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
While an increasing amount of arthroplasty articles
report comorbidity measures, none have been validated for outcomes.
In this study, we compared commonly used International Classification
of Diseases-based comorbidity measures with re-operation rates after
total hip replacement (THR). Scores used included the Charlson,
the Royal College of Surgeons Charlson, and the Elixhauser comorbidity
score. We identified a nationwide cohort of 134 423 THRs from the
Swedish Hip Arthroplasty Register. Re-operations were registered
post-operatively for up to 12 years. The hazard ratio was estimated
by Cox’s proportional hazards regression, and we used C-statistics
to assess each measure’s ability to predict re-operation. Confounding
variables were age, gender, type of implant fixation, hospital category,
hospital implant volume and year of surgery. In the first two years only the Elixhauser score showed any significant
relationship with increased risk of re-operation, with increased
scores for both one to two and three or more comorbidities. However,
the predictive C-statistic in this period for the Elixhauser score
was poor (0.52). None of the measures proved to be of any value between
two and 12 years. They might be of value in large cohort or registry
studies, but not for the individual patient. Cite this article:
We describe the results of cemented total hip replacement in 23 patients (23 hips) with active tuberculous arthritis of the hip with a mean follow-up of 4.7 years (4 to 7). In two patients the diagnosis was proved by pre-operative biopsy, whereas all others were diagnosed on a clinicoradiological basis with confirmation obtained by histopathological examination and polymerase chain reaction of tissue samples taken at the time of surgery. All patients received chemotherapy for at least three months before surgery and treatment was continued for a total of 18 months. Post-operative dislocation occurred in one patient and was managed successfully by closed reduction. No reactivation of the infection or loosening of the implant was recorded and function of the hip improved in all patients. Total hip replacement in the presence of active tuberculous arthritis of the hip is a safe procedure when pre-operative chemotherapy is commenced and continued for an extended period after operation.
In Africa the amount of joint replacement surgery is increasing, but the indications for operation and the age of the patients are considerably different from those in the developed world. New centres with variable standards of care and training of the surgeons are performing these procedures and it is important that a proper audit of this work is undertaken. In Malawi, we have pioneered a Registry which includes all joint replacements that have been carried out in the country. The data gathered include the age, gender, indication for operation, the prosthesis used, the surgical approach, the use of bone graft, the type of cement, pressurising systems and the thromboprophylaxis used. All patients have their clinical scores recorded pre-operatively and then after three and six months and at one year. Before operation all patients are counselled and on consent their HIV status is established allowing analysis of the effect of HIV on successful joint replacement. To date, 73 total hip replacements (THRs) have been carried out in 58 patients by four surgeons in four different hospitals. The most common indications for THR were avascular necrosis (35 hips) and osteoarthritis (22 hips). The information concerning 20 total knee replacements has also been added to the Registry.
We performed 96 Birmingham resurfacing arthroplasties of the hip in 71 consecutive patients with avascular necrosis of the femoral head. A modified neck-capsule-preserving approach was used which is described in detail. The University of California, Los Angeles outcome score, the radiological parameters and survival rates were assessed. The mean follow-up was for 5.4 years (4.0 to 8.1). All the patients remained active with a mean University of California, Los Angeles activity score of 6.86 (6 to 9). Three hips failed, giving a cumulative survival rate of 95.4%. With failure of the femoral component as the endpoint, the cumulative survival rate was 98.0%. We also describe the combined abduction-valgus angle of the bearing couple, which is the sum of the inclination angle of the acetabular component and the stem-shaft angle, as an index of the optimum positioning of the components in the coronal plane. Using a modified surgical technique, it is possible to preserve the femoral head in avascular necrosis by performing hip resurfacing in patients with good results.
