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1.
Children (Basel) ; 9(5)2022 May 20.
Article in English | MEDLINE | ID: mdl-35626931

ABSTRACT

(1) Background: Diaphyseal forearm fractures are a common injury in children and adolescents. When operative treatment is needed, elastic stable intramedullary nailing (ESIN) is the most common surgical procedure. Although there is no clear evidence, hardware removal after fracture healing is performed in many patients. Often, the primary minimal invasive incision needs to be widened during implant removal. In order to decrease the burden of care of pediatric fractures, significant efforts were made to develop biodegradable implants, which make hardware removal unnecessary. Our study will conduct an observational trial on the clinical use of the Activa IM-Nail™ in forearm fractures in children between 3 and 13 years of age. The objective of this trial is to evaluate the risks and benefits of the Activa IM-Nail™. Among other objectives, the rate of refracture will be determined. (2) Methods: An international Europe-based, multicenter, prospective, single-arm, open-label study will be performed to ascertain the rate of refracture and to determine the subjective benefits of Activa IM-Nail™ for patients, parents and other caregivers. The study will include clinical follow-up including early post-operative complication, radiographs until bony healing and an additional follow-up after 1 year. At this stage, preliminary results and early complications on 76 patients are analyzed in this study and presented. (3) Results: As of April 2022, 76 patients were enrolled as per study protocol. There were 31 girls (40.8%) and 45 boys (59.2%). The mean age at the time of inclusion was 8.9 years (±2.4 years). The mean operation time was 58.9 ± 22.9 min (range, 15-119 min). The mean follow-up time was 8.9 ± 5.1 months (range, 0.2-18.6). Up to now, one refracture has occurred in one child falling from a height of about one meter 7 months after index surgery (1/76; 1.3%). (4) Conclusion: The research project assesses the safety and effectiveness of Activa IM-Nails™ as part of the surgical treatment of dislocated forearm fractures in children in the context of a PMCF study. The use of Activa IM-Nails™ with regard to various objectives, including postoperative complications and refracture rate, seems to be equal to the standard titan ESIN procedure compared to the literature. Preliminary results are encouraging and are made available.

2.
Int Orthop ; 39(7): 1269-75, 2015 Jul.
Article in English | MEDLINE | ID: mdl-25522801

ABSTRACT

PURPOSE: Despite the fact that new and modern short-stems allow bone sparing and saving of soft-tissue and muscles, we still face the challenge of anatomically reconstructing the femoro-acetabular offset and leg length. Therefore a radiological and clinical analysis of a short-stem reconstruction of the femoro-acetabular offset and leg length was performed. METHODS: Using an antero-lateral approach, the optimys short-stem (Mathys Ltd, Bettlach, Switzerland) was implanted in 114 consecutive patients in combination with a cementless cup (Fitmore, Zimmer, Indiana, USA; vitamys RM Pressfit, Mathys Ltd, Bettlach, Switzerland). Pre- and postoperative X-rays were done in a standardized technique. In order to better analyse and compare X-ray data a special double coordinate system was developed for measuring femoral- and acetabular offset. Harris hip score was assessed before and six weeks after surgery. Visual analogue scale (VAS) satisfaction, leg length difference and the existence of gluteal muscle insufficiency were also examined. RESULTS: Postoperative femoral offset was significantly increased by a mean of 5.8 mm. At the same time cup implantation significantly decreased the acetabular offset by a mean of 3.7 mm, which resulted in an increased combined femoro-acetabular offset of 2.1 mm. Postoperatively, 81.7% of patients presented with equal leg length. The maximum discrepancy was 10 mm. Clinically, there were no signs of gluteal insufficiency. No luxation occurred during hospitalization. The Harris hip score improved from 47.3 before to 90.1 points already at six weeks after surgery while the mean VAS satisfaction was 9.1. CONCLUSION: The analysis showed that loss of femoro-acetabular offset can be reduced with an appropriate stem design. Consequently, a good reconstruction of anatomy and leg length can be achieved. In the early postoperative stage the clinical results are excellent.


