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1.
Article in English | MEDLINE | ID: mdl-38866131

ABSTRACT

OBJECTIVE: This study aimed to assess whether a specific adjustable compression garment (ACG) system (Coolflex Standard Calf and Coolflex Standard Foot; Sigvaris Inc.) promotes self care in patients with chronic leg oedema. Secondary aims were to assess the effectiveness of this ACG in reducing oedema, improving patient reported outcomes, and determining the patients' degree of satisfaction with the handling of the wrap. METHODS: This was a multicentre prospective observational study. The study included 99 adult patients aged between 18 and 90 years presenting with chronic oedema of the lower extremity, which encompasses conditions such as lymphoedema, venous oedema, and phlebolymphoedema. At baseline, all patients received an ACG. After two to three days and after six weeks, their overall satisfaction with the therapy was assessed. Leg volume was determined in a contactless manner during the baseline and follow up visits. All patients completed the cross-cultural adaptation of the Lymphoedema Functioning, Disability and Health Questionnaire for Patients with Lymphoedema of the Lower Extremity in Germany (Lymph-ICF-UG). RESULTS: A total of 86 patients completed the study and were followed up for six weeks. At the final six week follow up , 82 (95.3%) of the 86 subjects indicated that they were able to put on the wrap independently or with a little help from relatives. The overall satisfaction rate was 88.5% (95% confidence interval [CI], 80.4 - 94.1%). The mean leg volume reduction from baseline to six weeks was -4.7% (95% CI -6.3 - -3.0%; p < .001). Lymph-ICF-UG scores and scores in all domains improved significantly from baseline to the final follow up. CONCLUSION: The ACG used in this study was found to promote self care in a high proportion of patients with chronic leg oedema. A significant reduction in oedema was observed.

2.
Sci Rep ; 14(1): 3837, 2024 02 15.
Article in English | MEDLINE | ID: mdl-38360840

ABSTRACT

This study analyzed the migration of a calcar-guided short stem to determine the course of very early migration, as well as evaluated the effect of an additional calcium phosphate (CP) coating on a titanium plasma spray (TPS) coating, which has not been analyzed previously. Sixty patients were enrolled in this study and were treated with the A2 calcar-guided short stem. The implant coating was randomized with either the TPS or an additional CP coating, and radiostereometric analysis was performed with the baseline measurement before initial weight-bearing, along with follow-up examinations at 1 week, 6 weeks, 3 months, and 6 months. Implant migrations were 0.27 mm (standard deviation [SD], 0.13 mm) and 0.74 mm (SD, 1.11 mm) at 1 week and 6 months post-surgery, respectively, and 65% and 87% of the implants reached their final position 1 week and 6 weeks after surgery, respectively. After 6 weeks, 3 months, and 6 months, a significant increase was noted in the migration of the CP coating group vs. that of the TPS coating group. Upon the final observation at 6 months, the groups displayed on average a 0.74-mm migration. Most of the analyzed implants ceased migration within the first week post-surgery, but the CP coating demonstrated a higher and more prolonged migration compared to the TPS coating.


Subject(s)
Calcium Phosphates , Early Ambulation , Humans , Prostheses and Implants , Titanium/therapeutic use , Coated Materials, Biocompatible
3.
J Orthop Surg Res ; 18(1): 918, 2023 Dec 02.
Article in English | MEDLINE | ID: mdl-38041115

ABSTRACT

BACKGROUND: Patients with preoperative anemia have a higher risk of requiring blood transfusion after major orthopedic surgery due to increased blood loss and closer transfusion thresholds. Various patient blood management (PBM) policies aim to reduce transfusion rates. This observational study aimed to investigate blood loss and evaluate the effectiveness of an adjusted surgical PBM protocol in patients with anemic chronic disease (ACD) undergoing elective total knee arthroplasty (TKA). METHODS: A consecutive cohort of patients underwent elective unilateral TKA with an adjusted PBM protocol. The protocol consisted of epoetin (EPO) alfa therapy prescribed by the surgeon, routine administration of tranexamic acid (TXA), and standardized postoperative pharmacologic prophylaxis for thromboembolism. The performance of this PBM protocol was analyzed in patients with a baseline hemoglobin level of less than 12 g/dl. Hemoglobin levels were controlled at admission, on postoperative day (POD) 1, and on POD 7 ± 1. A bleeding index (BI-7) was used as an estimate of blood loss up until POD 7. Multiple linear regression was used to assess whether there were any differences in BI-7 between ACD- and ACD + patients. RESULTS: A total of 751 patients with complete hemoglobin monitoring were included in the study. Of these patients, 68 (9.1%) had a baseline hemoglobin concentration of less than 12 g/dl (ACD group). In this group, 28 patients (41.2%) received preoperative EPO therapy. The mean adjusted BI-7 for the study population was 3.0 (95% CI, 2.9 to 3.0) g/dl in the ACD- group and 2.3 (95% CI, 2.0-2.6) g/dl in the ACD + group. The difference in BI-7 was statistically significant (difference, 0.6 [95% CI: 0.3 to 0.9] g/dl, p < 0.001). No major complications occurred in the ACD + group, whereas there were three complications in the ACD- group (p = 1.00). CONCLUSIONS: ACD patients undergoing TKA did not have an increased risk of bleeding or bleeding complications with the use of the adjusted PBM protocol. None of ACD patients required transfusion. ACD patients undergoing TKA experienced significantly less blood loss than patients with no preoperative anemia with the use of the adjusted PBM. We now consider the use of EPO in ACD patients with no nutritional deficiencies undergoing TKA at a baseline hemoglobin level of 11 g/dl. However, this should be validated in larger cohorts with a higher prevalence of ACD patients.


