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
Aims. For this retrospective cohort study, patients aged ≤ 30 years
(very young) who underwent total hip arthroplasty (THA) were compared
with patients aged ≥ 60 years (elderly) to evaluate the rate of
revision
There are many guidelines that help direct the management of
patients with metal-on-metal (MOM) hip arthroplasties. We have undertaken
a study to compare the management of patients with MOM hip arthroplasties in
different countries. Six international tertiary referral orthopaedic centres were
invited to participate by organising a multi-disciplinary team (MDT)
meeting, consisting of two or more revision hip arthroplasty surgeons
and a musculoskeletal radiologist. A full clinical dataset including
history, blood tests and imaging for ten patients was sent to each
unit, for discussion and treatment planning. Differences in the
interpretation of findings, management decisions and rationale for
decisions were compared using quantitative and qualitative methods.Aims
Methods
Options for the treatment of subcapital femoral
neck fractures basically fall into two categories: internal fixation
or arthroplasty (either hemiarthroplasty or total hip arthroplasty).
Historically, the treatment option has been driven by a diagnosis-related approach
(non-displaced neck fractures versus displaced neck fractures).
More recently, the traditional paradigm has changed. Instead of
a diagnosis-related approach, it has become more of a patient-related
approach. Treatment options take in to consideration the patient’s age,
functional demands, and individual risk profile. A simple algorithm
can be helpful in terms of directing the treatment. Non-displaced
fractures, regardless of age of the patient, should be treated with
closed reduction and internal fixation. For displaced femoral neck fractures,
the treatment differs depending on the age of the patient. The younger
patient should be treated with urgent ORIF with the goal of an anatomic
reduction. For displaced femoral neck fractures in the elderly,
cognitive function should be determined. For those who are cognitively
functioning, total hip arthroplasty appears to be the best option.
In the cognitively dysfunctional, a bipolar hemiarthroplasty or
a total hip arthroplasty with use of larger heads (32 mm or 36 mm)
and/or constrained sockets are a viable option.
We undertook a randomised prospective follow-up study of changes in peri-prosthetic bone mineral density (BMD) after hip resurfacing and compared them with the results after total hip replacement. A total of 59 patients were allocated to receive a hip resurfacing (n = 29) or an uncemented distally fixed total hip replacement (n = 30). The BMD was prospectively determined in four separate regions of interest of the femoral neck and in the calcar region corresponding to Gruen zone 7 for the hip resurfacing group and compared only to the calcar region in the total hip replacement group. Standardised measurements were performed pre-operatively and after three, six and 12 months. The groups were well matched in terms of gender distribution and mean age. The mean BMD in the calcar region increased after one year to 105.2% of baseline levels in the resurfaced group compared with a significant decrease to 82.1% in the total hip replacement group (p <
0.001) by 12 months. For the resurfaced group, there was a decrease in bone density in all four regions of the femoral neck at three months which did not reach statistical significance and was followed by recovery to baseline levels after 12 months. Hip resurfacing did indeed preserve BMD in the inferior femoral neck. In contrast, a decrease in the mean BMD in Gruen zone 7 followed uncemented distally fixed total hip replacement. Long term follow-up studies are necessary to see whether this benefit in preservation of BMD will be clinically relevant at future revision surgery.
We report the use of an allograft prosthetic composite for reconstruction of the skeletal defect in complex revision total hip replacement for severe proximal femoral bone loss. Between 1986 and 1999, 72 patients (20 men, 52 women) with a mean age of 59.9 years (38 to 78) underwent reconstruction using this technique. At a mean follow-up of 12 years (8 to 20) 57 patients were alive, 14 had died and one was lost to follow-up. Further revision was performed in 19 hips at a mean of 44.5 months (11 to 153) post-operatively. Causes of failure were aseptic loosening in four, allograft resorption in three, allograft nonunion in two, allograft fracture in four, fracture of the stem in one, and deep infection in five. The survivorship of the allograft-prosthesis composite at ten years was 69.0% (95% confidence interval 67.7 to 70.3) with 26 patients remaining at risk. Survivorship was statistically significantly affected by the severity of the pre-operative bone loss (Paprosky type IV; p = 0.019), the number of previous hip revisions exceeding two (p = 0.047), and the length of the allograft used (p = 0.005).
We have reviewed 42 patients who had revision of metal-on-metal resurfacing procedures, mostly because of problems with the acetabular component. The revisions were carried out a mean of 26.2 months (1 to 76) after the initial operation and most of the patients (30) were female. Malpositioning of the acetabular component resulted in 27 revisions, mostly because of excessive abduction (mean 69.9°; 56° to 98°) or insufficient or excessive anteversion. Seven patients had more than one reason for revision. The mean increase in the diameter of the component was 1.8 mm (0 to 4) when exchange was needed. Malpositioning of the components was associated with metallosis and a high level of serum ions. The results of revision of the femoral component to a component with a modular head were excellent, but four patients had dislocation after revision and four required a further revision.
Wear of metal-on-metal bearings causes elevated levels of cobalt and chromium in blood and body fluids. Metal-on-metal bearings have two distinct wear phases. In the early phase, the wear rate is high. Later, it decreases and the bearing enters a steady-state phase. It is expected that as the wear rates decline, the level of cobalt detected in plasma will also decrease. We studied the baseline and exercise-related cobalt rise in 21 patients (13 men and eight women) with a mean age of 54 years (38 to 80) who had undergone successful hip resurfacing at a mean of 44 months (10 to 96) earlier. Our results showed that circulating baseline cobalt levels were not significantly correlated with the time since implantation (r = 0.08, p = 0.650). By contrast, the exercise-related cobalt rise was directly correlated with the inclination angle of the acetabular component (r = 0.47, p = 0.032) and inversely correlated with the time since implantation (r = −0.5, p = 0.020). Inclination of the acetabular component should be kept less than 40° to decrease the production of wear debris.
Few independent studies have reported the outcome of resurfacing arthroplasty of the hip. The aim of this study was to report the five-year clinical outcome and seven-year survival of an independent series. A total of 610 Birmingham Hip Resurfacing arthroplasties were performed in 532 patients with a mean age of 51.8 years (16.5 to 81.6). They were followed for between two and eight years; 107 patients (120 hips) had been followed up for more than five years. Two patients were lost to follow-up. At a minimum of five years’ follow-up, 79 of 85 hips (93%) had an excellent or good outcome according to the Harris hip score. The mean Oxford hip score was 16.1 points ( Considering that these patients are young and active these results are good, and support the use of resurfacing. Further study is needed to address the early failures, particularly those related to fracture and metal debris.
New brands of joint prosthesis are released for general implantation with limited evidence of their long-term performance in patients. The CUSUM continuous monitoring method is a statistical testing procedure which could be used to provide prospective evaluation of brands as soon as implantation in patients begins and give early warning of poor performance. We describe the CUSUM and illustrate the potential value of this monitoring tool by applying it retrospectively to the 3M Capital Hip experience. The results show that if the clinical data and methodology had been available, the CUSUM would have given an alert to the underperformance of this prosthesis almost four years before the issue of a Hazard Notice by the Medical Devices Agency. This indicates that the CUSUM can be a valuable tool in monitoring joint prostheses, subject to timely and complete collection of data. Regional or national joint registries provide an opportunity for future centralised, continuous monitoring of all hip and knee prostheses using these techniques.