The aim of the HIPGEN consortium is to develop the first cell therapy product for hip fracture patients using PLacental-eXpanded (PLX-PAD) stromal cells. HIPGEN is a multicentre, multinational, randomized, double-blind, placebo-controlled trial. A total of 240 patients aged 60 to 90 years with low-energy femoral neck fractures (FNF) will be allocated to two arms and receive an intramuscular injection of either 150 × 106 PLX-PAD cells or placebo into the medial gluteal muscle after direct lateral implantation of total or hemi hip arthroplasty. Patients will be followed for two years. The primary endpoint is the Short Physical Performance Battery (SPPB) at week 26. Secondary and exploratory endpoints include morphological parameters (lean body mass), functional parameters (abduction and handgrip strength, symmetry in gait, weightbearing), all-cause mortality rate and patient-reported outcome measures (Lower Limb Measure, EuroQol five-dimension questionnaire). Immunological biomarker and in vitro studies will be performed to analyze the PLX-PAD mechanism of action. A sample size of 240 subjects was calculated providing 88% power for the detection of a 1 SPPB point treatment effect for a two-sided test with an α level of 5%.Aims
Methods
The objective of this systematic review was to describe trapeziectomy outcomes and complications in the context of osteoarthritis of the base of the thumb after a five-year minimum follow-up. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used to guide study design, and 267 full-text articles were assessed for eligibility. After exclusion criteria application, 22 studies were included, involving 728 patients and 823 trapeziectomies. Outcomes included pre- and postoperative clinical and radiological characteristics. Complications and revisions were recorded.Aims
Methods