Subject(s)
Anemia , Antifibrinolytic Agents , Arthroplasty, Replacement, Knee , Tranexamic Acid , Humans , Arthroplasty, Replacement, Knee/adverse effects , Arthroplasty, Replacement, Knee/methods , Antifibrinolytic Agents/therapeutic use , Blood Loss, Surgical/prevention & control , Anemia/etiology , Anemia/drug therapy , Tranexamic Acid/therapeutic use , Blood Transfusion , Hemoglobins/analysis , Retrospective Studies , Observational Studies as Topic
4.
Sci Rep ; 13(1): 12597, 2023 08 03.
Article in English | MEDLINE | ID: mdl-37537231

ABSTRACT

Pseudarthrosis following transforaminal interbody fusion (TLIF) is not infrequent. Although cage migration and subsidence are commonly regarded as evidence of the absence of solid fusion, there is still no evidence of the influence of cage migration and subsidence on fusion. This study aimed to evaluate cage migration and subsidence using computed tomography (CT) DICOM data following lumbar interbody fusion. The effects of cage migration and subsidence on fusion and clinical outcomes were also assessed. A postoperative CT data set of 67 patients treated with monosegmental TLIF was analyzed in terms of cage position. To assess the effects of cage migration and subsidence on fusion, 12-month postoperative CT scans were used to assess fusion status. Clinical evaluation included the visual analog scale for pain and the Oswestry Disability Index. Postoperative cage migration occurred in 85.1% of all patients, and cage subsidence was observed in 58.2%. Radiological signs of pseudarthrosis was observed in 7.5% of the patients Neither cage migration nor subsidence affected the clinical or radiographic outcomes. No correlation was found between clinical and radiographic outcomes. The incidence of cage migration was considerable. However, as cage migration and subsidence were not associated with bony fusion, their clinical significance was considered limited.


Subject(s)
Pseudarthrosis , Spinal Fusion , Humans , Treatment Outcome , Lumbar Vertebrae/diagnostic imaging , Lumbar Vertebrae/surgery , Pseudarthrosis/diagnostic imaging , Pseudarthrosis/etiology , Retrospective Studies , Spinal Fusion/adverse effects , Spinal Fusion/methods
5.
J Orthop Surg Res ; 16(1): 697, 2021 Nov 27.
Article in English | MEDLINE | ID: mdl-34838063

ABSTRACT

BACKGROUND: Renal patients are at high risk of blood transfusion following major orthopaedic surgery. A variety of patient blood management (PBM) policies have been proposed to reduce the rate of transfusions. The aim of this observational study was to assess the performance of an adjusted PBM protocol in patients with chronic kidney disease (CKD) undergoing elective total hip arthroplasty (THA). METHODS: A total of 1191 consecutive patients underwent elective unilateral THA and took part in an adjusted PBM protocol. The PBM protocol consisted of epoetin (EPO) alfa therapy prescribed by the surgeon, routine administration of tranexamic acid (TXA), an avascular approach to the hip and postoperative prophylaxis of thromboembolism. The performance of this PBM protocol was analysed in patients with a glomerular filtration rate (GFR) below or above 60 ml/min/1.73 m2 at baseline. Haemoglobin levels were controlled at admission, on postoperative day (POD) 1 and on POD 7 ± 1. A bleeding index (BI) was used as a proxy for blood loss. RESULTS: In total, 153 patients (12.9%) presented with a modification of diet in renal disease value below 60 at baseline. Of these, 20 (13.1%) received EPO therapy and 120 (78.4%) received TXA. None of the patients received allogenic blood transfusions during the first perioperative week. The mean BI for the entire study population was 2.7 (95% CI 2.6, 2.8). CKD did not exert a significant impact on the BI (p = 0.287). However, it was found that both TXA and EPO therapy significantly lowered the BI (difference, - 0.3, p < 0.001). There were no thromboembolic complications in renal patients who received TXA and/or EPO therapy. CONCLUSIONS: A zero-percent transfusion rate during the first perioperative week is attainable in patients with stage 3 or stage 4 CKD undergoing contemporary elective THA. With the use of a pragmatic blood-sparing protocol, patients with renal dysfunction did not have an increased risk of bleeding and did not have an increased incidence in the rate of perioperative blood transfusions.


Subject(s)
Antifibrinolytic Agents/therapeutic use , Arthroplasty, Replacement, Hip , Blood Transfusion , Renal Insufficiency, Chronic/complications , Thromboembolism/prevention & control , Tranexamic Acid/therapeutic use , Aged , Aged, 80 and over , Arthroplasty, Replacement, Hip/adverse effects , Blood Loss, Surgical , Cohort Studies , Female , Humans , Male , Middle Aged , Renal Insufficiency, Chronic/epidemiology
6.
Cureus ; 13(9): e18054, 2021 Sep.
Article in English | MEDLINE | ID: mdl-34692283