Subject(s)
Acetabulum/surgery , Arthroplasty, Replacement, Hip/methods , Femur/surgery , Hip Joint/surgery , Acetabulum/diagnostic imaging , Adult , Aged , Aged, 80 and over , Female , Femur/diagnostic imaging , Hip Joint/diagnostic imaging , Hip Prosthesis , Humans , Leg Length Inequality , Male , Middle Aged , Postoperative Period , Prospective Studies , Radiography
3.
Knee Surg Sports Traumatol Arthrosc ; 19(9): 1453-9, 2011 Sep.
Article in English | MEDLINE | ID: mdl-21302046

ABSTRACT

PURPOSE: Total knee arthroplasty (TKA) disturbs patellar blood flow, an unintended accompaniment to TKA that may be a cause of postoperative anterior knee pain. We examine whether disrupted patellar blood flow correlates with anterior knee pain following TKA. METHODS: In 50 patients (21 men, 29 women) undergoing TKA, we compared patellar blood flow at flexions 0° to 30°, 60°, 90°, and 110° before and after medial parapatellar arthrotomy to pre- and postoperative anterior knee pain scores by means of a laser Doppler flowmeter (LDF) probe. Anterior knee pain was assessed using the pain intensity numeric rating scale (NRS) of 0-10 (0-no, 10-worst pain). Based on the NRS pain values, patients were divided into two main groups: group A (n = 34) with no pain or discomfort (NRS range 0-4) and group B (n = 16) with anterior knee pain (NRS range 5-10). RESULTS: Patients of group B demonstrated a significant decrease in blood flow before arthrotomy at flexions from 0° to 90°, and 110° and from 0° to 60°, 90°, and 110° after arthrotomy. For group A, a significant decrease in blood flow was detected at flexions from 0° to 90°, and 110° before and after arthrotomy. For both groups, medial arthrotomy did not have a statistically significant influence on patellar blood flow (margin of significance P < 0.05). Prior to TKA, 16 of the 50 patients of group B (32%) complained of anterior knee pain (mean NRS 7.1 ± 1.7). At 2-year follow-up, pain significantly decreased (NRS 3.1 ± 2.1) and only 4 of the 16 patients (25%) complained of moderate anterior pain (average NRS 5.7 ± 0.5), while 8 of 16 (50%) patients reported discomfort (mean NRS 3.5 ± 1.8) around the patella. Patients in group A also demonstrated a significant decrease in pain intensity (from NRS 1.5 ± 1.4 preoperatively to NRS 0.4 ± 1.5 at 2-year follow-up). Statistical analysis demonstrated no statistically significant correlation between pre-arthrotomy/post-arthrotomy patellar blood flow and the presence of preoperative and postoperative anterior knee pain. Only the degree of flexion had an influence on patellar blood flow. CONCLUSION: Medial arthrotomy had no direct significant effect on patellar blood flow, and the diminished blood flow did not correlate with postoperative anterior knee pain. However, a significant correlation was revealed between patellar blood flow and the degree of flexion: in almost a quarter of patients, blood flow dropped to zero at flexions of 100° and above.


Subject(s)
Arthroplasty, Replacement, Knee/adverse effects , Osteoarthritis, Knee/surgery , Pain, Postoperative/diagnosis , Patella/blood supply , Patellofemoral Pain Syndrome/etiology , Range of Motion, Articular/physiology , Aged , Aged, 80 and over , Arthroplasty, Replacement, Knee/methods , Cohort Studies , Female , Follow-Up Studies , Humans , Knee Joint/blood supply , Laser-Doppler Flowmetry , Male , Osteoarthritis, Knee/diagnostic imaging , Pain Measurement , Pain, Postoperative/etiology , Patellofemoral Pain Syndrome/physiopathology , Radiography , Regional Blood Flow/physiology , Risk Assessment , Severity of Illness Index
4.
Knee ; 18(6): 464-9, 2011 Dec.
Article in English | MEDLINE | ID: mdl-20947358

ABSTRACT

We report a series of 16 consecutive total knee arthroplasty (TKA) revision procedures for deep infection, treated with a newly developed intraoperatively moulded PMMA cement-prostheses-like spacer (CPLS). The standard treatment consisted of a two-stage protocol with initial explantation of the infected components combined with radical debridement, followed by implantation of a temporary cement spacer and final reimplantation of a new TKA. A sterilizeable Teflon tapered aluminium mould was developed for production of a custom made CPLS during the intervention. Stable implantation of the CPLS was achieved with a second cementation, allowing for correct alignment and ligament balancing. The spacer remained 3.5 months on average until reimplantation of a TKA occurred. At time of reimplantation, patients had an average KSS score of 84.44 points with an average flexion capacity of 102°. There was no recurrent infection during the study period of minimum 2 years. With this new technique, a low friction articulation with good stability, high comfort and a better range of motion compared to handcrafted spacers was achieved. The use of this spacer is a time sparing, cheap and convenient option in 2-stage TKA revision.


Subject(s)
Arthroplasty, Replacement, Knee , Knee Joint/surgery , Knee Prosthesis , Polymethyl Methacrylate , Prosthesis Design , Prosthesis-Related Infections/surgery , Aged , Aged, 80 and over , Arthroplasty, Replacement, Knee/instrumentation , Arthroplasty, Replacement, Knee/methods , Bone Cements , Cementation , Female , Humans , Intraoperative Period , Knee Joint/pathology , Male , Middle Aged , Prospective Studies , Prosthesis-Related Infections/pathology , Reoperation , Treatment Outcome
5.
Eur Spine J ; 19(6): 916-23, 2010 Jun.
Article in English | MEDLINE | ID: mdl-20191393

ABSTRACT

Vertebroplasty and kyphoplasty are well-established minimally invasive treatment options for compression fractures of osteoporotic vertebral bodies. Possible procedural disadvantages, however, include incomplete fracture reduction or a significant loss of reduction after balloon tamp deflation, prior to cement injection. A new procedure called "vertebral body stenting" (VBS) was tested in vitro and compared to kyphoplasty. VBS uses a specially designed catheter-mounted stent which can be implanted and expanded inside the vertebral body. As much as 24 fresh frozen human cadaveric vertebral bodies (T11-L5) were utilized. After creating typical compression fractures, the vertebral bodies were reduced by kyphoplasty (n = 12) or by VBS (n = 12) and then stabilized with PMMA bone cement. Each step of the procedure was performed under fluoroscopic control and analysed quantitatively. Finally, static and dynamic biomechanical tests were performed. A complete initial reduction of the fractured vertebral body height was achieved by both systems. There was a significant loss of reduction after balloon deflation in kyphoplasty compared to VBS, and a significant total height gain by VBS (mean +/- SD in %, p < 0.05, demonstrated by: anterior height loss after deflation in relation to preoperative height [kyphoplasty: 11.7 +/- 6.2; VBS: 3.7 +/- 3.8], and total anterior height gain [kyphoplasty: 8.0 +/- 9.4; VBS: 13.3 +/- 7.6]). Biomechanical tests showed no significant stiffness and failure load differences between systems. VBS is an innovative technique which allows for the possibly complete reduction of vertebral compression fractures and helps maintain the restored height by means of a stent. The height loss after balloon deflation is significantly decreased by using VBS compared to kyphoplasty, thus offering a new promising option for vertebral augmentation.


Subject(s)
Fractures, Compression/surgery , Kyphoplasty/methods , Osteoporosis/complications , Spinal Fractures/surgery , Spine/surgery , Stents/standards , Aged , Cadaver , Female , Fractures, Compression/diagnostic imaging , Fractures, Compression/pathology , Humans , Male , Middle Aged , Osteoporosis/surgery , Outcome Assessment, Health Care/methods , Prosthesis Implantation/methods , Radiography , Spinal Fractures/diagnostic imaging , Spinal Fractures/pathology , Spine/diagnostic imaging , Spine/pathology , Stents/adverse effects , Treatment Outcome
7.
Eur Spine J ; 17(9): 1201-9, 2008 Sep.
Article in English | MEDLINE | ID: mdl-18446386

ABSTRACT

With an official life time of over 5 years, Spine Tango can meanwhile be considered the first international spine registry. In this paper we present an overview of frequency statistics of Spine Tango for demonstrating the genesis of questionnaire development and the constantly increasing activity in the registry. Results from two exemplar studies serve for showing concepts of data analysis applied to a spine registry. Between 2002 and 2006, about 6,000 datasets were submitted by 25 centres. Descriptive analyses were performed for demographic, surgical and follow-up data of three generations of the Spine Tango surgery and follow-up forms. The two exemplar studies used multiple linear regression models to identify potential predictor variables for the occurrence of dura lesions in posterior spinal fusion, and to evaluate which covariates influenced the length of hospital stay. Over the study period there was a rise in median patient age from 52.3 to 58.6 years in the Spine Tango data pool and an increasing percentage of degenerative diseases as main pathology from 59.9 to 71.4%. Posterior decompression was the most frequent surgical measure. About one-third of all patients had documented follow-ups. The complication rate remained below 10%. The exemplar studies identified "centre of intervention" and "number of segments of fusion" as predictors of the occurrence of dura lesions in posterior spinal fusion surgery. Length of hospital stay among patients with posterior fusion was significantly influenced by "centre of intervention", "surgeon credentials", "number of segments of fusion", "age group" and "sex". Data analysis from Spine Tango is possible but complicated by the incompatibility of questionnaire generations 1 and 2 with the more recent generation 3. Although descriptive and also analytic studies at evidence level 2++ can be performed, findings cannot yet be generalised to any specific country or patient population. Current limitations of Spine Tango include the low number and short duration of follow-ups and the lack of sufficiently detailed patient data on subgroup levels. Although the number of participants is steadily growing, no country is yet represented with a sufficient number of hospitals. Nevertheless, the benefits of the project for the whole spine community become increasingly visible.


Subject(s)
International Cooperation , Registries , Spinal Diseases/surgery , Spinal Fusion/statistics & numerical data , Adolescent , Adult , Aged , Aged, 80 and over , Child , Female , Health Surveys , Humans , Length of Stay/statistics & numerical data , Logistic Models , Male , Middle Aged , Professional Competence/statistics & numerical data , Young Adult
8.
J Forensic Leg Med ; 15(3): 135-40, 2008 Apr.
Article in English | MEDLINE | ID: mdl-18313007

ABSTRACT

Recent developments in clinical radiology have resulted in additional developments in the field of forensic radiology. After implementation of cross-sectional radiology and optical surface documentation in forensic medicine, difficulties in the validation and analysis of the acquired data was experienced. To address this problem and for the comparison of autopsy and radiological data a centralized database with internet technology for forensic cases was created. The main goals of the database are (1) creation of a digital and standardized documentation tool for forensic-radiological and pathological findings; (2) establishing a basis for validation of forensic cross-sectional radiology as a non-invasive examination method in forensic medicine that means comparing and evaluating the radiological and autopsy data and analyzing the accuracy of such data; and (3) providing a conduit for continuing research and education in forensic medicine. Considering the infrequent availability of CT or MRI for forensic institutions and the heterogeneous nature of case material in forensic medicine an evaluation of benefits and limitations of cross-sectional imaging concerning certain forensic features by a single institution may be of limited value. A centralized database permitting international forensic and cross disciplinary collaborations may provide important support for forensic-radiological casework and research.


