.4 years; BMI 29.6±5.5 kg/m2; OA duration 5.8±6 years; 52% KL III; 21% KL IV. The VAS pain decrease was statistically higher in the ODRA group (from 61.9±17.4 (M0) to 38.8±25.3 (M12) than in the UCA group (54.9±18.2 to 45.5±23.8) in the intent to treat bivariate and multivariate analyses (delta VAS-pain: 13.1±4.9, p<0.01). At M12, ODRA patients experienced a significant higher improvement than the UCA patients for PGA, all KOOS domains and for 3 of 5 domains of OAKHQOL (Pain, Physical activities, Mental health). Patients reaching PASS threshold at M12 were 42% in ODRA group vs 27% in UCA group (OR=3.04; 95% CI: 1.11 to 8.30; p<0.05) and were 46% vs 28% for MCII respectively (OR=2.65, 95% CI: 1.01 to 6.96; p<0.05). The overall analgesic use decreased more frequently in the ODRA group at M12 than in the UCA group (32.7% vs 15.4%, p<0.05) except for NSAIDs, HA or steroid injections. The compliance was good: the brace was worn for a median [IQR] duration of 5.7 [4.0–7.0] hours a day between M0 and M6 and 5.3 [3.7–6.3] hours a day between M6 and M12. Non-serious side effects were more common in the ODRA group (p<0.05) which justified the definitive withdrawal of the brace in 8 ODRA patients (13%), mainly for cutaneous side effects.ConclusionsIn this RCT, the use of the ODRA brace in addition to usual care was shown to be superior to usual care alone in reducing symptoms and improving quality of life of patients suffering from medial knee OA, with good compliance.Disclosure of InterestNone declared
Background Current management of foot pain requires foot orthoses (FOs) with various design features (eg, wedging, height) and specific mechanical properties (eg, hardness, volume). Development of additive manufacturing (three-dimensional [3-D] printing) raises the question of applying its technology to FO manufacturing. Recent studies have demonstrated the physical benefits of FO parts with specific mechanical properties, but none have investigated the relationship between honeycomb architecture (HcA) infilling density and Shore A hardness of thermoplastic polyurethane (TPU) used to make FOs, which is the aim of this study. Methods Sixteen different FO samples were made with a 3-D printer using TPU (97 Shore A), with HcA infilling density ranging from 10 to 40. The mean of two Shore A hardness measurements was used in regression analysis. Results Interdurometer reproducibility was excellent (intraclass correlation coefficient, 0.91; 95% confidence interval [CI], 0.64–0.98; P < .001) and interprinter reproducibility was excellent/good (intraclass correlation coefficient, 0.84; 95% CI, 0.43–0.96; P < .001). Linear regression showed a positive significant relationship between Shore A hardness and HcA infilling density (R2 = 0.955; P < .001). Concordance between evaluator and durometer was 86.7%. Conclusions This study revealed a strong relationship between Shore A hardness and HcA infilling density of TPU parts produced by 3-D printing and highlighted excellent concordance. These results are clinically relevant because 3-D printing can cover Shore A hardness values ranging from 40 to 70, representing most FO production needs. These results could provide important data for 3-D manufacturing of FOs to match the population needs.
BackgroundComputed tomography (CT) is considered the imaging benchmark for the assessment of certain structural lesions in the sacroiliac joints (SIJ) of patients with axial spondyloarthritis (axSpA). Availability of low dose radiation techniques may lead to more widespread use, potentially as a structural endpoint in clinical trials research.ObjectivesWe aimed to validate a new CT-based scoring method, the CT Sacroiliac Structural Score (CT-SSS), for assessing structural lesions in the SIJ.MethodsCT scans of the SIJ from 44 patients (26 females, mean age 49.4 years, mean symptom duration 9.1 years) were reconstructed in the semicoronal plane parallel to the superior border of the sacrum and scoring of lesions was confined to this plane. Structural lesions were scored in consecutive slices in SIJ quadrants (erosion, sclerosis) or SIJ halves (ankylosis) on a dichotomous basis (present/absent) using the same anatomical principles as developed for the SPARCC MRI SIJ inflammation and structural scores. The most anterior slice is defined as visible joint ≥1cm vertical height and when <3 cm is defined as having only upper iliac and sacral quadrants. A visible joint ≥3cm vertical height is defined as having 4 quadrants. At the posterior aspect of the SIJ, there is a natural separation of iliac and sacral cortical bone by structures in the ligamentary portion. Scoring is terminated when <1cm of iliac and sacral bone is appositional. Two readers independently scored CT scans without a prior calibration exercise and using direct online data entry onto a schematic of the SIJ. Reliability was assessed by kappa statistics, intra-class correlation coefficient (ICC), and Bland-Altman limits of agreement.ResultsScoring was feasible (5–10 minutes per scan) and both ankylosis (ICC=0.95) and erosion (ICC=0.81) were reliably scored (Table). Sclerosis was less reliably scored (ICC=0.39). Presence/absence of ankylosis was reliably detected irrespective of whether this was based on a single slice (κ=0.77) or 3 consecutive slices (κ=0.81). Reliable detection was lower for erosion (κ=0.50 for 1 or 3 slices) and sclerosis (κ=0.44 and 0.48 for 1 and 3 slices, respectively). Bland-Altman graphs illustrate reliability across the range of scores for ankylosis and erosion.Table 1.Descriptive and Reliability data for CT-SSS scoreMean (SD) scoreMedian (IQR) scoreICC95% L of A R1R2R1R2 Erosion4.4 (9.7)6.5 (11.5)0 (25.5)0 (21)0.95-10.7, 13.5Ankylosis7.5 (14.1)6 (13.6)0 (12)0 (12)0.81-16.2, 12.2Sclerosis6.6 (14.4)7.4 (18.2)0 (20)0 (24.5)0.39-34.5, 33.0IQR interquartile range L of A Limits of Agreement.ConclusionsThe CT-SSS method is feasible and reliable for scoring ankylosis and erosion with minimal calibration. Sclerosis requires further standardization and calibration.Disclosure of InterestNone declared
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