ABSTRACT

Introduction A significant percentage of patients require re-revision surgery regardless of the demonstrated durable short- and mid-term clinical results using metaphyseal sleeves in revision total knee arthroplasty (TKA). The aim of this study was to identify the association between sleeve alignment and contact zones, with loosening in patients with revision TKA. Materials & Methods Of a series of 103 patients who underwent revision TKA, at a mean follow-up of eight years, six patients were re-revised for tibial loosening. These patients were compared with 19 unrevised control subjects in a 1:3 ratio. We calculated and compared the cumulative number of contact zones between the porous-coated part of the sleeve and bone on immediate postoperative X-rays between re-revised and unrevised patients. The main hypothesis was that neutral positioning and absolute circumferential contact between trabecular metaphyseal bone and porous-coated part of the sleeve would lead to a better outcome. Results The use of a conservative (nonparametric) approach indeed revealed better circumferential contact between trabecular metaphyseal bone and porous-coated part of the sleeve among the survivors, i.e., survivors: median (interquartile range [IQR]): 3 (2-4); failures: 3 (1-3), p = 0.003 (Mann-Whitney [MW] test). The difference was borderline significant for coronal alignment, i.e., survivors: median (IQR): -1 (-4 to 2); failures: 0 (-1 to 3), p = 0.0569 (MW test). Conclusion A circumferential bony contact of the metaphyseal sleeve would lead to better survival of the revision implant, whereas the degree of varus fixation did not seem to influence the longevity of the implant.

7.
Sci Rep ; 10(1): 16094, 2020 09 30.
Article in English | MEDLINE | ID: mdl-32999385

ABSTRACT

The study investigated whether the use of carbon fiber-reinforced PEEK screw material (CF-PEEK) can reduce magnetic resonance imaging (MRI) artifact formation. Two consecutive groups of patients were treated for degenerative spinal disorders of the lumbar spine with dorsal transpedicular spinal fusion. The first group (n = 27) received titanium pedicle screws. The second group (n = 20) received CF-PEEK screws. All patients underwent an MRI assessment within the first four postoperative weeks. For each operated segment, the surface of the artifact-free vertebral body area was calculated as percentage of the total vertebral body. For each implanted segment, the assessability of the spinal canal, the neuroforamina, and the pedicle screws, as well as the surrounding bony and soft-tissue structures was graded from 1 to 5. A mean artifact-free vertebral body area of 48.3 ± 5.0% was found in the in the titanium group and of 67.1 ± 5.6% in the CF-PEEK group (p ≤ 0.01). Assessability of the lumbar spine was significantly improved for CF-PEEK screws (p ≤ 0.01) for all measurements. CF-PEEK pedicle screws exhibit smaller artifact areas on vertebral body surfaces and their surrounding tissues, which improves the radiographic assessability. Hence, CF-PEEK may provide a diagnostic benefit.


Subject(s)
Carbon Fiber , Magnetic Resonance Imaging/methods , Pedicle Screws , Spinal Fusion/instrumentation , Adult , Aged , Aged, 80 and over , Artifacts , Benzophenones , Biocompatible Materials , Cross-Sectional Studies , Equipment Design , Female , Humans , Ketones , Lumbar Vertebrae/diagnostic imaging , Lumbar Vertebrae/surgery , Male , Middle Aged , Polyethylene Glycols , Polymers , Retrospective Studies , Spinal Diseases/diagnostic imaging , Spinal Diseases/surgery , Titanium
8.
Orthopade ; 49(7): 562-569, 2020 Jul.
Article in German | MEDLINE | ID: mdl-32494903

ABSTRACT

INTRODUCTION: Mechanical alignment (MA) is a standardized procedure that aims to achieve a neutrally aligned leg axis. An alignment of the prosthesis closer to the patient's anatomy can be an approach for better clinical outcomes. The surgical technique of adjusted mechanical alignment (aMA) presented here is a modified extension-gap-first technique that takes into account the natural ligamentous tension of the knee joint so that ligamentous releases can be avoided as far as possible. INDICATION: The aMA technique can be used for primary and secondary varus gonarthrosis of up to 20° of varus. SURGICAL TECHNIQUE: The aim of the operation is to achieve a balanced ligament tension through a femoral osseous correction rather than ligament releases. TEA and the sulcus line are marked to control the ligament-based femoral rotation. The osteophytes are removed to ensure a reliable ligament tension. A quantitative ligament tensioner is stretched with great care, and gap width as well as medial and lateral ligament tension are read off. In order to correct an extension gap asymmetry, instead of the typical medial soft tissue release, the asymmetry is compensated by a special femoral cutting block. Now, the flexion gap is assessed, whereby the transverse femoral rotation follows the soft tissue tension. The tensioner adjusts a rectangular flexion gap with balanced ligament tension. After a final balancing of the gaps, the femoral preparation is completed and the trial components are inserted. Here, the rotation of the tibial component is set by repeated flexion-extension cycles. DISCUSSION AND CONCLUSION: The technique presented combines a measured-resection technique with individual ligament tension. The maximum deviation of the femoral alignment in the coronal plane from the neutral alignment is 2.5°. In order to avoid problems, it is recommended, as with the described technique, to achieve a component alignment based on the patient anatomy by adjusting the femoral component. The measured-resection technique carries the risk of flexion instability. With the gap-balancing technique symmetrical ligament tension can be achieved, assuming precise proximal tibial cuts. When aligning the femoral component rotation, flexion gap stability and patella tracking should be considered. Long-term studies of high case numbers are necessary to evaluate the good short-term results of the presented surgical technique.


Subject(s)
Arthroplasty, Replacement, Knee , Knee Joint/surgery , Knee Prosthesis , Femur , Humans , Range of Motion, Articular , Tibia
9.
BMC Musculoskelet Disord ; 21(1): 23, 2020 Jan 11.
Article in English | MEDLINE | ID: mdl-31926561

ABSTRACT

BACKGROUND: With ever-increasing numbers of patients undergoing elective total knee arthroplasty (TKA) and as TKA is performed in increasingly younger patients, patient demands and expectations have also increased. With improved patient outcomes, new PROMs with heightened discriminatory power in well-performing patients are needed. The present study aimed to translate and validate the Italian version of the Forgotten Joint Score (FJS-12) as a tool for evaluating pre-operative through longitudinal post-operative outcomes in an Italian population. METHODS: In this prospective study, patients with unilateral osteoarthritis, undergoing TKA surgery between May 2015 and December 2017 were recruited to participate in the study. The FJS-12 and WOMAC were collected pre-operatively and at six and 12 months post-operatively. According to the COSMIN checklist, reliability, internal consistency, validity, responsiveness, effect size, and ceiling effects and floor effects were evaluated. RESULTS: One hundred twenty patients completed the study, 66 of which participated in the evaluation of test-retest reliability. Good test-retest reliability was found (ICC = 0.90). The FJS-12 also showed excellent internal consistency (Cronbach α = 0.81). Construct validity with the WOMAC, as a measure of the Pearson correlation coefficient, was moderate (r = 0.45 pre-operatively; r = 0.46 at 6 months and r = 0.42 at 12 months post-operatively). From six to 12 months, the change was slightly greater for the WOMAC than for the FJS-12 patients (effect size d = 0.94; d = 0.75, respectively). At 12-months follow-up, the ceiling effects reflecting the maximum score were 12% for the FJS-12 and 6% for the WOMAC; however, scores within 10% of the maximum score were comprised 30% of the FJS-12 scores and 59% for the WOMAC. CONCLUSION: The Italian FJS-12 demonstrated strong measurement properties in terms of reliability, internal consistency, and construct validity in TKA patients. Furthermore, a more detailed look at ceiling effects shows a superior discriminatory capacity when compared to the WOMAC at 12-months follow-up, particularly in better-performing patients. TRIAL REGISTRATION: clinicaltrials.gov NCT03805490. Registered 18 January 2019 (retrospectively registered).


Subject(s)
Arthroplasty, Replacement, Knee , Outcome Assessment, Health Care , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Prospective Studies , Reproducibility of Results , Translating
10.
Bone Joint J ; 102-B(1): 132-136, 2020 Jan.
Article in English | MEDLINE | ID: mdl-31888367

ABSTRACT

AIMS: We report the natural course of Baker's cysts following total knee arthroplasty (TKA) at short- and mid-term follow-up. METHODS: In this prospective case series, 105 TKA patients were included. All patients who received surgery had a diagnosis of primary osteoarthritis and had preoperatively presented with a Baker's cyst. Sonography and MRI were performed to evaluate the existence and the gross size of the cyst before TKA, and sonography was repeated at a mean follow-up time of 1.0 years (0.8 to 1.3; short-term) and 4.9 years (4.0 to 5.6; mid-term) after TKA. Symptoms potentially attributable to the Baker's cyst were recorded at each assessment. RESULTS: At the one-year follow-up analysis, 102 patients were available. Of those, 91 patients were available for the 4.9-year assessment (with an 86.7% follow-up rate (91/105)). At the short- and mid-term follow-up, a Baker's cyst was still present in 87 (85.3%) and 30 (33.0%) patients, respectively. Of those patients who retained a Baker's cyst at the short-term follow-up, 31 patients (35.6%) had popliteal symptoms. Of those patients who continued to have a Baker's cyst at the mid-term follow-up, 17 patients (56.7%) were still symptomatic. The mean preoperative cyst size was 14.5 cm2 (13.1 to 15.8). At the short- and mid-term follow-up, the mean cyst size was 9.7 cm2 (8.3 to 11.0) and 10.4 cm2 (9.8 to 11.4), respectively. A significant association was found between the size of the cyst at peroperatively and the probability of resolution, with lesions smaller than the median having an 83.7% (36/43) probability of resolution, and larger lesions having a 52.1% (25/48) probability of resolution (p < 0.001). At the mid-term follow-up, no association between cyst size and popliteal symptoms was found. CONCLUSION: At a mean follow-up of 4.9 years (4.0 to 5.6) after TKA, the majority (67.0%, 61/91) of the Baker's cysts that were present preoperatively had disappeared. The probability of cyst resolution was dependent on the size of the Baker's cyst at baseline, with an 83.7% (36/43) probability of resolution for smaller cysts and 52.1% (25/48) probability for larger cysts. Cite this article: Bone Joint J. 2020;102-B(1):132-136.


Subject(s)
Arthroplasty, Replacement, Knee/methods , Popliteal Cyst/pathology , Aged , Aged, 80 and over , Female , Follow-Up Studies , Humans , Magnetic Resonance Imaging , Male , Middle Aged , Osteoarthritis, Knee/pathology , Osteoarthritis, Knee/surgery , Popliteal Cyst/surgery , Prospective Studies , Treatment Outcome , Ultrasonography
11.
Int Orthop ; 44(2): 261-266, 2020 02.
Article in English | MEDLINE | ID: mdl-31468111

ABSTRACT

PURPOSE: Pre-operative anaemia treatment has been associated with reduced morbidity in joint arthroplasty. This study examined the impact of a surgical prescription of epoetin (EPO) in contemporary total hip arthroplasty (THA). METHODS: We conducted a comparative study in a series of 1402 primary THAs performed in patients all having a pre-operative haemoglobin (Hb) level documented four to eight  weeks before THA surgery. In group A (647 hips), one subcutaneous injection of 40,000 IU EPO once a week for four weeks was prescribed at the discretion of anaesthetist during the pre-operative visit in patients with pre-operative Hb between 10 and 13 g/dl. In group S comprising the remaining 755 hips, an amended EPO therapy including two  injections of 20,000 to 40,000 IU was prescribed by the surgeon in patients with Hb less than 12 g/dl deemed at high risks to be transfused following THA. Primary study endpoint was the bleeding index (BI). RESULTS: EPO therapy was delivered in 43 patients (6.7%) in group A and in 26 patients (3.4%) in group S (p = 0.006). The mean total dose of EPO administrated was 115,349 IU in group A versus 75,200 IU in group S (p < 0.001). The mean BI were 2.7 ± 1.0 in group A and 2.8 ± 1.0 g/dl in group S (p = 0.375). No patient was blood-transfused up to post-operative day seven in group S versus five patients in group A (p = 0.021). CONCLUSIONS: The amended protocol does not lead to increased peri-operative bleeding. Advances in intra-operative methods to reduce the bleeding allow changing indications of EPO in patients undergoing THA with a low level of Hb.


Subject(s)
Anemia/drug therapy , Arthroplasty, Replacement, Hip , Epoetin Alfa/administration & dosage , Hematinics/administration & dosage , Joint Diseases/surgery , Middle Aged , Administration, Oral , Aged , Aged, 80 and over , Anemia/complications , Anemia/therapy , Arthroplasty, Replacement, Hip/adverse effects , Blood Transfusion , Female , Humans , Injections, Subcutaneous , Iron Compounds/administration & dosage , Joint Diseases/complications , Male , Prospective Studies
12.
Eur J Orthop Surg Traumatol ; 29(6): 1187-1197, 2019 Aug.
Article in English | MEDLINE | ID: mdl-30993521

ABSTRACT

PURPOSE: This case series reports on the efficacy and safety of a less invasive posterolateral approach for septic thoracolumbosacral spondylodiscitis in high-morbidity patients. METHODS: Twenty consecutive severe sick (ASA > III) patients (14 men and 6 women), with an average age of 64 ± 14 years, suffering from septic subacute and chronic thoracolumbosacral spondylodiscitis were selected to undergo a one-stage less invasive unilateral posterolateral disc space debridement, supplemented by an ipsilateral titanium cage implantation and pedicle screw fixation plus a contralateral transfascial pedicle screw fixation. RESULTS: Two high-risk patients with severe comorbidities (ASA stage IV and V, respectively) died on days 1 and 8 postoperatively because of non-surgical complications such as massive lung embolism and acute myocardial infract, respectively. Three patients with incomplete paraplegia (ASIA C) preoperatively were improved after the surgery to ASIA D (two patients) and E (one patient), respectively, while there was no neurological deterioration in any patient postoperatively. From the 18 patients that survived, ten patients were available for the final follow-up 8.8 ± 2.7 years postoperatively. In two patients with spondylodiscitis caused by gram(-) bacteria, the posterior instrumentation was finally removed because of asymptomatic fistula emerging from posterior instrumentation solely, 15 and 19 months after surgery. The survivals at 2.5 and 10 years with revision as end point was 87.4% (95% CI 58.1-96.7); while in the "worst case scenario" the survivals at 2.5 and 10 years were: 66.7% (95% CI 40.4-83.4%); 47.7% (95% CI 23.2-68.8%) and 47.7% (95% CI 23.2-68.8%), respectively. CONCLUSIONS: The less invasive posterolateral approach for disc debridement and titanium cage insertion seems to be an alternative surgery for severe sick adult immunosuppressed patients with septic thoracolumbosacral spondylodiscitis that cannot tolerate traditional open transthoracic, thoracolumbar, retroperitoneal or combined approaches. The study has been registered in the Public Registry ClinicalTrials.gov PRS with the ID: NCT03472131.


Subject(s)
Debridement/methods , Discitis , Lumbar Vertebrae/surgery , Sacrum/surgery , Spinal Fusion , Thoracic Vertebrae/surgery , Aged , Chronic Disease , Discitis/diagnostic imaging , Discitis/pathology , Discitis/surgery , Female , Humans , Male , Middle Aged , Outcome and Process Assessment, Health Care , Pedicle Screws , Radiography/methods , Severity of Illness Index , Spinal Fusion/instrumentation , Spinal Fusion/methods
13.
Adv Orthop ; 2018: 1623647, 2018.
Article in English | MEDLINE | ID: mdl-30174959

