Aims

Asphericity of the femoral head-neck junction is common in cam-type femoroacetabular impingement (FAI) and usually quantified using the alpha angle on radiographs or MRI. The aim of this study was to determine the natural alpha angle in a large cohort of patients by continuous circumferential analysis with CT.

Introduction

Recently used hip resurfacing systems remove bone, ream away the subchondral bone stock and reduce biomechanical properties of the femoral neck. Since much bone was removed from the head, the biomechanical properties decrease. The Onlay Resurfacing technique preserves complete bone stock and individual anatomy without any change in offset or leg length. To quantify the clinical outcome and adverse events a group receiving standard total hip arthroplasty was designed as control.

Background: A total hip arthroplasty system with 3-dimensional interconnecting surface topography was developed for optimum osseous integration and long term stability. The present study was performed to assess long-term implant survival and function.

Methods: We prospectively studied a consecutive series of 100 cementless total hip arthroplasties in 94 patients using the ESKA GHE cementless spongy metal hip replacement. Study end-point was implant revision, and both function as well as satisfaction with treatment outcome was assessed after a mean follow-up of 18 years.

Results: Mean age at the time of operation was 47 years [range 18–65]. Seven patients were lost to follow-up. 11 patients had died for unrelated reasons at 14.1 ± 4.3 years after surgery with all 14 hip replacements in situ. Consequently, at a mean follow-up of 18 years [15.3 – 20.3], 74 patients (74 hips) could be included in the final analysis. Survival with aseptic loosening as the endpoint was 95% for the femoral component and 85% for the acetabular component. Two cups had to be revised for recurrent dislocation, resulting in a total implant survival at follow-up of 95% for the femoral component and 81% for the acetabular component.

Very good functional results were obtained with an improvement of the mean Merle d’Aubigné score from 9.5 ± 2.0 at baseline to 15.0 ± 3.1 at follow-up, and 86% excellent or good results (McNab score). Satisfaction with treatment outcome was high, and 96% of patients would recommend the performed procedure to a friend.

Conclusion: Excellent survival rates were observed in a young patient population after cementless hip arthroplasty with the GHE spongy metal hip replacement at a mean follow-up of eighteen years. Thus, modern cementless hip replacement shows long-term survival and might be favourable in young and active patients.

Context: Published data on extracorporeal shock wave therapy (ESWT) for heel pain provide controversial evidence about the clinical effectiveness. In previous studies, three interventions of ESWT without local anaesthesia demonstrated excellent outcome.

Objective: To give confirmatory proof of effectiveness and safety of focused ESWT administered without local anaesthesia in the treatment of chronic painful heel syndrome.

Design and Participants: Prospective, double-blind, randomized, placebo-controlled multicenter FDA trial conducted among 250 patients.

Interventions: ESWT (0.25 mJ/mm²) or placebo. Both groups received three interventions of 2000 shock wave impulses, each session 1 week apart.

Main Outcome Measures: The primary outcome was the percentage change of heel pain quantified by VAS composite score, as well as the change of Roles and Maudsley score at 12 weeks after the last intervention compared to baseline. Secondary endpoints were defined as single success rates (more than 60% reduction of morning pain, pain at daily activities, and pain with force-meter), overall success rate, physician’s judgment of effectiveness; patient’s satisfaction with outcome, patient’s willingness to recommend treatment, and subject’s analgesic medication consumption.

Results: Follow-up was excellent with 246 patients (98.4%) available for intention-to-treat analysis at 12-week follow-up. ESWT resulted in a 69.2% reduction of heel pain regarding the primary endpoint VAS composite score compared to baseline, compared to 34.5% for placebo (p=0.0027, one-sided). ESWT was also significantly superior to placebo for the Roles and Maudsley score (p=0.0006, one-sided). The combined overall result of the eight secondary criteria also showed statistical significance (P = 0.0015 one-sided, multivariate directional Wilcoxon-Mann-Whitney test). No clinically relevant device-related adverse events were recorded.

Conclusion: The results of the present study provide confirmatory proof of effectiveness of ESWT without local anaesthesia in the treatment of refractory painful heel syndrome.

Introduction: The extracorporeal shock wave therapy (ESWT) has a wide spectrum of indication in orthopaedics. However, infection in the application area is regarded as a contraindication. Therefore, in this study, the effect of of ESW on bacteria and their interaction with antibiotics is tested.

