Efficacy and Safety of Intra-Articular Cross-Linked Sodium Hyaluronate for the Treatment of Knee Osteoarthritis: A Prospective, Active-Controlled, Randomized, Parallel-Group, Double-Blind, Multicenter Study.

The safety and efficacy of Hyruan ONE (test product), an intra-articular cross-linked sodium hyaluronate injection, to treat mild-to-moderate knee osteoarthritis was compared with that of Durolane (comparator) in a prospective, active-controlled, parallel-group, double-blind (masked-observed), multicenter non-inferiority study. European patients (n = 284) were randomized 1:1 (test product:comparator) and received one injection of cross-linked hyaluronic acid (60 mg/3 mL). In total, 280 patients completed the study. The primary endpoint of mean change in Western Ontario and McMaster University (WOMAC)-Likert Pain sub-scores from baseline at week 13 revealed changes of -5.59 and -5.54 for the test and comparator groups, respectively, demonstrating non-inferiority of the test product (difference, -0.05 [95% confidence interval, -0.838 to 0.729]). Secondary endpoint results, which included changes in WOMAC-Likert Pain sub-score from baseline to 26 weeks post-injection and changes in WOMAC-Likert Total score and Physical Function and Stiffness sub-scores, changes in patients' and investigators' global assessments, use of rescue medication, and responder rates at 13 and 26 weeks post-injection were similar between the groups. Incidence of adverse events was also similar. In both groups, most treatment-emergent adverse events were mild/moderate. Hyruan ONE was non-inferior to the comparator at 13 weeks post-injection in European patients with mild-to-moderate knee osteoarthritis.

The Efficacy and Safety of Abaloparatide-SC in Men With Osteoporosis: A Randomized Clinical Trial.

Abaloparatide significantly increased bone mineral density (BMD) in women with postmenopausal osteoporosis and decreased risk of vertebral, nonvertebral, and clinical fractures compared with placebo. The Abaloparatide for the Treatment of Men with Osteoporosis (ATOM; NCT03512262) study evaluated the efficacy and safety of abaloparatide compared with placebo in men. Eligible men aged 40 to 85 years with osteoporosis were randomized 2:1 to daily subcutaneous injections of abaloparatide 80 µg or placebo for 12 months. The primary endpoint was change from baseline in lumbar spine BMD. Key secondary endpoints included BMD change from baseline at the total hip and femoral neck. A total of 228 men were randomized (abaloparatide, n = 149; placebo, n = 79). Baseline characteristics were similar across treatment groups (mean age, 68.3 years; mean lumbar spine BMD T-score, -2.1). At 12 months, BMD gains were greater with abaloparatide compared with placebo at the lumbar spine (least squares mean percentage change [standard error]: 8.48 [0.54] versus 1.17 [0.72]), total hip (2.14 [0.27] versus 0.01 [0.35]), and femoral neck (2.98 [0.34] versus 0.15 [0.45]) (all p < 0.0001). The most common (≥5%) treatment-emergent adverse events were injection site reaction, dizziness, nasopharyngitis, arthralgia, bronchitis, hypertension, and headache. During 12 months of abaloparatide treatment, men with osteoporosis exhibited rapid and significant improvements in BMD with a safety profile consistent with previous studies. These results suggest abaloparatide can be considered as an effective anabolic treatment option for men with osteoporosis. © 2022 Radius Health Inc and The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).

Knee Osteoarthritis Pain Management with an Innovative High and Low Molecular Weight Hyaluronic Acid Formulation (HA-HL): A Randomized Clinical Trial.

INTRODUCTION: The objective of this study was to compare a single intra-articular injection of an innovative high and low molecular weight hyaluronic acid formulation (HA-HL) versus placebo in treating moderate-to-severe symptomatic knee osteoarthritis. METHODS: Subjects with primary osteoarthritis knee pain (Kellgren and Lawrence grade 2-3) were randomly assigned to intra-articular HA-HL or placebo in a prospective, double-blind, 24-week study. The primary outcome variable was change from screening to week 24 of a Visual Analogue Scale (VAS) pain score. Secondary outcomes included Lequesne's algofunctional index, EuroQol 5-Dimension Questionnaire, 5-level version (EQ-5D-5L), Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) response and rescue medication usage. RESULTS: In a total of 692 randomized patients, a rapid decrease was observed in mean VAS pain score from baseline to week 1 (26 ± 24 mm in the HA-HL group vs. 23 ± 23 mm in the placebo group); pain intensity continued to decrease during 24 weeks of follow-up, reaching a mean change from baseline of 35 ± 28 mm vs. 32 ± 27 mm at week 24. Mixed model analysis demonstrated statistically significant differences between groups in favor of the HA-HL group at weeks 1, 6, 12, and 24. HA-HL was also more effective than placebo in improving Lequesne's algofunctional index, OMERACT-OARSI response, and health-related quality of life. The use of rescue medication (paracetamol 500 mg tablets; ≤ 6 per day) was lower in the HA-HL group. Both treatments were similarly well tolerated. CONCLUSIONS: A single intra-articular injection of an innovative high and low molecular weight hyaluronic acid formulation (HA-HL) is effective in providing fast, sustained, and clinically relevant reductions in pain, functional limitation, and health-related quality of life that were apparent at 1 week after the intra-articular injection and maintained throughout the 24-week follow-up in subjects with painful knee osteoarthritis, with a good safety profile. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03200288.

Evaluation of adductor myotomy versus adductor transfer to ischiadic tuber in the treatment of spastic hip in cerebral palsy.

BACKGROUND: The muscle imbalance associated with the spastic type of infantile cerebral palsy may result in subluxations or dislocations of the hip. The aim of the study was to compare the clinical and radiological results of myotomy of the hip adductor muscles versus adductor transfer to the ischiadic tuber in the prevention of hip subluxation and dislocation in infantile cerebral palsy. MATERIAL AND METHODS: The study involved 36 ambulant children with spastic diparetic CP treated at our Department in the years 1987-2002. Group I consisted of 21 children (41 hip joints) who underwent myotomy of the adductor longus, adductor brevis and gracilis muscles. Mean age at the time of surgery was 10 years (3 to 17 years). Group II consisted of 15 children (28 hip joints) who underwent transfer of the tendons of the adductor muscles to the ischiadic tuber. Mean age at the time of surgery in this group was 8 years (3 to 16 years). The mean duration of hospital stay was 6 days in Group I and 9 days in Group II. Rehabilitation was carried out for an average of 3 months in Group I and 4 months in Group II. RESULTS: The follow-up examination showed improvement in the hip range of motion in both groups and no radiographic differences. CONCLUSIONS: Adductor myotomy is superior to adductor transfer because of easier surgical technique, shorter duration of hospital stay and no need to immobilize the hip.

[Breakage of the prosthesis steam as a rare complication of total hip replacement]. / Zlamanie trzpienia endoprotezy jako rzadkie powiklanie alloplastyki stawu biodrowego--opis dwóch przypadków.

The aim of the study was to present a rear complication of total hip replacement, with is a breakage of prosthesis steam and the following treatment. Two cases of Mittelmeier steam breakage were presented--10 and 15 years after operation. In both cases the indication for primary surgery was dysplastic coxarthrosis. Both patients underwent revision hip arthroplasty with prosthesis steam reimplantation. Follow-up performed every year is a well accepted way of early detection of late complications. Hip revisions arthroplasties should be performed in a specialized hospitals having adequate implants and instrumentation. For revision of broken steam of prosthesis the transfemoral approach is the method of choice together with long, revision femoral implants having its fit in femoral shaft.