ABSTRACT

PURPOSE: A retrospective study that aims to report Adjacent Segment Degeneration (ASD) incidence and spinopelvic balance in short lumbosacral instrumentation for degenerative lumbar spinal stenosis. Although ASD is a common complication following lumbar fusion, the effect of an interspinous spacer (IS) in the supradjacent segment in short lumbosacral instrumented fusion and its interaction with spinopelvic balance has not been studied adequately. METHODS: From 55 consecutive age-, diagnosis-, and gender-matched patients aged 60±11 years, 17 (Group R) received PEEK IS; 18 (Group S) received Silicon IS compared with 20 controls (Group C) without receiving any IS. The functional outcome was evaluated with VAS and ODI. Spinopelvic balance was evaluated using SVA, T12-S1 LL, SS, PT, PI, and supradjacent segment disc heights. All spines were preoperatively balanced (SVA<40 mm). RESULTS: The follow-up averaged out to 56±11 months. VAS and ODI scores improved postoperatively in all 3 groups. SS and anterior disc height in the supradjacent free segment increased postoperatively compensatory to spinal alterations. Although 6, 4, and 5 patients from Groups R, S, and C, respectively, showed radiological progression of the preoperative degeneration grade in the supradjacent disc, only 2, 1, and 2 patients in Groups R, S, and C, respectively, developed symptomatic ASD in the 1st supradjacent segment solely. No additional surgery was required in any patient. CONCLUSION: ASD incidence in the supradjacent segment following short lumbar fusion did not statistically significantly differ between PEEK and Silicon IS. There was a trend towards lower ASD incidence in Silicon IS. IS reduced ASD in both 1st and 2nd supradjacent segments. The authors speculate that soft stabilization provided by IS may be more advantageous for preventing ASD. This trial is registered with ClinicalTrials.govNCT03477955.

14.
Spine Deform ; 6(5): 514-522, 2018.
Article in English | MEDLINE | ID: mdl-30122386

ABSTRACT

STUDY DESIGN: Α series study. OBJECTIVES: To evaluate the relationships between the effectiveness of brace in reduction of scoliosis angle, axial trunk rotation (ATR), and patients' compliance, in skeletally immature females with moderate adolescent idiopathic scoliosis (AIS), treated with Chêneau brace for a minimum of three years. SUMMARY OF BACKGROUND DATA: According to some authors, braces are ineffective, whereas others find that braces stop scoliosis progression and that the outcome has been related to patient's compliance. METHODS: From the 100 patients who were initially recruited, 88 patients were included in the final analysis. The average ± SD primary scoliosis angle before brace application was 36.8° ± 9.9°, 32.7° ± 6.3°, and 33.5° ± 11.5° for major thoracic, thoracolumbar, and lumbar curvatures, respectively. All patients were aged ≥10 years at treatment initiation, and their Risser index varied from 0 to II. Eighty-eight patients were followed for at least three years with brace treatment, whereas 43 patients were reevaluated 31 ± 7 months after brace weaning. In baseline and while in brace, the scoliosis Cobb angle, Risser index, menarche age, ATR, and patient's compliance were recorded. RESULTS: In the 88 patients, the brace reduced the major thoracic, thoracolumbar, and lumbar scoliosis one month after brace onset while "in brace" to 26° ± 11° (29% ± 18%, p = .0006), 23° ± 8° (31% ± 20%, p = .00001), and 24° ± 11° (34% ± 21%, p = .00043), respectively; thereafter, no significant decrease of the curves was recorded. Total bracing time averaged at 45 ± 19 months (range 36-96) and brace weaning averaged at 17 ± 2 years (range 15-19). Six of the 88 (6.8%) individuals underwent surgery for scoliosis progression. In the 43 patients who were reevaluated 31 ± 7 months after brace weaning, scoliosis angle and ATR increased insignificantly, compared to the three years' values. CONCLUSIONS: Chêneau orthosis reduced while "in brace" AIS in girls with sufficient compliance, with a low rate (6.8%) of patients who underwent surgery. LEVEL OF EVIDENCE: Level 3.


Subject(s)
Braces/adverse effects , Patient Compliance/statistics & numerical data , Rotation/adverse effects , Scoliosis/therapy , Spinal Curvatures/therapy , Adolescent , Age Determination by Skeleton/methods , Cohort Studies , Disease Progression , Female , Follow-Up Studies , Humans , Prospective Studies , Treatment Outcome , Young Adult
15.
Blood Transfus ; 16(1): 44-52, 2018 01.
Article in English | MEDLINE | ID: mdl-27723454

ABSTRACT

BACKGROUND: The effect of tranexamic acid has not been examined in patients who are regular users of antithrombotics before undergoing total knee arthroplasty. The aim of this study was to determine the impact of tranexamic acid on bleeding and the risk of transfusion and thrombosis in patients taking an antithrombotic treatment before primary unilateral total knee arthroplasty. MATERIAL AND METHODS: A prospective observational study was conducted in a series of 385 consecutive primary total knee arthroplasties performed with and without the administration of tranexamic acid. We compared post-operative bleeding, as determined by a bleeding index, and postoperative haemoglobin and haematocrit between patients taking an antithrombotic treatment before the operation (ATT+ group) and those naïve or non-regular users of antithrombotics (ATT- group). Post-operatively, rivaroxaban was prescribed for deep vein thrombosis prophylaxis, unless contraindicated. Antiplatelet therapy and vitamin K antagonist anticoagulants were not resumed during the early post-operative period. RESULTS: The prevalence of total knee arthroplasty performed in patients who are regular users of antithrombotics was 33%. Tranexamic acid was administered during 62% of the arthroplasties in the ATT+ group and to 90% in the ATT- group. In both study groups, the bleeding index was significantly lower in patients who received tranexamic acid, both in the ATT+ (p<0.001) and in the ATT- group (p=0.001). No patients in the ATT+ group received a blood transfusion during the first post-operative week. No thrombotic complications were identified for up to 2 months in the ATT+ group. DISCUSSION: Tranexamic acid use after the induction of general anaesthesia in total knee arthroplasty represents a fast, inexpensive, and effective opportunity to reduce peri-operative blood loss in patients on chronic antithrombotic treatment undergoing total knee arthroplasty.


