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
In 2013, we introduced a specialized, centralized, and interdisciplinary team in our institution that applied a standardized diagnostic and treatment algorithm for the management of prosthetic joint infections (PJIs). The hypothesis for this study was that the outcome of treatment would be improved using this approach. In a retrospective analysis with a standard postoperative follow-up, 95 patients with a PJI of the hip and knee who were treated with a two-stage exchange between 2013 and 2017 formed the study group. A historical cohort of 86 patients treated between 2009 and 2011 not according to the standardized protocol served as a control group. The success of treatment was defined according to the Delphi criteria in a two-year follow-up.Aims
Patients and Methods
The aim of this study was to determine the prevalence and characteristics of C-reactive protein (CRP)-negative prosthetic joint infection (PJI) and evaluate the influence of the type of infecting organism on the CRP level. A retrospective analysis of all PJIs affecting the hip or knee that were diagnosed in our institution between March 2013 and December 2016 was performed. A total of 215 patients were included. Their mean age was 71 years (Aims
Patients and Methods
Despite its intrinsic ability to regenerate form and function after injury, bone tissue can be challenged by a multitude of pathological conditions. While innovative approaches have helped to unravel the cascades of bone healing, this knowledge has so far not improved the clinical outcomes of bone defect treatment. Recent findings have allowed us to gain in-depth knowledge about the physiological conditions and biological principles of bone regeneration. Now it is time to transfer the lessons learned from bone healing to the challenging scenarios in defects and employ innovative technologies to enable biomaterial-based strategies for bone defect healing. This review aims to provide an overview on endogenous cascades of bone material formation and how these are transferred to new perspectives in biomaterial-driven approaches in bone regeneration. Cite this article: T. Winkler, F. A. Sass, G. N. Duda, K. Schmidt-Bleek. A review of biomaterials in bone defect healing, remaining shortcomings and future opportunities for bone tissue engineering: The unsolved challenge.
The aim of this study was to identify the incidence of positive
cultures during the second stage of a two-stage revision arthroplasty
and to analyse the association between positive cultures and an
infection-free outcome. This single-centre retrospective review of prospectively collected
data included patients with a periprosthetic joint infection (PJI)
of either the hip or the knee between 2013 and 2015, who were treated
using a standardised diagnostic and therapeutic algorithm with two-stage
exchange. Failure of treatment was assessed according to a definition
determined by a Delphi-based consensus. Logistic regression analysis
was performed to assess the predictors of positive culture and risk
factors for failure. The mean follow-up was 33 months (24 to 48).Aims
Patients and 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:
