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1.
Eur Stroke J ; 9(1): 265-273, 2024 Mar.
Article in English | MEDLINE | ID: mdl-37713268

ABSTRACT

BACKGROUND: Inflammation plays a vital role in the development of secondary brain injury after spontaneous intracerebral haemorrhage (ICH). Interleukin-1 beta is an early pro-inflammatory cytokine and a potential therapeutic target. AIM: To determine the effect of treatment with recombinant human interleukin-1 receptor antagonist anakinra on perihematomal oedema (PHO) formation in patients with spontaneous ICH compared to standard medical management, and investigate whether this effect is dose-dependent. METHODS: ACTION is a phase-II, prospective, randomised, three-armed (1:1:1) trial with open-label treatment and blinded end-point assessment (PROBE) at three hospitals in The Netherlands. We will include 75 patients with a supratentorial spontaneous ICH admitted within 8 h after symptom onset. Participants will receive anakinra in a high dose (loading dose 500 mg intravenously, followed by infusion with 2 mg/kg/h over 72 h; n = 25) or in a low dose (loading dose 100 mg subcutaneously, followed by 100 mg subcutaneous twice daily for 72 h; n = 25), plus standard care. The control group (n = 25) will receive standard medical management. OUTCOMES: Primary outcome is PHO, measured as oedema extension distance on MRI at day 7 ± 1. Secondary outcomes include the safety profile of anakinra, the effect of anakinra on serum inflammation markers, MRI measures of blood brain barrier integrity, and functional outcome at 90 ± 7 days. DISCUSSION: The ACTION trial will provide insight into whether targeting interleukin-1 beta in the early time window after ICH onset could ameliorate secondary brain injury. This may contribute to the development of new treatment options to improve clinical outcome after ICH.


Subject(s)
Brain Injuries , Interleukin 1 Receptor Antagonist Protein , Humans , Interleukin-1beta , Interleukin 1 Receptor Antagonist Protein/adverse effects , Neuroinflammatory Diseases , Prospective Studies , Cerebral Hemorrhage/drug therapy , Edema , Randomized Controlled Trials as Topic , Clinical Trials, Phase II as Topic
2.
Osteoarthritis Cartilage ; 31(5): 557-566, 2023 05.
Article in English | MEDLINE | ID: mdl-36646304

ABSTRACT

OBJECTIVE: To identify subgroups of patients with magnetic resonance imaging (MRI)-confirmed degenerative meniscus tears who may benefit from arthroscopic partial meniscectomy (APM) in comparison with non-surgical or sham treatment. METHODS: Individual participant data (IPD) from four RCTs were pooled (605 patients, mean age: 55 (SD: 7.5), 52.4% female) as to investigate the effectiveness of APM in patients with MRI-confirmed degenerative meniscus tears compared to non-surgical or sham treatment. Primary outcomes were knee pain, overall knee function, and health-related quality of life, at 24 months follow-up (0-100). The IPD were analysed in a one- and two-stage meta-analyses. Identification of potential subgroups was performed by testing interaction effects of predefined patient characteristics (e.g., age, gender, mechanical symptoms) and APM for each outcome. Additionally, generalized linear mixed-model trees were used for subgroup detection. RESULTS: The APM group showed a small improvement over the non-surgical or sham group on knee pain at 24 months follow-up (2.5 points (95% CI: 0.8-4.2) and 2.2 points (95% CI: 0.9-3.6), one- and two-stage analysis, respectively). Overall knee function and health-related quality of life did not differ between the two groups. Across all outcomes, no relevant subgroup of patients who benefitted from APM was detected. The generalized linear mixed-model trees did also not identify a subgroup. CONCLUSIONS: No relevant subgroup of patients was identified that benefitted from APM compared to non-surgical or sham treatment. Since we were not able to identify any subgroup that benefitted from APM, we recommend a restrained policy regarding meniscectomy in patients with degenerative meniscus tears.


Subject(s)
Meniscus , Osteoarthritis, Knee , Humans , Middle Aged , Meniscectomy/methods , Quality of Life , Magnetic Resonance Imaging , Pain/etiology , Arthroscopy/methods , Osteoarthritis, Knee/diagnostic imaging , Osteoarthritis, Knee/surgery , Osteoarthritis, Knee/etiology
3.
Ann Surg ; 277(4): e856-e863, 2023 04 01.
Article in English | MEDLINE | ID: mdl-34387199

ABSTRACT

OBJECTIVE: The aim of this study was to develop and validate a clinical prediction model to predict overall survival in patients with nonmetastatic, resected gallbladder cancer (GBC). BACKGROUND: Although several tools are available, no optimal method has been identified to assess survival in patients with resected GBC. METHODS: Data from a Dutch, nation-wide cohort of patients with resected GBC was used to develop a prediction model for overall survival. The model was internally validated and a cohort of Australian GBC patients who underwent resection was used for external validation. The performance of the American Joint Committee on Cancer (AJCC) staging system and the present model were compared. RESULTS: In total, 446 patients were included; 380 patients in the development cohort and 66 patients in the validation cohort. In the development cohort median survival was 22 months (median follow-up 75 months). Age, T/N classification, resection margin, differentiation grade, and vascular invasion were independent predictors of survival. The externally validated C-index was 0.75 (95%CI: 0.69-0.80), implying good discriminatory capacity. The discriminative ability of the present model after internal validation was superior to the ability of the AJCC staging system (Harrell C-index 0.71, [95%CI: 0.69-0.72) vs. 0.59 (95% CI: 0.57-0.60)]. CONCLUSION: The proposed model for the prediction of overall survival in patients with resected GBC demonstrates good discriminatory capacity, reasonable calibration and outperforms the authoritative AJCC staging system. This model can be a useful tool for physicians and patients to obtain information about survival after resection and is available from https:// gallbladderresearch.shinyapps.io/Predict_GBC_survival/.


Subject(s)
Gallbladder Neoplasms , Humans , Prognosis , Neoplasm Staging , Models, Statistical , Australia
4.
Thromb Res ; 209: 106-114, 2022 01.
Article in English | MEDLINE | ID: mdl-34922160

ABSTRACT

INTRODUCTION: Endothelial damage and thrombosis caused by COVID-19 may imperil cardiovascular health. More than a year since the WHO declared COVID-19 pandemic, information on its effects beyond the acute phase is lacking. We investigate endothelial dysfunction, coagulation and inflammation, 3 months post-COVID-19. MATERIALS AND METHODS: A cohort study was conducted including 203 patients with prior COVID-19. Macrovascular dysfunction was assessed by measuring the carotid artery diameter in response to hand immersion in ice-water. A historic cohort of 312 subjects served as controls. Propensity score matching corrected for baseline differences. Plasma concentrations of endothelin-1 were measured in patients post-COVID-19, during the acute phase, and in matched controls. Coagulation enzyme:inhibitor complexes and inflammatory cytokines were studied. RESULTS AND CONCLUSIONS: The prevalence of macrovascular dysfunction did not differ between the COVID-19 (18.6%) and the historic cohort (22.5%, RD -4%, 95%CI: -15-7, p = 0.49). Endothelin-1 levels were significantly higher in acute COVID-19 (1.67 ± 0.64 pg/mL) as compared to controls (1.24 ± 0.37, p < 0.001), and further elevated 3 months post-COVID-19 (2.74 ± 1.81, p < 0.001). Thrombin:antithrombin(AT) was high in 48.3%. Markers of contact activation were increased in 16-30%. FVIIa:AT (35%) and Von Willebrand Factor:antigen (80.8%) were elevated. Inflammatory cytokine levels were high in a majority: interleukin(IL)-18 (73.9%), IL-6 (47.7%), and IL-1ra (48.9%). At 3 months after acute COVID-19 there was no indication of macrovascular dysfunction; there was evidence, however, of sustained endothelial cell involvement, coagulation activity and inflammation. Our data highlight the importance of further studies on SARS-CoV-2 related vascular inflammation and thrombosis, as well as longer follow-up in recovered patients.


Subject(s)
COVID-19 , Endothelin-1 , Cohort Studies , Humans , Inflammation , Pandemics , SARS-CoV-2
5.
BMC Med ; 18(1): 101, 2020 05 01.
Article in English | MEDLINE | ID: mdl-32354362

ABSTRACT

BACKGROUND: For years, the benefits of septoplasty have been questioned. Due to the scarce and inconclusive literature, several National Health Service (NHS) Clinical Commissioning Groups in England decided to add septal surgery to their list of restricted procedures with low clinical value. Recently, evidence was obtained that septoplasty is actually more effective than non-surgical management for nasal obstruction in adults with a deviated septum. However, the relation between costs and effects of septoplasty remains unknown. METHODS: We conducted an economic evaluation alongside an open, multicenter, pragmatic randomized controlled trial in two tertiary and 16 secondary referral hospitals in the Netherlands. Adults with nasal obstruction and a deviated septum were randomized to (1) septoplasty with or without concurrent turbinate surgery or (2) non-surgical management consisting of (a combination of) medical treatment and watchful waiting. Analyses were performed on an intention-to-treat basis. Single imputation nested in the bootstrap percentile method (using 5000 bootstrap replications) was performed to assess the effect of missing data. After 12 and 24 months, we assessed the incremental costs per quality-adjusted life year (QALY) gained from a healthcare and a societal perspective. RESULTS: A total of 203 adults were randomly assigned to septoplasty (N = 102) or non-surgical management (N = 101). After 12 months, the mean cost difference between septoplasty and non-surgical management using a healthcare or societal perspective was €1181 (95%CI €1038 to €1323) or €2192 per patient (95%CI €1714 to €2670), respectively. The mean QALY difference was 0.03 per patient (95%CI - 0.01 to 0.07). Incremental costs per QALY gained from a healthcare or societal perspective were €41,763 or €77,525, respectively. After 24 months, the mean cost difference between the two groups using a healthcare or societal perspective decreased to €936 (95%CI €719 to €1153) or €1671 per patient (95%CI €952 to €2390), respectively. The mean QALY difference increased to 0.05 per patient (95%CI - 0.03 to 0.14). Incremental costs per QALY gained from a healthcare or societal perspective became €17,374 or €31,024, respectively. Analyses of imputed data did not alter our findings. CONCLUSIONS: Depending on the selected perspective, cost-effectiveness threshold, and time horizon, septoplasty has the potential to be cost-effective. Despite considerable uncertainty, septoplasty seems to be cost-effective from a healthcare perspective, after 24 months against a threshold of €20,000 per QALY. From a societal perspective, septoplasty is not yet cost-effective after 24 months, but it comes closer to the cost-effectiveness threshold as time passes by. TRIAL REGISTRATION: Nederlands Trial Register, NTR3868 (https://www.trialregister.nl/trial/3698). Prospectively registered on February 21, 2013.


Subject(s)
Nasal Obstruction , Adolescent , Adult , Aged , Cost-Benefit Analysis , Female , Humans , Male , Middle Aged , Nasal Obstruction/drug therapy , Nasal Obstruction/economics , Nasal Obstruction/pathology , Nasal Obstruction/surgery , Young Adult
6.
Tech Coloproctol ; 23(12): 1113-1126, 2019 Dec.
Article in English | MEDLINE | ID: mdl-31741099

ABSTRACT

BACKGROUND: Near-infrared (NIR) fluorescence imaging has the potential to overcome the current drawbacks of sentinel lymph node mapping (SLNM) in colon cancer. Our aim was to provide an overview of current SLNM performance and of factors influencing successful sentinel lymph node (SLN) identification using NIR fluorescence imaging in colon cancer. METHODS: A systematic review and meta-analysis was conducted to identify currently used methods and results. Additionally, we performed a single-center study using indocyanine green (ICG) as SLNM dye in colon cancer patients scheduled for a laparoscopic colectomy. SLNs were analyzed with conventional hematoxylin-and-eosin staining and additionally with serial sectioning and immunohistochemistry (extended histopathological assessment). A true-positive procedure was defined as a tumor-positive SLN either by conventional hematoxylin-and-eosin staining or by extended histopathological assessment, independently of regional lymph node status. SLN procedures were determined to be true negatives if SLNs and regional lymph nodes revealed no metastases after conventional and advanced histopathology. SLN procedures yielding tumor-negative SLNs in combination with tumor-positive regional lymph nodes were classified as false negatives. Sensitivity, negative predictive value and detection rate were calculated. RESULTS: This systematic review and meta-analysis included 8 studies describing 227 SLN procedures. A pooled sensitivity of 0.63 (95% CI 0.51-0.74), negative predictive value 0.81 (95% CI 0.73-0.86) and detection rate of 0.94 (95% CI 0.85-0.97) were found. Upstaging as a result of extended histopathological assessment was 0.15 (95% CI 0.07-0.25). In our single-center study, we included 30 patients. Five false-negative SLNs were identified, resulting in a sensitivity of 44% and negative predictive value of 80%, with a detection rate of 89.7%. Eight patients had lymph node metastases, in three cases detected after extended pathological assessment, resulting in an upstaging of 13% (3 of 23 patients with negative nodes by conventional hematoxylin and eosin staining). CONCLUSIONS: Several anatomical and technical difficulties make SLNM with NIR fluorescence imaging in colon cancer particularly challenging when compared to other types of cancer. As a consequence, reports of SLNM accuracy vary widely. Future studies should try to standardize the SLNM procedure and focus on early-stage colon tumors, validation of tracer composition, injection mode and improvement of real-time optical guidance.


Subject(s)
Colonic Neoplasms/pathology , Optical Imaging/methods , Sentinel Lymph Node/diagnostic imaging , Coloring Agents , False Negative Reactions , Humans , Indocyanine Green , Lymph Node Excision , Lymphatic Metastasis , Neoplasm Staging , Predictive Value of Tests , Prospective Studies , Sentinel Lymph Node/pathology , Sentinel Lymph Node/surgery
7.
Sci Rep ; 9(1): 14551, 2019 10 10.
Article in English | MEDLINE | ID: mdl-31601938

ABSTRACT

Tenosynovial giant cell tumors (TGCT), are rare colony stimulating factor-1(CSF-1)-driven proliferative disorders affecting joints. Diffuse-type TGCT often causes significant morbidity due to local recurrences necessitating multiple surgeries. Imatinib mesylate (IM) blocks the CSF-1 receptor. This study investigated the long term effects of IM in TGCT. We conducted an international multi-institutional retrospective study to assess the activity of IM: data was collected anonymously from individual patients with locally advanced, recurrent or metastatic TGCT. Sixty-two patients from 12 institutions across Europe, Australia and the United States were identified. Four patients with metastatic TGCT progressed rapidly on IM and were excluded for further analyses. Seventeen of 58 evaluable patients achieved complete response (CR) or partial response (PR). One- and five-year progression-free survival rates were 71% and 48%, respectively. Thirty-eight (66%) patients discontinued IM after a median of 7 (range 1-80) months. Reported adverse events in 45 (78%) patients were among other edema (48%) and fatigue (50%), mostly grade 1-2 (89%). Five patients experienced grade 3-4 toxicities. This study confirms, with additional follow-up, the efficacy of IM in TGCT. In responding cases we confirmed prolonged IM activity on TGCT symptoms even after discontinuation, but with high rates of treatment interruption and additional treatments.


Subject(s)
Antineoplastic Agents/therapeutic use , Giant Cell Tumor of Tendon Sheath/drug therapy , Imatinib Mesylate/therapeutic use , Adult , Australia , Disease Progression , Disease-Free Survival , Europe , Female , Humans , Middle Aged , Neoplasm Metastasis , Receptors, Colony-Stimulating Factor/antagonists & inhibitors , Retrospective Studies , Treatment Outcome , United States
8.
BMC Musculoskelet Disord ; 20(1): 385, 2019 Aug 22.
Article in English | MEDLINE | ID: mdl-31438921

ABSTRACT

BACKGROUND: Total hip arthroplasty (THA) is used increasingly in younger patients. There is little knowledge about the effect of THA characteristics on risk of revision, especially in young patients. Therefore, we studied the influence of both patient-related and surgical factors on the risk of revision using data from the Dutch Arthroplasty Registry (LROI). METHODS: All patients younger than 55 years with a primary THA implanted in the Netherlands between 2007 and 2017 were selected (n = 19,682). The covariates age, sex, primary diagnosis, ASA-classification, surgical approach, fixation method, bearing type, head size and year of surgery were entered into Cox proportional hazards models to calculate hazard ratios for the risk of revision. RESULTS: The overall 5-year survival of primary THA was 95.3% (95% CI, 94.9-95.6). Use of the anterior approach resulted in a lower risk of revision than the use of the posterolateral approach (HR: 0.66, 95% CI: 0.47-0.92). THAs with a head diameter ≥ 38 mm had a higher risk of revision (HR: 1.90, 95% CI: 1.33-2.72) than THAs with 32 mm heads. Use of MoM bearings resulted in an increased risk when compared to C-PE (HR: 1.76, 95% CI: 1.27-2.43). CONCLUSION: The risk of revision in patients younger than 55 years depends on surgical approach, head size and bearing type. The anterior approach resulted in a decreased risk of revision, whereas use of ≥38 mm heads and MoM bearings resulted in an increased risk of revision for any reason.


Subject(s)
Arthroplasty, Replacement, Hip/adverse effects , Femur Head/anatomy & histology , Hip Prosthesis/adverse effects , Prosthesis Failure , Reoperation/statistics & numerical data , Adult , Arthroplasty, Replacement, Hip/instrumentation , Arthroplasty, Replacement, Hip/methods , Ceramics/adverse effects , Cohort Studies , Female , Femur Head/diagnostic imaging , Femur Head/surgery , Humans , Male , Metal-on-Metal Joint Prostheses/adverse effects , Middle Aged , Netherlands/epidemiology , Polyethylene/adverse effects , Prosthesis Design , Registries/statistics & numerical data , Risk Factors
9.
Bone Joint J ; 101-B(3): 272-280, 2019 Mar.
Article in English | MEDLINE | ID: mdl-30813787

ABSTRACT

AIMS: The aim of this study was to evaluate health-related quality of life (HRQoL) and joint function in tenosynovial giant cell tumour (TGCT) patients before and after surgical treatment. PATIENTS AND METHODS: This prospective cohort study run in two Dutch referral centres assessed patient-reported outcome measures (PROMs; 36-Item Short-Form Health Survey (SF-36), visual analogue scale (VAS) for pain, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)) in 359 consecutive patients with localized- and diffuse-type TGCT of large joints. Patients with recurrent disease (n = 121) and a wait-and-see policy (n = 32) were excluded. Collected data were analyzed at specified time intervals preoperatively (baseline) and/or postoperatively up to five years. RESULTS: A total of 206 TGCT patients, 108 localized- and 98 diffuse-type, were analyzed. Median age at diagnosis of localized- and diffuse-type was 41 years (interquartile range (IQR) 29 to 49) and 37 years (IQR 27 to 47), respectively. SF-36 analyses showed statistically significant and clinically relevant deteriorated preoperative and immediate postoperative scores compared with general Dutch population means, depending on subscale and TGCT subtype. After three to six months of follow-up, these scores improved to general population means and continued to be fairly stable over the following years. VAS scores, for both subtypes, showed no statistically significant or clinically relevant differences pre- or postoperatively. In diffuse-type patients, the improvement in median WOMAC score was statistically significant and clinically relevant preoperatively versus six to 24 months postoperatively, and remained up to five years' follow-up. CONCLUSION: Patients with TGCT report a better HRQoL and joint function after surgery. Pain scores, which vary hugely between patients and in patients over time, did not improve. A disease-specific PROM would help to decipher the impact of TGCT on patients' daily life and functioning in more detail. Cite this article: Bone Joint J 2019;101-B:272-280.


Subject(s)
Giant Cell Tumor of Tendon Sheath/surgery , Neoplasm Recurrence, Local/surgery , Patient Reported Outcome Measures , Quality of Life , Activities of Daily Living , Adult , Female , Giant Cell Tumor of Tendon Sheath/rehabilitation , Humans , Male , Middle Aged , Neoplasm Recurrence, Local/rehabilitation , Prospective Studies , Range of Motion, Articular , Recovery of Function
10.
Bone Joint J ; 101-B(1): 96-103, 2019 01.
Article in English | MEDLINE | ID: mdl-30601046

ABSTRACT

AIMS: The aim of this study was to analyze the effect of a lateral rim mesh on the survival of primary total hip arthroplasty (THA) in young patients, aged 50 years or younger. PATIENTS AND METHODS: We compared a study group of 235 patients (257 hips) who received a primary THA with the use of impaction bone grafting (IBG) with an additional lateral rim mesh with a group of 306 patients (343 hips) who received IBG in the absence of a lateral rim mesh during the same period from 1988 to 2015. In the mesh group, there were 74 male and 183 female patients, with a mean age of 35 years (13 to 50). In the no-mesh group, there were 173 male and 170 female patients, with a mean age of 38 years (12.6 to 50). Cox regression analyses were performed to study the effect of a lateral rim mesh on acetabular component survival. Kaplan-Meier analyses with 95% confidence intervals (CIs) were performed to estimate the survival of the acetabular implant. RESULTS: The hazard ratio for the use of lateral rim mesh, adjusted for potential confounders, for acetabular revision for any reason was 0.50 (95% CI 0.13 to 1.93; p = 0.31) and for acetabular revision for aseptic loosening was 0.29 (95% CI 0.020 to 4.04; p = 0.35). The Kaplan-Meier analysis showed a ten-year survival for aseptic loosening of the acetabular of 98% (95% CI 95 to 100, n = 65 at risk) in the mesh group and 94% (89 to 98, n = 76 at risk) in the no-mesh group. The 15-year survival for aseptic acetabular loosening was 90% (81 to 100, n = 35 at risk) in the mesh group and 85% (77 to 94, n = 45 at risk) in the no-mesh group (p = 0.23). CONCLUSION: This study shows that the use of a lateral rim mesh in primary THA in young patients is not associated with a higher risk of revision of the acetabular component. Therefore, we consider a lateral rim mesh combined with IBG to be effective in reconstructing segmental acetabular defects in primary THA.


Subject(s)
Arthroplasty, Replacement, Hip/methods , Surgical Mesh , Adolescent , Adult , Arthritis, Rheumatoid/surgery , Bone Transplantation/methods , Female , Femur Head Necrosis/surgery , Hip Dislocation, Congenital/surgery , Hip Prosthesis , Humans , Male , Middle Aged , Osteoarthritis, Hip/surgery , Prosthesis Failure/etiology , Reoperation/statistics & numerical data , Retrospective Studies , Young Adult
11.
Osteoarthritis Cartilage ; 27(2): 219-229, 2019 02.
Article in English | MEDLINE | ID: mdl-30317001

ABSTRACT

OBJECTIVE: It is unclear if anterior cruciate ligament (ACL) reconstruction can prevent the onset of degenerative changes in the knee. Previous studies were inconclusive on this subject. The aim of this study was to systematically review all studies on the effect of ACL reconstruction on articular cartilage in animals. DESIGN: Pubmed and Embase were searched to identify all original articles concerning the effect of ACL reconstruction on articular cartilage compared with both its positive (ACL transection) and negative (sham and/or non-operated) control in animals. Subsequently a Risk of bias and meta analysis was conducted based on five outcomes (gross macroscopic assessment, medical imaging, histological histochemical grading, histomophometrics and biomechanical characterization) related to articular cartilage. RESULTS: From the 19 included studies, 29 independent comparisons could be identified which underwent ACL reconstruction with an average timing of data collection of 23 weeks (range 1-104 weeks). Due to limited data availability meta-analysis could only be conducted for gross macroscopic damage. ACL reconstruction caused significant gross macroscopic damage compared with intact controls (SMD 2.0 [0.88; 3.13]). These findings were supported by individual studies reporting on histomorphometrics, histology and imaging. No significant gross macroscopic damage was found when ACL reconstruction was compared with ACL transection (SMD -0.64 [-1.85; 0.57]). CONCLUSION: This systematic review with an average follow up of included studies of 23 weeks (range 1-104 weeks) demonstrates that, in animals, ACL reconstruction does not protect articular cartilage from degenerative changes. The consistency of the direction of effect, provides some reassurance that the direction of effect in humans might be the same.


Subject(s)
Anterior Cruciate Ligament Injuries/surgery , Anterior Cruciate Ligament Reconstruction/methods , Cartilage, Articular/pathology , Knee Joint/pathology , Animals , Bias , Disease Models, Animal , Research Report/standards , Translational Research, Biomedical
13.
Osteoarthritis Cartilage ; 26(2): 184-194, 2018 02.
Article in English | MEDLINE | ID: mdl-28903016

ABSTRACT

OBJECTIVES: It is disputed whether arthroscopic meniscectomy is an (cost-) effective treatment for degenerative meniscus tears in day-to-day clinical practice. The objective of this study was to assess the cost-effectiveness of arthroscopic meniscectomy in subjects with knee osteoarthritis, in routine clinical practice, while taking into account the increased risk for future knee replacement surgery. We compared cost-effectiveness of arthroscopic meniscectomy compared to no surgery. DESIGN: We used a state transition (Markov) simulation model to evaluate the cost-effectiveness of arthroscopic meniscectomy compared to no surgery in subjects with knee osteoarthritis (age range 45-79 years). Data used in the preparation of the current study were obtained from the Osteoarthritis Initiative (AOI) database. We applied a 9 years' time horizon (which is equal to the current OAI study follow up period), and evaluated cost-effectiveness from a societal perspective. The main outcome measure was the incremental cost-effectiveness ratio (Euros per quality adjusted life-year (QALY) gained). RESULTS: Arthroscopic meniscectomy was associated with 8.09 (SD ± 0.07) QALYs at a cost of € 21,345 (SD ± 841), whereas the no surgery was associated with 8.05 (SD ± 0.07) QALYs at a cost of € 16,284 (SD ± 855). For arthroscopic meniscectomy, the incremental cost per QALY gained was € 150,754. CONCLUSIONS: In day-to-day clinical practice, arthroscopic meniscectomy in subjects with knee osteoarthritis is associated with € 150,754 per QALY gained, which exceeds the generally accepted willingness to pay (WTP) (range € 20,000-€ 80,000).


Subject(s)
Arthroscopy/economics , Meniscectomy/economics , Osteoarthritis, Knee/surgery , Tibial Meniscus Injuries/surgery , Aged , Cost-Benefit Analysis , Exercise/physiology , Health Care Costs/statistics & numerical data , Humans , Longitudinal Studies , Male , Markov Chains , Middle Aged , Netherlands , Osteoarthritis, Knee/economics , Pain Management/methods , Quality-Adjusted Life Years , Tibial Meniscus Injuries/economics
15.
Bone Joint J ; 99-B(7): 894-903, 2017 Jul.
Article in English | MEDLINE | ID: mdl-28663394

ABSTRACT

AIMS: The morphometry of the distal femur was largely studied to improve bone-implant fit in total knee arthroplasty (TKA), but little is known about the asymmetry of the posterior condyles. This study aimed to investigate the dimensions of the posterior condyles and the influence of externally rotating the femoral component on potential prosthetic overhang or under-coverage. PATIENTS AND METHODS: We analysed the shape of 110 arthritic knees at the time of primary TKA using pre-operative CT scans. The height and width of each condyle were measured at the posterior femoral cut in neutral position, and in 3º and 5º of external rotation, using both central and medial referencing systems. We compared the morphological characteristics with those of 14 TKA models. RESULTS: In the neutral position, the dimensions of the condyles were nearly equal. Externally rotating the femoral cut by 3º and 5º with 'central referencing' induced width asymmetry > 3 mm in 23 (21%) and 33 (30%) knees respectively, while with 'medial referencing' it induced width asymmetry > 3 mm in 43 (39%) and 75 (68%) knees respectively. The asymmetries induced by rotations were not associated with gender, aetiology or varus-valgus alignment. CONCLUSION: External rotation may amplify the asymmetry between the medial and lateral condyles, and exacerbate prosthetic overhang, particularly in the superolateral zone. 'Central referencing' guides result in less potential prosthetic overhang than 'medial referencing' guides. Cite this article: Bone Joint J 2017;99-B:894-903.


Subject(s)
Arthroplasty, Replacement, Knee/methods , Femur/physiopathology , Femur/surgery , Osteoarthritis, Knee/surgery , Femur/diagnostic imaging , Humans , Osteoarthritis, Knee/diagnostic imaging , Rotation , Tomography, X-Ray Computed
16.
J Biomed Mater Res A ; 105(5): 1405-1411, 2017 05.
Article in English | MEDLINE | ID: mdl-28152576

ABSTRACT

Current treatment methods to repair meniscal tears do not bring fully satisfactory results. Tissue adhesives are considered promising alternatives, since they are easy to apply and cause minimal tissue trauma. The first aim of this study was to analyze the adhesive properties of and tissue response to two recently developed biodegradable block copolymeric three-armed- and hyper-branched tissue adhesives. The second aim was to investigate if tissue surface modification with collagenase improves the attachment of the adhesives and increases the healing potential of the tissue. Cylindrical explants were harvested from bovine menisci. The central core of the explants was removed and glued back into the defect, with or without incubation in collagenase solution prior to gluing, using one of the novel glues, Dermabond® or fibrin glue. The repair constructs were cultured in vitro for 1 and 28 days. Adhesion tests and histology were performed to analyze the effects of the glue in combination with the additional treatment. The adhesive strength of the novel glues was 40-50 kPa, which was significantly higher than that of fibrin glue (15 kPa). Cells were present in direct contact with the glues, and the tissue remained vital during the whole culture period. Increased cellularity around the tear in the collagenase treated explants was observed after 1 day. The two newly developed tissue adhesives are attractive materials to be used for repair of meniscal tears. The beneficial influence of collagenase treatment in treating meniscal tears with glues still needs to be confirmed in more clinical relevant studies. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part A: 105A: 1405-1411, 2017.