Subject(s)
Arthroplasty, Replacement, Knee , Blood Loss, Surgical/prevention & control , Fibrinolytic Agents/administration & dosage , Tranexamic Acid/administration & dosage , Aged , Aged, 80 and over , Fibrinolytic Agents/adverse effects , Humans , Prevalence , Prospective Studies , Risk Factors , Tranexamic Acid/adverse effects , Venous Thrombosis/blood , Venous Thrombosis/prevention & control
16.
Eur J Orthop Surg Traumatol ; 28(5): 959-965, 2018 Jul.
Article in English | MEDLINE | ID: mdl-29167979

ABSTRACT

The current study was designed to determine (1) 10-year implant survival and (2) patient's self-reported functional outcome in a single surgeon's consecutive cohort of patients who had undergone minimally invasive unicondylar resurfacing with a modified cementation technique utilizing a cobalt-chromium femur/inlaid all-PE tibia, fixed-bearing unicompartmental prosthesis. We included 344 consecutive patients (361 knees) who had received the study device between January 2002 and December 2005 in this retrospective study. After 10 years, 78 patients (78 knees) had died, 59 (59 knees) were lost to follow-up and four (four knees) did not participate. Thirteen knees (11 patients) were revised after a mean of 5.8 ± 1.9 years. Hence, the study population at follow-up comprised 192 patients (207 knees). Ten-year implant survival was 94.6% (95% confidence interval, 90.9-96.8%). The Forgotten Joint Score and Oxford Knee Score were 68.9 ± 28.9 and 39 ± 9.1, respectively. Excellent survivorship and clinical outcomes were obtained with UKA with an inlaid all-PE tibia with a modified cementation technique.


Subject(s)
Arthroplasty, Replacement, Knee/rehabilitation , Knee Joint/surgery , Osteoarthritis, Knee/surgery , Aged , Arthroplasty, Replacement, Knee/methods , Bone Cements , Cementation , Female , Follow-Up Studies , Humans , Knee Prosthesis , Male , Middle Aged , Minimally Invasive Surgical Procedures/rehabilitation , Patient Reported Outcome Measures , Prosthesis Failure , Recovery of Function , Retrospective Studies , Treatment Outcome
17.
Knee Surg Sports Traumatol Arthrosc ; 26(4): 1252-1257, 2018 Apr.
Article in English | MEDLINE | ID: mdl-28646381

ABSTRACT

PURPOSE AND HYPOTHESIS: The principal purpose of this paper was to identify whether femoral notch morphology was different in females without anterior cruciate ligament (ACL) injury from those with ACL injury. Magnetic resonance imaging (MRI) was used to assess the femoral notch type, notch width index and 'α angle' in female patients and measure these differences. METHODS: This is a retrospective case control study of 119 female patients, 58 with ACL injury and 61 patients without ACL injury who underwent knee MRI between March 2014 and April 2016. The morphometric measurements were taken by two independent observers. The femoral notch width index was calculated as the ratio between the central notch width and transcondylar or intercondylar width; values >0.27 were considered normal. The femoral notch shape was classified as Type A, Type U or Type W, with Type A describing a stenotic notch, Type U a notch with a wider contour and Type W a wider Type U with two apices apparent. The angle between the longitudinal femoral axis and the Blumensaat line was identified as the 'α angle'. The statistical analysis was performed with t tests, simple and multivariable logistic regression analysis to evaluate the strength of these specific femoral notch morphometric values as predictive factors to ACL rupture. RESULTS: Stenotic femoral notch Type A was identified as a high risk factor to ACL injury (odds ratio [OR] = 2.8; p = 0.03). There was no significant difference between the two groups for the notch width index (OR = 0.7; p = n.s.) and the 'α angle' (OR 1.02; p = n.s.). Significant association between NWI and stenotic notch was found (p < 0.01). CONCLUSIONS: This study showed that Type A stenotic femoral notch can be considered as a valuable predictive factor for ACL injury. Notch width index and 'α angle' are weak indicators in ACL injury prognosis. Ligament impingement may be inferred as an important mechanism in female ACL rupture. Injury prevention strategies, such as prehabilitation programmes, could be introduced in the benefit of young females with stenotic notch. LEVEL OF EVIDENCE: III.


Subject(s)
Anterior Cruciate Ligament Injuries/etiology , Constriction, Pathologic/diagnostic imaging , Femur/diagnostic imaging , Adult , Anterior Cruciate Ligament Injuries/diagnostic imaging , Anterior Cruciate Ligament Injuries/surgery , Case-Control Studies , Constriction, Pathologic/complications , Female , Femur/anatomy & histology , Humans , Magnetic Resonance Imaging/methods , Retrospective Studies , Risk Factors , Young Adult
18.
J Bone Joint Surg Am ; 99(6): 521-530, 2017 Mar 15.
Article in English | MEDLINE | ID: mdl-28291186