Subject(s)
Autopsy , Databases, Factual , Internet , Tomography, X-Ray Computed , Forms and Records Control , Humans , Image Processing, Computer-Assisted , Magnetic Resonance Imaging , User-Computer Interface
9.
Eur Spine J ; 17(5): 686-90, 2008 May.
Article in English | MEDLINE | ID: mdl-18259784

ABSTRACT

Lumbar spinal stenosis is a frequent indication for spinal surgery. The predictive quality of treadmill testing and MRI for diagnostic verification is not yet clearly defined. Aim of the current study was to assess correlations between treadmill testing and MRI findings in the lumbar spine. Twenty-five patients with lumbar spinal stenosis were prospectively examined. Treadmill tests were performed and the area of the dural sac and neuroforamina was examined with MRI for the narrowest spinal segment. VAS and ODI were used for clinical assessment. The median age of the patients was 67 years. In the narrowest spinal segment the median area of the dural sac was 91 mm(2). The median ODI was 66 per cent. The median walking distance in the treadmill test was 70 m. The distance reached in the treadmill test correlated with the area of the dural sac (Spearman's rho = 0.53) and ODI (rho = -0.51), but not with the area of the neuroforamina and VAS. The distance reached in the treadmill test predicts the grade of stenosis in MRI but has a limited diagnostic importance for the level of clinical symptoms in lumbar spinal stenosis.


Subject(s)
Exercise Test , Lumbar Vertebrae/pathology , Spinal Stenosis/diagnosis , Walking/physiology , Aged , Female , Humans , Lumbar Vertebrae/physiopathology , Magnetic Resonance Imaging , Male , Middle Aged , Spinal Stenosis/pathology , Spinal Stenosis/physiopathology
10.
Pain ; 136(1-2): 62-74, 2008 May.
Article in English | MEDLINE | ID: mdl-17707588

ABSTRACT

The objectives of this study were to develop and validate a tool for assessing pain in population-based observational studies and to develop three subscales for back/neck, upper extremity and lower extremity pain. Based on a literature review, items were extracted from validated questionnaires and reviewed by an expert panel. The initial questionnaire consisted of a pain manikin and 34 items relating to (i) intensity of pain in different body regions (7 items), (ii) pain during activities of daily living (18 items) and (iii) various pain modalities (9 items). Psychometric validation of the initial questionnaire was performed in a random sample of the German-speaking Swiss population. Analyses included tests for reliability, correlation analysis, principal components factor analysis, tests for internal consistency and validity. Overall, 16,634 of 23,763 eligible individuals participated (70%). Test-retest reliability coefficients ranged from 0.32 to 0.97, but only three coefficients were below 0.60. Subscales were constructed combining four items for each of the subscales. Item-total coefficients ranged from 0.76 to 0.86 and Cronbach's alpha were 0.75 or higher for all subscales. Correlation coefficients between subscales and three validated instruments (WOMAC, SPADI and Oswestry) ranged from 0.62 to 0.79. The final Pain Standard Evaluation Questionnaire (SEQ Pain) included 28 items and the pain manikin and accounted for the multidimensionality of pain by assessing pain location and intensity, pain during activity, triggers and time of onset of pain and frequency of pain medication. It was found to be reliable and valid for the assessment of pain in population-based observational studies.


Subject(s)
Pain Measurement/methods , Pain Measurement/standards , Pain/diagnosis , Population Groups , Adolescent , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Pain/epidemiology , Pain/psychology , Pain Measurement/psychology , Population Groups/psychology , Surveys and Questionnaires/standards
11.
Eur Spine J ; 15(11): 1687-94, 2006 Nov.
Article in English | MEDLINE | ID: mdl-16715307