Subject(s)
Meniscus , Tibial Meniscus Injuries , Tissue Adhesives , Animals , Cattle , Female , Meniscus/metabolism , Meniscus/pathology , Tibial Meniscus Injuries/metabolism , Tibial Meniscus Injuries/therapy , Tissue Adhesives/chemistry , Tissue Adhesives/therapeutic use
17.
Knee Surg Sports Traumatol Arthrosc ; 25(3): 800-807, 2017 Mar.
Article in English | MEDLINE | ID: mdl-28197694

ABSTRACT

PURPOSE: The objective of this study was to investigate the effect of a medial open-wedge osteotomy (OWO) and the release of the superficial medial collateral ligament (MCL) on the tibiofemoral cartilage pressure, the MCL tension and the valgus laxity of the knee. METHODS: Seven fresh-frozen, human cadaveric knees were used. Medial and lateral mean contact pressure (CP), peak contact pressure (peakCP), and contact area (CA) were measured using a pressure-sensitive film (I-Scan; Tekscan, Boston, MA). The MCL tension was measured using a custom-made device. These measurements were continuously recorded for 5 min after an OWO of 10°. After the osteotomy, the valgus laxity was measured with a handheld Newtonmeter. For one knee, the measurements were continued for 24 h. At the end, a complete release of the superficial MCL was performed and the measurements were repeated at 10°. RESULTS: There was relaxation of the MCL after the osteotomy; the tension dropped in 5 min with 10.7% (mean difference 20.5 N (95% CI 16.1-24.9)), and in 24 h, the tension decreased by 24.2% (absolute difference 38.8 N) (one knee). After the osteotomy, the mean CP, peakCP and CA increased in the medial compartment (absolute difference 0.17 MPa (95% CI 0.14-0.20), 0.27 MPa (95% CI 0.24-0.30), 132.9mm2 (95% CI 67.7-198.2), respectively), and decreased in the lateral compartment (absolute difference 0.02 MPa (95% CI 0.03 -0.01), 0.08 MPa (95% CI 0.11 - 0.04), 47.0 mm2 (95% CI -105.8 to 11.8), respectively). Only after a release of the superficial MCL, the mean CP, peak CP and CA significantly decreased in the medial compartment (absolute difference 0.17, 0.27 MPa, 119.8 mm2, respectively), and increased in the lateral compartment (absolute difference 0.02, 0.11 MPa, 52.4 mm2, respectively). After the release of the superficial MCL, a mean increase of 7.9° [mean difference - 0.1° (95% CI -1.9 to 1.6)] of the valgus laxity was found. CONCLUSIONS: A release of the superficial MCL helps achieve the goal of reducing medial cartilage pressure in an OWO. There was considerable relaxation of the MCL after an OWO that resulted in a decrease of the mean CP in the medial and lateral compartments of the knee over time. However, cartilage pressure shifted from the medial to the lateral compartment only after release of the superficial MCL. The release of the superficial MCL caused a significant increase in the valgus laxity, which could influence stability after an OWO. LEVEL OF EVIDENCE: I.


Subject(s)
Knee Joint/surgery , Medial Collateral Ligament, Knee/surgery , Osteotomy/methods , Tibia/surgery , Weight-Bearing/physiology , Aged , Aged, 80 and over , Cadaver , Humans , Middle Aged
18.
Osteoarthritis Cartilage ; 25(1): 23-29, 2017 01.
Article in English | MEDLINE | ID: mdl-27712957

ABSTRACT

OBJECTIVE: The primary objective was to assess whether patients with knee osteoarthritis and whom undergo arthroscopic meniscectomy have an increased risk for future knee replacement surgery. DESIGN: Data used were obtained from the Osteoarthritis Initiative (OAI) study. SETTING: Participants were enrolled, in four clinical centers, between February 2004 and May 2006 and were followed up on an annual basis up to and including 108-months from enrollment. PARTICIPANTS: 4674 participants (58.4% female), aged 45-79, of all ethnic groups, who had, and those who were at high risk for developing, symptomatic knee osteoarthritis were included, of which 3337 (71.4%) were included in the final follow up visit. MAIN OUTCOME MEASURES: Hazard ratio of knee replacement surgery for participants who underwent arthroscopic meniscectomy during follow up compared to propensity score matched participants who did not undergo arthroscopic meniscectomy during follow up. RESULTS: 335 participants underwent arthroscopic meniscectomy during follow up, of which 63 (18.8%) underwent knee replacement surgery in the same knee. Of the 335 propensity score matched participants 38 (11.1%) underwent knee replacement surgery during follow up. Results from the Cox-proportional hazards model demonstrated that the hazard ratio of knee replacement surgery was 3.03 (95% CI (1.67-5.26)) for participants who underwent arthroscopic meniscectomy relative to the propensity score matched participants who did not undergo arthroscopic meniscectomy. CONCLUSIONS: In patients with knee osteoarthritis arthroscopic knee surgery with meniscectomy is associated with a three fold increase in the risk for future knee replacement surgery.