ABSTRACT

BACKGROUND: Patient-specific instrumentation (PSI) was introduced with the aim of making the procedure of total knee arthroplasty more accurate and efficient. The purpose of this study was to compare PSI and standard instrumentation in total knee arthroplasty with regard to radiographic and clinical outcomes as well as operative time and blood loss. METHODS: A meta-analysis was conducted in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. PubMed and Embase were searched from 2011 through 2015. We included randomized controlled trials and cohort studies that reported the effect of PSI on the aforementioned outcomes. The primary end point was deviation from the mechanical axis by >3°. Random and fixed-effect models were used for analysis. RESULTS: A total of 44 studies, which included 2,866 knees that underwent surgery with PSI and 2,956 knees that underwent surgery with standard instrumentation, were evaluated. The risk of mechanical axis malalignment was significantly lower for PSI, with a pooled relative risk of 0.79 (p = 0.013). The risk of tibial sagittal-plane malalignment was higher for PSI than for standard instrumentation (relative risk = 1.32, p = 0.001), whereas the risk of femoral coronal-plane malalignment was significantly lower (relative risk = 0.74, p = 0.043). The risk of tibial coronal-plane malalignment was significantly higher for PSI only when employing fixed-effect meta-analysis (relative risk = 1.33, p = 0.042). Minor reductions in total operative time (-4.4 minutes, p = 0.002) and blood loss (-37.9 mL, p = 0.015) were noted for PSI. CONCLUSIONS: PSI improves the accuracy of femoral component alignment and global mechanical alignment, but at the cost of an increased risk of outliers for the tibial component alignment. The impact of the increased probability of tibial component malalignment on implant longevity remains to be determined. Meta-analyses indicated significant differences with regard to operative time and blood loss in favor of PSI. However, these differences were minimal and, by themselves, not a substantial justification for routine use of the technology. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.


Subject(s)
Arthroplasty, Replacement, Knee/methods , Knee Joint/surgery , Knee Prosthesis , Prosthesis Design , Arthroplasty, Replacement, Knee/instrumentation , Humans , Precision Medicine , Treatment Outcome
19.
BMJ Open ; 7(3): e012964, 2017 03 27.
Article in English | MEDLINE | ID: mdl-28348182

ABSTRACT

INTRODUCTION: The proper management of total knee arthroplasty (TKA) in patients with severe deformities regarding the preferable prosthetic design and the required amount of constraint is a controversial subject. In the absence of any high-level clinical evidence, we designed a randomised clinical trial to investigate if rotating hinged (RTH) and constrained condylar knee (CCK) designs yield similar outcomes. METHODS AND ANALYSIS: This study is a multicentre, randomised clinical trial including two groups of 85 patients. Patients will be randomised to a CCK knee design group or an RTH knee design group. Patients will be followed for 2 years. The study will be designed as an equivalence trial. The primary study outcome will be the postoperative functional outcome as measured by the self-administered Knee Injury and Osteoarthritis Outcome Score. Secondary outcomes will be postoperative joint awareness during various activities of daily living as measured by the Forgotten Joint Score-12, the Knee Society Score, along with the incidence and location of radiolucent lines using the Knee Society TKA radiographic evaluation system. ETHICS AND DISSEMINATION: This study is approved by the ethics committee of the Landesärztekammer Brandenburg ((S 10(a)/2013) from 27.08.2013, amended on 25.04.2016) and will be conducted according to the principles of the World Medical Association Declaration of Helsinki and the ISO14155:2011. TRIAL REGISTRATION NUMBER: DRKS00010539.


Subject(s)
Arthroplasty, Replacement, Knee , Joint Instability/surgery , Knee Joint/surgery , Osteoarthritis, Knee/surgery , Postoperative Complications/surgery , Radiography , Reoperation/statistics & numerical data , Activities of Daily Living , Aged , Arthroplasty, Replacement, Knee/adverse effects , Arthroplasty, Replacement, Knee/instrumentation , Arthroplasty, Replacement, Knee/methods , Female , Follow-Up Studies , Germany/epidemiology , Humans , Incidence , Joint Instability/diagnostic imaging , Joint Instability/physiopathology , Knee Joint/diagnostic imaging , Knee Joint/physiopathology , Knee Prosthesis , Male , Osteoarthritis, Knee/diagnostic imaging , Osteoarthritis, Knee/physiopathology , Postoperative Complications/diagnostic imaging , Postoperative Complications/physiopathology , Postoperative Period , Prosthesis Failure , Range of Motion, Articular , Treatment Outcome
20.
Open Orthop J ; 11: 1236-1244, 2017.
Article in English | MEDLINE | ID: mdl-29290862

ABSTRACT

BACKGROUND: There is ongoing debate about how to obtain correct rotational alignment in total knee arthroplasty (TKA). Two commonly used techniques are the measured resection (MR) and the gap balancing (GB) technique. OBJECTIVE: The objective of the present study was to analyze which of these two techniques confers a clinical advantage up to 10 years postoperatively. METHODS: Two hundred patients were randomized to either MR or GB. The primary outcome was the Knee Society Knee Score (KS) 10 years postoperatively. Secondary outcomes were passive range of motion, the Knee Society Function Score (FS), and the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC), along with implant survival. We employed a two one-sided test (TOST) and linear mixed models to assess clinical outcomes. RESULTS: Mean KS was 82 (95% confidence interval (CI), 80 - 83) and 77 (95% CI, 76 - 79) in the GB and MR group, respectively. The TOST test and linear mixed model both revealed statistical significance (p < 0.001). In addition, GB yielded better postoperative FS and WOMAC. However, between-group differences were consistently small. Implant survival rates at 10 years, with survival for any reason as the endpoint of interest, were 93.7% (95% CI, 86.4% and 97.1%) and 89.8% (95% CI, 81.9% - 94.4%) for the GB group and the MR group, respectively (p = 0.302). CONCLUSION: Gap-balancing is a safe and reliable technique. KS for the two study groups at 10 years can be considered equivalent, and the small postoperative advantages may not extend beyond clinical relevance.

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