ABSTRACT

This article reports about the internet based, second multicenter study (MCS II) of the spine study group (AG WS) of the German trauma association (DGU). It represents a continuation of the first study conducted between the years 1994 and 1996 (MCS I). For the purpose of one common, centralised data capture methodology, a newly developed internet-based data collection system ( http://www.memdoc.org ) of the Institute for Evaluative Research in Orthopaedic Surgery of the University of Bern was used. The aim of this first publication on the MCS II was to describe in detail the new method of data collection and the structure of the developed data base system, via internet. The goal of the study was the assessment of the current state of treatment for fresh traumatic injuries of the thoracolumbar spine in the German speaking part of Europe. For that reason, we intended to collect large number of cases and representative, valid information about the radiographic, clinical and subjective treatment outcomes. Thanks to the new study design of MCS II, not only the common surgical treatment concepts, but also the new and constantly broadening spectrum of spine surgery, i.e. vertebro-/kyphoplasty, computer assisted surgery and navigation, minimal-invasive, and endoscopic techniques, documented and evaluated. We present a first statistical overview and preliminary analysis of 18 centers from Germany and Austria that participated in MCS II. A real time data capture at source was made possible by the constant availability of the data collection system via internet access. Following the principle of an application service provider, software, questionnaires and validation routines are located on a central server, which is accessed from the periphery (hospitals) by means of standard Internet browsers. By that, costly and time consuming software installation and maintenance of local data repositories are avoided and, more importantly, cumbersome migration of data into one integrated database becomes obsolete. Finally, this set-up also replaces traditional systems wherein paper questionnaires were mailed to the central study office and entered by hand whereby incomplete or incorrect forms always represent a resource consuming problem and source of error. With the new study concept and the expanded inclusion criteria of MCS II 1, 251 case histories with admission and surgical data were collected. This remarkable number of interventions documented during 24 months represents an increase of 183% compared to the previously conducted MCS I. The concept and technical feasibility of the MEMdoc data collection system was proven, as the participants of the MCS II succeeded in collecting data ever published on the largest series of patients with spinal injuries treated within a 2 year period.


Subject(s)
Internet , Lumbar Vertebrae/injuries , Thoracic Vertebrae/injuries , Adolescent , Adult , Aged , Aged, 80 and over , Austria , Child , Data Collection/legislation & jurisprudence , Data Collection/methods , Germany , Humans , Middle Aged , Prospective Studies
12.
BMJ ; 328(7445): 934-8, 2004 Apr 17.
Article in English | MEDLINE | ID: mdl-15087341

ABSTRACT

PROBLEM: A suspected high proportion of unnecessary blood transfusions occur in patients undergoing total joint replacement. DESIGN: Prospective before and after study evaluating the impact of a one page flow chart aimed at reducing the use of blood transfusions. SETTING: Orthopaedic tertiary care centre in Winterthur, Switzerland. 208 patients underwent primary total joint replacement of hips or knees during the control period (October 1998 to September 1999) and 217 during the intervention period (October 1999 to September 2000). KEY MEASURES FOR IMPROVEMENT: Proportion of patients receiving allogeneic blood transfusions. STRATEGIES FOR CHANGE: A simple one page flow chart, which summarised graphically the perioperative decision pathways for anaemic patients, was placed in all charts of patients undergoing total joint replacement and handed out to medical staff from 4 October 1999 onwards. The implementation of the flow chart focused on its endorsement by chief physicians and the development of a sense of "ownership" among physicians and nurses. EFFECTS OF CHANGE: The proportion of patients receiving allogeneic blood decreased from 35.0% to 19.8% (absolute difference -15.2%, 95% confidence interval -23.3 to -7.0%). The percentage of patients donating and receiving autologous blood also decreased. This led to overall savings of about 23,000 pounds sterling (42,470 dollars; 34,441 euros) (103.50 pounds sterlingper patient undergoing total joint replacement). Differences became more pronounced after adjustment for confounding factors. LESSONS LEARNT: Allogeneic blood transfusions in primary hip and knee replacement surgery may be reduced cost effectively by implementing a one page flow chart. Five key elements may have contributed: simplicity; wide distribution; no requirement for major changes; endorsement by local opinion leaders; and development of a sense of ownership. These elements may be used in other contexts to achieve sustained change of clinical practice.


Subject(s)
Algorithms , Arthroplasty, Replacement, Hip , Arthroplasty, Replacement, Knee , Blood Transfusion, Autologous/methods , Aged , Blood Loss, Surgical , Decision Trees , Female , Health Services Misuse , Humans , Male , Prospective Studies , Switzerland
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