Methods: Standardized suspensions of S. aureus (ATCC25923) were exposed to different energy flux densities (EFD 0,38–0,96 mJ/mm²) and different impulse quantities (1000–12000 impulses) of a focussed ESWT. The surviving bacteria were quantified and compared to an untreated control group. The permeability of the cell wall of treated bacteria was analysed with a fluorescence assay and the DNA examined qualitatively for defects.

The influence of ESW on the effectiveness of antibiotics was examined using Gentamicin whose stability under influence of ESW was proven infrared-spectrometrically earlier.

S. aureus in specific broth (CAMHB) was treated with 4000 impulses at 0.59 mJ/mm². Then the MIC against Gentamicin was compared with the MIC of an untreated control group.

For the examination of synergistic effects between antibiotics and ESW, bacteria were treated with ESW (4000 impulses, 0.59 mJ/mm²) in a solution of CAMHB and varying Gentamicin concentrations (0.25 – 4 μ g/ml).

The vital bacteria were quantified and compared to the control group which was exposed to either ESW or Gentamicin. Bacterium colonies were quantified according to the guidelines of the NCCLS, the statistical evaluation was done with the Man-Whitney-U- test.

Results: The ESW showed a significant germicidal effect (P < 0.01) after application of either a high EFD (> 0.60 mJ/mm², 4000 impulses) or a high impulse quantitiy at low EFD (up to 12,000 impulses, < 0.60 mJ/mm²). The amount of CFU could be reduced by up to 99.9%.

Despite the germicidal effect of the ESWT neither a change of the bacterium cell permeability nor a damage to the DNA could be proved. Synergistic effects between Gentamicin and ESW were not found. No loss of effectivity of the Gentamicins at a simultaneous application of the ESW (P > 0.05) could be seen either.

Conclusion: The ESWT has a significant germicidal effect on bacteria after exceeding a certain threshold energy.

It could be shown that the applied total energy is responsible for the germicidal effect rather than single paramters as EFD and impulse quantity. A synergistic effect of antibiotics applied in addition to the ESW could not be proved. When ESW was carried out in presence of Gentamicin, the antibacterial effect of Gentamicin was influenced neither positively nore negatively.

The simultaneous application of ESW and systemically or locally applied antibiotics could represent a new therapy approach against tissue and bone infections. To prove this, further in-vivo studies are needed.

Context: Published data on extracorporeal shock wave therapy (ESWT) for chronic plantar fasciitis provide controversial evidence about the clinical relevance and effectiveness. Treatment parameters have significant influence on outcome and optimal treatment protocols have to be determined.

Objective: To assess the effect size and safety of ESWT compared to placebo in the treatment of chronic painful heel syndrome with a new electromagnetic device and an optimized protocol.

Design, Setting, and Participants: Prospective, double-blind, randomized, placebo-controlled trial conducted among 40 patients. Interventions: ESWT (0.25 mJ/mm²) or placebo without anesthesia. Both groups received 3 treatments of 2000 shock wave impulses, each session 1 week apart. Main Outcome Measures: The primary outcome was the percentage change of heel pain quantified by VAS composite score 12 weeks after the last intervention compared to baseline. Secondary endpoints were defined as changes of single VAS scores (morning pain, pain at daily activities and pain with force-meter application), success rates and changes in Roles and Maudsley score.

Results: ESWT resulted in a 73.2% reduction of heel pain regarding the primary endpoint VAS composite score compared to baseline, being 32.7% superior to placebo. Effect size reached clinical relevance (Mann-Whitney effect size (MW) = 0.6737; 0.6400 being the benchmark for medium-sized, relevant superiority, p = 0.0302 single-sided). With regard to the percentage changes of the single VAS scores and the Roles and Maudsley score, the effect size denoted relevant superiority of the ESWT as well (all MWs ≥ 0.6400). No relevant adverse events occurred.

Conclusion: The results of the present study advocate ESWT for refractory painful heel syndrome demonstrating clinically relevant effect sizes. Specific treatment protocols with proven effectiveness ought to be used in the clinical setting.

Introduction: Extracorporeal shock wave therapy (ESWT) covers a multitude of different indications in modern orthopedics, however, bacterial infections are still considered as contraindications. The goal of the present study was to determine the effect of ESWT on growth of clinically relevant bacteria in orthopedic and trauma surgery.

Methods: Standardised suspensions of a methicillin sensitive and a methicillin resistant strain of Staphylococcus aureus, and reference strains of Staphylococcus epidermidis, Pseudomonas aeruginosa and Enterococ-cus faecalis were subjected to 4000 impulses of high-energy shock waves with an energy flux density (EFD) of 0.96 mJ/mm2 and a frequency of 2 Hz. Furthermore, corresponding suspensions of S. aureus ATCC 25923 were exposed to different impulse rates of shock waves (1000 to 6000 impulses) and to different EFDs up to a maximum of 0.96 mJ/mm2 (2 Hz) to evaluate the influence of shock wave parameters. Subsequently, viable bacteria were quantified by culture and compared with an untreated control.

Results: A highly significant antibacterial effect of the ESWT was demonstrated for all bacterial strains with a reduction of growth to values between 1,1% and 29,7% (P < 0.01). Reference strains of S. aureus and S. epidermidis reacted most sensitive whereas E. faecium demonstrated highest resistance against high-energy shock waves. After applying different energy levels to S. aureus, a significant bactericidal effect was observed only with a minimum threshold EFD of 0.59 mJ/mm2 (P < 0.05). A threshold impulse rate of more than 1000 impulses could be defined to reduce bacterial growth of S. aureus (P < 0.05). Further elevation of energy and impulse rate exponentially increased bacterial killing.

Conclusions: ESWT proved to exert significant antibacterial effect in an energy-dependent manner. The results suggest that infections are not necessarily contraindications to shock wave therapy and could even represent a new indication for ESWT. However, clinical relevance should be assessed in vivo in an animal model.

Introduction: During the last years minimal-invasive augmentation techniques of vertebral bodies have been established to stabilize painful height losses. Kyphoplasty was described in osteoporotic fractures for stabilisation and high restoration of the collapsed vertebral body. Kyphoplasty intends to achieve a reduction of kyphosis prior to cementing.

Aim: The study was performed to analyze the Kyphoplasty technique in patients with tumour induced back pain due to affected vertebral bodies.

Method: 7 Patients with Tumour induced back pain were enrolled. MRI, CT and x-ray were performed to confirm the diagnosis and for staging. All patients have severe and significant back pain. Primary spine tumours were excluded. To evaluate the clinical outcome the Oswestry

Score and McNab Score were used. CT scans after procedure were performed to detect cement extrusion. The follow up examinations 12 weeks after Kyphoplasty were performed by an independent blinded observer.

Results: 6 patients complete 12 week follow up. All subjects reported significant subjective improvement on the McNab Score (2 excellent, 3 good,1 moderate outcome.) Oswestry Score showed the same results (74±12 Pts at Baseline and 28±9 at 12 week follow up).

Purpose: To determine the effectiveness of rESWT for chronic plantar heel pain.

Materials and methods: 70 patients were enrolled and randomly assigned to either active or placebo treatment. 2000 shock waves per session and 3 sessions were applied, interval of 2 weeks. The primary efficacy criteria were subjective outcome on Visual Analogue Scale (VAS) and Roles- and Maudsley-Score. The primary study endpoint was 12 weeks. Nonparametric procedures have been used for teststatistical analyses. In addition to P-values, results have been presented by means of Mann-Whitney estimators as nonparametric effect sizes and their one-sided 97.5% confidence intervals as required by the ICH E9 Guideline ( Exact Wilcoxon-Mann-Whitney test, ï ¡ = 0.025 one-sided)

Results: 62 patients could be examined 12 weeks after rESWT. Drop out rate 12%. Significant decrease in pain sensation could be found in the active group (p< 0, 001). The VAS decreased from 7.1 (+/− 1,6) to 3.6 (+/− 2,3). Placebo group showed slight improvement from 6.7 (+/−1,8) to 5.9 (+/− 2,2). The effect size (Mann-Whitney) denotes a large superiority of the rESWT group (MW = 0.72). The lower bound of the asymptotic one-sided 97.5% confidence interval denotes superiority of the test group (LB-CI = 0.58). The results scored on Roles- and Maudsley-Score showed similar improvement. Only minor side effects as petechial bleeding and swelling were detected.

Conclusion: The radial shock wave therapy is effective and save in treatment of chronic heel pain.