Subject(s)
Arthroplasty, Replacement, Knee/statistics & numerical data , Arthroscopy/adverse effects , Knee Injuries/surgery , Meniscus/injuries , Aged , Arthroscopy/statistics & numerical data , Female , Humans , Knee Injuries/complications , Longitudinal Studies , Male , Meniscectomy/adverse effects , Meniscectomy/statistics & numerical data , Meniscus/surgery , Middle Aged , Osteoarthritis, Knee/surgery , Risk Factors
19.
Bone Joint J ; 98-B(8): 1086-92, 2016 Aug.
Article in English | MEDLINE | ID: mdl-27482022

ABSTRACT

AIMS: Revision total elbow arthroplasty (TEA) is often challenging. The aim of this study was to report on the clinical and radiological results of revision arthroplasty of the elbow with the Latitude TEA. PATIENTS AND METHODS: Between 2006 and 2010 we used the Latitude TEA for revision in 18 consecutive elbows (17 patients); mean age 53 years (28 to 80); 14 women. A Kudo TEA was revised in 15 elbows and a Souter-Strathclyde TEA in three. Stability, range of movement (ROM), visual analogue score (VAS) for pain and functional scores, Elbow Functional Assessment Scale (EFAS), the Functional Rating Index of Broberg and Morrey (FRIBM) and the Modified Andrews' Elbow Scoring System (MAESS) were assessed pre-operatively and at each post-operative follow-up visit (six, 12 months and biennially thereafter). Radiographs were analysed for loosening, fractures and dislocation. The mean follow-up was 59 months (26 to 89). RESULTS: The ROM of the elbow did not improve significantly. The mean EFAS and MAESS scores improved significantly six months post-operatively (18.6 points, standard deviation (sd) 7.7; p = 0.03 and 28.8 points, sd 8.6; p = 0.006, respectively) and continued to improve slightly or reached a plateau. The mean pain scores at rest (Z = -3.2, p = 0.001) and during activity (Z = -3.2, p = 0.001), and stability (Z = -3.0, p = 0.003) improved significantly six months post-operatively. Thereafter scores continued to improve slightly or a plateau was reached. There were no signs of loosening. CONCLUSION: Revision surgery using the Latitude TEA results in improvement of functionality, reduced pain and better stability of the elbow. Improvement of ROM of the elbow should not be expected. Cite this article: Bone Joint J 2016;98-B:1086-92.


Subject(s)
Arthroplasty, Replacement, Elbow/methods , Adult , Aged , Aged, 80 and over , Arthroplasty, Replacement, Elbow/instrumentation , Elbow Prosthesis , Female , Follow-Up Studies , Humans , Humeral Fractures/diagnostic imaging , Humeral Fractures/physiopathology , Humeral Fractures/surgery , Joint Dislocations/diagnostic imaging , Joint Dislocations/surgery , Joint Instability/surgery , Male , Middle Aged , Pain, Postoperative/prevention & control , Postoperative Complications/diagnostic imaging , Postoperative Complications/surgery , Prosthesis Failure/adverse effects , Prosthesis-Related Infections/diagnostic imaging , Prosthesis-Related Infections/surgery , Range of Motion, Articular/physiology , Reoperation , Therapeutic Irrigation/methods , Treatment Outcome , Young Adult
20.
Bone Joint J ; 98-B(4): 483-9, 2016 Apr.
Article in English | MEDLINE | ID: mdl-27037430

ABSTRACT

AIM: Nail patella syndrome (NPS) is a skeletal dysplasia with patellofemoral dysfunction as a key symptom. We present the first in-depth radiological evaluation of the knee in a large series of NPS patients and describe the typical malformations. PATIENTS AND METHODS: Conventional radiological examination of 95 skeletally mature patients with NPS was performed. Patellar morphology was classified according to the Wiberg classification as modified by Baumgartl and Ficat criteria, and trochlear shape was classified according to the Dejour classification. RESULTS: Patellar aplasia was present in 4/90 (4%), and patellar hypoplasia in 77/90 (86%) of patients. The prevailing patellar shapes were type III, type IV and Hunter's cap. No patellar shape genotype-phenotype association could be found. The malformations of the distal femur comprised shortening of the lateral femoral condyle in 46 out of 84 patients (55%), with a prominent anterior surface of the lateral femoral condyle in 47 out of 84 patients (56%) and a flat anterior surface of the medial femoral condyle in 78 out of 85 patients (92%). The trochlea was type A1 according to the Dejour classification in 79 out of 85 patients (93%). CONCLUSION: An easily recognisable characteristic quartet of malformations consisting of patellar aplasiaor hypoplasia and the malformations of the distal femur was found in 22 out of 81 patients (27%), with the majority displaying at least three malformations. TAKE HOME MESSAGE: The distinct malformations of the knee in nail patella syndrome are easily recognisable on conventional radiographs and lead to the correct interpretation of the aberrant morphology which is essential in the treatment of these patellofemoral disorders.


Subject(s)
Arthrography/methods , Knee Joint/diagnostic imaging , Nail-Patella Syndrome/diagnostic imaging , Adolescent , Adult , Aged , Aged, 80 and over , Female , Follow-Up Studies , Humans , Male , Middle Aged , Patella/diagnostic imaging , Prospective Studies , Severity of Illness Index , Young Adult
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