Background: No regenerative approach has thus far been shown to be effective in skeletal muscle injuries, despite their high frequency and associated functional deficits. We sought to address surgical trauma‐related muscle injuries using local intraoperative application of allogeneic placenta‐derived, mesenchymal‐like adherent cells (PLX‐PAD), using hip arthroplasty as a standardized injury model, because of the high regenerative and immunomodulatory potency of this cell type.Methods: Our pilot phase I/IIa study was prospective, randomized, double blind, and placebo‐controlled. Twenty patients undergoing hip arthroplasty via a direct lateral approach received an injection of 3.0 × 10⁸ (300 M, n = 6) or 1.5 × 10⁸ (150 M, n = 7) PLX‐PAD or a placebo (n = 7) into the injured gluteus medius muscles.Results: We did not observe any relevant PLX‐PAD‐related adverse events at the 2‐year follow‐up. Improved gluteus medius strength was noted as early as Week 6 in the treatment‐groups. Surprisingly, until Week 26, the low‐dose group outperformed the high‐dose group and reached significantly improved strength compared with placebo [150 M vs. placebo: P = 0.007 (baseline adjusted; 95% confidence interval 7.6, 43.9); preoperative baseline values mean ± SE: placebo: 24.4 ± 6.7 Nm, 150 M: 27.3 ± 5.6 Nm], mirrored by an increase in muscle volume [150 M vs. placebo: P = 0.004 (baseline adjusted; 95% confidence interval 6.0, 30.0); preoperative baseline values GM volume: placebo: 211.9 ± 15.3 cm³, 150 M: 237.4 ± 27.2 cm³]. Histology indicated accelerated healing after cell therapy. Biomarker studies revealed that low‐dose treatment reduced the surgery‐related immunological stress reaction more than high‐dose treatment (exemplarily: CD16+ NK cells: Day 1 P = 0.06 vs. placebo, P = 0.07 vs. 150 M; CD4+ T‐cells: Day 1 P = 0.04 vs. placebo, P = 0.08 vs. 150 M). Signs of late‐onset immune reactivity after high‐dose treatment corresponded to reduced functional improvement.Conclusions: Allogeneic PLX‐PAD therapy improved strength and volume of injured skeletal muscle with a reasonable safety profile. Outcomes could be positively correlated with the modulation of early postoperative stress‐related immunological reactions.

Fast-track surgery is becoming increasingly popular, whereas the monitoring of postoperative rehabilitation remains a matter of considerable debate. The aim of this study was to validate a newly developed wearable system intended to monitor knee function and mobility. A sensor system with a nine-degree-of-freedom (DOF) inertial measurement unit (IMU) was developed. Thirteen healthy volunteers performed five 10-meter walking trials with simultaneous sensor and motion capture data collection. The obtained kinematic waveforms were analysed using root mean square error (RMSE) and correlation coefficient (CC) calculations. The Bland–Altman method was used for the agreement of discrete parameters consisting of peak knee angles between systems. To test the reliability, 10 other subjects with sensors walked a track of 10 metres on two consecutive days. The Pearson CC was excellent for the walking data set between both systems (r = 0.96) and very good (r = 0.95) within the sensor system. The RMSE during walking was 5.17° between systems and 6.82° within sensor measurements. No significant differences were detected between the mean values observed, except for the extension angle during the stance phase (E1). Similar results were obtained for the repeatability test. Intra-class correlation coefficients (ICCs) between systems were excellent for the flexion angle during the swing phase (F1); good for the flexion angle during the stance phase (F2) and the re-extension angle, which was calculated by subtracting the extension angle at swing phase (E2) from F2; and moderate for the extension angle during the stance phase (E1), E2 and the range of motion (ROM). ICCs within the sensor measurements were good for the ROM, F2 and re-extension, and moderate for F1, E1 and E2. The study shows that the novel sensor system can record sagittal knee kinematics during walking in healthy subjects comparable to those of a motion capture system.

Background: The efficacy of external ankle braces to protect against sudden inversion sprain has yet to be determined while taking into account the possible placebo effect of brace application. Purpose: To assess the protective effect of an external ankle brace on ankle kinematics during simulated inversion sprain and single-legged drop landings among individuals with a history of unilateral lateral ankle sprain. Hypothesis: The primary hypothesis was that active and placebo external braces would reduce inversion angle during simulated inversion sprain. Study Design: Controlled laboratory study. Methods: Sixteen participants with ankle instability and previous sprain performed single-legged drop landings and sudden inversion tilt perturbations. Kinematics of the affected limb were assessed in 3 conditions (active bracing, passive placebo bracing, and unbraced) across 2 measurement days. Participators and investigators were blinded to the brace type tested. The effect of bracing on kinematics was assessed with repeated measures analysis of variance with statistical parametric mapping, with post hoc tests performed for significant interactions. Results: Only active bracing reduced inversion angles during a sudden ankle inversion when compared with the unbraced condition. This reduction was apparent between 65 and 140 milliseconds after the initial fall. No significant differences in inversion angle were found between the passive placebo brace and unbraced conditions during sudden ankle inversion. Furthermore, no significant differences were found among all tested conditions in the sagittal plane kinematics at the knee and ankle. Conclusion: During an inversion sprain, only the actively protecting ankle brace limited inversion angles among participants. These results do not indicate a placebo effect of external bracing for patients with ankle instability and a history of unilateral ankle sprain. Furthermore, sagittal plane knee kinematics appear to remain unaffected by bracing during single-legged landing, owing to the limited effects of bracing on sagittal ankle kinematics. These results highlight the role of brace design on biomechanical function during sports-related and injury-prone movements. Clinical Relevance: Athletes prone to reinjury after lateral ankle sprain may benefit from brace designs that allow for full sagittal range of motion but restrict only frontal plane motion.