We have to deal with an increasing number of patients who are suffering from a femoral neck fracture. In Ger-many in 1996 135.000 patients with this kind of fracture were treated. These fractures are usually found in old people and have a high complication rate:

Osteonecrosis of the femoral head: 12–43% (Kyle 1994)

Pseudarthrosis: 16–28% (Rogmark 2002)

The indications for a total hip replacement are:

– age > 65years

– presence of osteoporosis (also under 65)

– daily activity possible (otherwise hemialloarthroplasty)

– comorbidity such as osteoarthritis

We have to consider several aspects:

The mortality rate is lower if we use a hip replacement (THR ~6%, osteosynthesis ~10%) The complication rate is lower if we use hip replacement (THR ~2%, osteosynthesis ~5%) In 30% of cases we have to change from osteosynthesis to a total hip replacement due to secondary complications of osteosynthesis in mobile patients If we look at this data, we must conclude that total hip replacement is the goldstandard in the treatment of femoral neck fractures (with Garden III and IV) in the population older than 65 years. Hemialloarthroplasty is only indicated for patients who are more or less immobilized.

The aim of the study was to evaluate changes in clinical results after extracorporeal shock wave therapy (ESWT) on calcified lesions of the shoulder.

963 patients with calcifying tendinitis were treated with high energy shock waves. The mean energy flux density was 0. 28 mJ/mm2. To evaluate the effect we used the visual analogue scale (VAS) and the Roles-Maudsley-score to analyse the effect on activity of daily living, and pain perception. ESWT was indicated after non operative treatment failed.

At 12 months after ESWT, 73. 6% of patients reported excellent and good results, 26% scored satisfactory and poor, using the Roles-Maudsley-Score. The positive effect of the ESWT on pain perception after 12 months was statistically significant (p< 0. 001). The difference between pain perception before and after ESWT persisted in the follow up interval. No decrease was shown after 2 years. In all cases no severe side effects were observed except small petechial haemorrhages.

High energy shock wave therapy is indicated to treat calcifying tendinitis which is resistant to any other non-operative treatment. The decrease in pain perception persists over a period of more than two years. Absence of side effects and its effectiveness suggest that ESWT is indicated prior to surgical intervention.

The cranial cup is now a standardised implant in acetabular revision surgery. In order to illustrate the positive results of a standardised implant in acetabular revision surgery in comparison to other possibilities of reconstruction, we analysed results of all data in our study group.

Aseptic loosening of implants often causes segmental and cavitary acetabular deficiency. Experiences gained in radical tumour surgery with reconstruction by custommade endoprostheses induced the development of the cranial cup for revision total hip arthroplasty. This new cementless revision cup has an oval shape and a special cranial flap, as well as an intramedullary rod if necessary.

This type of cranial cup has been used since 1993. From 9/97 to 1/99, we implanted 30 cranial cups in revision hip surgery and collected all data of these patients prospectively. Clinical and x-ray follow-up was documented on a regular basis.

Acetabular deficiency occurred twice in type 1, five times in type 2, twenty-two times in type 3 and once in type 4. The AAOS D’Antonio score was used. Cranial cups were implanted without cranial flap in 10 cases, with cranial flap in 20 cases and once using the intramedullary rod additionally. Only 28 patients were included in our last examination because one patient had died and one was bedridden because of a reason other than the hip. The Harris hip score increased from an average of 32 points preoperatively to 63 points postoperatively. Twenty-one patients are satisfied or very satisfied with their surgery. Radiograph examinations showed an average inclination angle of 42.5° in all cranial cups.

Up to now there have been complications in four patients who suffered luxations, but only one required a change of inlay. One intraoperative injury of the urinary bladder had to be revised later. Three implants showed a change of position in x-ray. One was the patient with the urinary bladder injury and possible septic loosening, the second was a patient with extreme osteoporosis, and the third was a patient who did not receive an intramedullary rod for a type 4 lesions. Currently, these three patients do not have any complaints.

We have always achieved primary stability. Morselised bone autografts or bone substitute materials were used to fill remaining defects. An intramedullary rod should be used in pelvis discontinuity and is obligatory to achieve the necessary stability. Developed from the experiences of custom-made tumour endoprostheses, the cranial cup with all possible variations is an appropriate intraoperative variable implant in revision acetabular surgery.