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
Intact abductors of the hip play a crucial role
in preventing limping and are known to be damaged through the direct lateral
approach. The extent of trauma to the abductors after revision total
hip replacement (THR) is unknown. The aim of this prospective study
was to compare the pre- and post-operative status of the gluteus
medius muscle after revision THR. We prospectively compared changes
in the muscle and limping in 30 patients who were awaiting aseptic
revision THR and 15 patients undergoing primary THR. The direct
lateral approach as described by Hardinge was used for all patients.
MRI scans of the gluteus medius and functional analyses were recorded
pre-operatively and six months post-operatively. The overall mean
fatty degeneration of the gluteus medius increased from 35.8% (1.1
to 98.8) pre-operatively to 41% (1.5 to 99.8) after multiple revision
THRs (p = 0.03). There was a similar pattern after primary THR,
but with considerably less muscle damage (p = 0.001), indicating
progressive muscle damage. Despite an increased incidence of a positive
Trendelenburg sign following revision surgery (p = 0.03) there was
no relationship between the cumulative fatty degeneration in the
gluteus medius and a positive Trendelenburg sign (p = 0.26). The
changes associated with other surgical approaches to the hip warrant
investigation. Cite this article:
