Does the Implementation of the PRO-IMPLANT Foundation Treatment Algorithm Improve the Outcome of Chronic Periprosthetic Knee Infections? Mid-Term Results of a Prospective Study

2021 ◽  
Author(s):  
Yannik Hanusrichter ◽  
Sven Frieler ◽  
Jan Gessmann ◽  
Martin Schulte ◽  
Martin Krejczy ◽  
...  
Keyword(s):  
Treatment Options ◽  
Cohort Analysis ◽  
Treatment Algorithm ◽  
Interval Time ◽  
Joint Infections ◽  
Foundation Treatment ◽  
Primary Endpoints ◽  
Eradication Of Infection ◽  
A Prospective Study

Abstract Background Several treatment options for chronic periprosthetic joint infections have been published in the current literature, with an on-going discussion to determine effective management algorithms. Objectives To compare outcomes of the two-stage exchange procedure in revision TKA prior to and after implementation of the PRO-IMPLANT Foundation treatment algorithm. The primary endpoints were defined as (i) revisions during the interval time, (ii) duration of the interval time and (iii) successful PJI eradication. Material and Methods Between 02/2013 and 09/2016, 122 patients were included in a single-centre cohort analysis. 55 patients were treated according to the previously used algorithm (K1) and 67 according to the PRO-IMPLANT Foundation algorithm (K2). A minimum follow-up period of 3 years was set as the inclusion criterion. Successful eradication of infection was defined in accordance with the consensus criteria by Diaz-Ledezma et al. Results Successful eradication was achieved in 42 (67%) patients in K1 and 47 (85.5%) in K2 (p ≤ 0.005). The mean interval time was 88 days (range 51 – 353) in K1 and 52 days (range 42 – 126) in K2 (p ≤ 0.005). In K1, a mean of 0.8 (range 0 – 6) revisions were necessary during the interval period compared with 0.5 (range 0 – 4) in K2 (p = 0.066). Conclusion Implementation of the PRO-IMPLANT treatment algorithm led to significant improvement in the outcome of periprosthetic joint infections. During mid-term follow-up, infection eradication was highly successful, with decreases in the interval time as well as the number of revisions.

scholarly journals Vertebroplasty and kyphoplasty: complementary tecniques for the treatment of painful osteoporotic vertebral compression fractures

2009 ◽  
Vol 8 (1) ◽  
pp. 57-62 ◽  
Author(s):  
Alessio Lovi ◽  
Marco Teli ◽  
Alessandro Ortolina ◽  
Francesco Costa ◽  
Maurizio Fornari ◽  
...  
Keyword(s):  
Bone Biopsy ◽  
Treatment Algorithm ◽  
Vertebral Compression Fractures ◽  
Intractable Pain ◽  
Osteoporotic Vertebral Compression Fractures ◽  
Compression Fractures ◽  
Complementary Techniques ◽  
Similar Good ◽  
A Prospective Study

OBJECTIVE: in a prospective study, we aimed to evaluate the potential use of kyphoplasty (KP) and vertebroplasty (VP) as complementary techniques in the treatment of painful osteoporotic vertebral compression fractures (VCFs). METHODS: after one month of conservative treatment for VCFs, patients with intractable pain were offered treatment with KP or VP according to a treatment algorithm that considers time from fracture (Ät) and amount of Vertebral Body Collapse (VBC). Bone biopsy was obtained intraoperatively to exclude patients affected by malignancy or osteomalacia. RESULTS: hundred and sixty-four patients were included according to the above criteria. Mean age was 67.6 years. Mean followup was 33 months. Ten patients (6.1%) were lost to follow-up and 154 reached the minimum two years follow-up. 118 (69.5%) underwent VP and 36 (30.5%) underwent KP. Complications affected five patients treated with VP, whose one suffered a transient intercostal neuropathy and four a subsequent VCF (two at adjacent level). Results in terms of VAS and Oswestry scores were not different among treatment groups. CONCLUSION: in conclusion, at an average follow-up of almost 3 years from surgical treatment of osteoporotic VCFs, VP and KP show similar good clinical outcomes and appear to be complementary techniques with specific different indications.

Feasibility of collaborative precision medicine oncology between academic- and community-based hospitals.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18015-e18015
Author(s):  
Lorna Rodriguez-Rodriguez ◽  
Mark Krasna ◽  
Kim M. Hirshfield ◽  
Veronica Rojas ◽  
Gregory Riedlinger ◽  
...  
Keyword(s):  
Precision Medicine ◽  
Community Hospital ◽  
Treatment Options ◽  
Cohort Analysis ◽  
Hospital Setting ◽  
Tumor Board ◽  
Health Staff ◽  
Study Enrollment ◽  
The Impact

e18015 Background: The Rutgers Cancer Institute of New Jersey (CINJ) is conducting an ongoing, prospective, observational clinical trial that is evaluating use of comprehensive genomic profiling (CGP) and molecular tumor board (MTB) review to assist in caring for patients with rare or refractory cancers. As part of this precision medicine approach to cancer care, CINJ has formed a partnership with community hospitals (Meridian Health) to enroll patients in this study, and to actively participate in MTB meetings. The purpose of this cohort analysis is to evaluate the feasibility of using CGP to identify clinically-relevant genomic alterations as an aid to guiding point-of-care management in a community hospital setting. Methods: Meridian Health staff was trained in patient selection, enrollment, and follow-up. CGP was performed by Foundation Medicine, Inc. The patient case’s clinical history, pathology, and CGP results were presented at an MTB meeting. The enrolling physicians (n = 11) were invited to attend the MTB in person or through web-accessible video conferencing. A letter listing MTB consensus recommendations on potential treatment options was sent to the referring physician, and patient follow-up was scheduled at regular intervals. Results: 35 patients were enrolled by Meridian Health. Gyn and GI cancers were the most common types at enrollment (each 26%, 9 out of 35), followed by breast cancer (20%, 7 out of 35). At study enrollment, the mean KPS was 91%, and 23 patients (66%) had stage IV disease. The median duration between study enrollment and MTB presentation was 44 days. 3 patients were excluded because of deteriorated clinical status at the time of the MTB. MTB-based treatment options were implemented in 9 of 32 patients (28%). This result is similar to those reported in published analyses of patients enrolled at CINJ. Conclusions: Collaborations between an academic cancer center and a community hospital is a feasible approach to facilitating access to precision medicine for cancer patients treated in the community. A larger cohort is needed to determine the impact on patient’s outcomes.

Checkmate-040: Nivolumab (NIVO) in patients (pts) with advanced hepatocellular carcinoma (aHCC) and Child-Pugh B (CPB) status.

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 327-327 ◽  
Author(s):  
Masatoshi Kudo ◽  
Ana Matilla ◽  
Armando Santoro ◽  
Ignacio Melero ◽  
Antonio Cubillo Gracian ◽  
...  
Keyword(s):  
Treatment Options ◽  
Objective Response ◽  
Advanced Hepatocellular Carcinoma ◽  
Primary Endpoints ◽  
Group Methods ◽  
The Us ◽  
Duration Of Response ◽  
Report Data ◽  
Unacceptable Toxicity

327 Background: Pts with aHCC and CPB liver status are often excluded from clinical trials of novel therapies due to their poor prognosis (Greten British J Cancer 2005). Historical overall survival (OS) for these pts when treated with sorafenib (SOR) has ranged ≈3–5 mo in retrospective or descriptive studies (Abou-Alfa Gastrointest Cancer Res 2011; Da Fonseca Mol Clin Oncol 2015; Pressiani Ann Oncol 2013; Chiu Cancer 2012); thus, novel treatment options are needed for these pts. The PD-1 inhibitor NIVO is approved in the US, Canada, and elsewhere, most recently Australia, for SOR-treated pts with aHCC based on results from CheckMate-040 (NCT01658878) (El-Khoueiry Lancet 2017). Here we report data from the CPB cohort of CheckMate-040, the first prospective study of immunotherapy in this pt group. Methods: Pts with CPB (B7–B8) aHCC who were SOR-naïve (n = 25) or -experienced (n = 24) received NIVO 240 mg IV for 30 min Q2W until unacceptable toxicity or disease progression. Primary endpoints were objective response rate (ORR) (investigator assessed [INV], RECIST v1.1) and duration of response (DOR). Safety was assessed in all treated pts using NCI CTCAE v4.0. Results: Of 49 analyzed pts, 28 (57.1%) had vascular invasion or extrahepatic spread. During a follow-up range of 6–18 mo, INV ORR was 10.2% with 5 pts responding; disease control rate (DCR) was 55.1%. Median (m) time to response was 2.7 mo and mDOR was 9.9 mo; 2 pts had ongoing responses at data cutoff. The mOS was 7.6 mo (mOS follow-up was 7.4 mo); mOS in SOR-naïve and -treated pts was 9.8 and 7.3 mo, respectively. Treatment-related adverse events (TRAEs) were reported in 25 (51%) pts; 4 (8.2%) pts had select hepatic TRAEs. TRAEs led to discontinuation in 2 pts (4.1%). NIVO safety profile in these pts appeared comparable to cohorts of pts with CPA aHCC. Comparison data for pts with CPA aHCC and extended follow-up for pts with CPB aHCC will be presented. Conclusions: Encouraging DCR and durable responses were observed in pts with CPB aHCC treated with NIVO. AEs were manageable and did not lead to higher discontinuation compared with pts with CPA aHCC. NIVO showed promising efficacy and tolerability compared with historical data, supporting further investigation. Clinical trial information: NCT01658878.

scholarly journals Comparison of efficacy of mirabegron and darifenacin in overactive bladder- a prospective study

2020 ◽  
Vol 8 (1) ◽  
pp. 196
Author(s):  
Gurpreet Singh Bhangu ◽  
Kamal Preet Kaur ◽  
Darpan Bansal ◽  
Ritansh Bansal
Keyword(s):  
Overactive Bladder ◽  
Drug Treatment ◽  
Comparative Study ◽  
Prospective Study ◽  
Treatment Options ◽  
Signs And Symptoms ◽  
Medical Sciences ◽  
Once Daily ◽  
A Prospective Study

Background: Overactive bladder (OAB) is under reported yet distressing symptoms which can be managed effectively by the drugs available. Aim was to study and compare the efficacy of two drugs, mirabegron and darifenacin in controlling the symptoms of overactive bladder.Methods: This prospective study included a total of 120 cases of overactive bladder reported at Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar from January 2018 to December 2019. This comparative study was done by giving Mirabegron to first five patients and next five patients were given darifenacin up to 120 patients. The drug treatment with once daily administration of 25 mg mirabegron and 7.5 mg of darifenacin was given for a total of 12 weeks. The signs and symptoms were noted at the beginning of the therapy and then follow up was done at 4, 8, 10 and 12 weeks.Results: Total 54 out of 60 patients (90%) on miragaberon and 59 of 60 patients (98.33%) on darifenacin were relieved of symptom of increased frequency of micturition. 53 of 60 pateints (88.33%) on miragaberon and 59 of 60 patients (98.33%) on darifenacin were relieved of symptom of decreased average voiding volume. 28 of 60 pateints (46.67 %) on miragaberon showed nocturia as compared to 25 of 60 patients (41.67%) on darifenacin.Conclusions: It has been concluded that both mirabegron as well as darifenacin are highly efficacious newer treatment options for the management of OAB. Our study found Darifenacin to be relatively more efficacious in the treatment of OAB at a lesser dose and statistically significant differences were observed between the two drugs. 

scholarly journals Three-stage revision arthroplasty for the treatment of fungal periprosthetic joint infection: outcome analysis of a novel treatment algorithm

2021 ◽  
Vol 2 (8) ◽  
pp. 671-678
Author(s):  
Hinnerk Baecker ◽  
Sven Frieler ◽  
Jan Geßmann ◽  
Stephan Pauly ◽  
Thomas A. Schildhauer ◽  
...  
Keyword(s):  
Antifungal Therapy ◽  
Joint Infection ◽  
Treatment Algorithm ◽  
Revision Arthroplasty ◽  
Salvage Procedure ◽  
Entire Treatment Period ◽  
Joint Infections ◽  
Novel Treatment ◽  
Systemic Antifungal Therapy

Aims Fungal periprosthetic joint infections (fPJIs) are rare complications, constituting only 1% of all PJIs. Neither a uniform definition for fPJI has been established, nor a standardized treatment regimen. Compared to bacterial PJI, there is little evidence for fPJI in the literature with divergent results. Hence, we implemented a novel treatment algorithm based on three-stage revision arthroplasty, with local and systemic antifungal therapy to optimize treatment for fPJI. Methods From 2015 to 2018, a total of 18 patients with fPJI were included in a prospective, single-centre study (DKRS-ID 00020409). The diagnosis of PJI is based on the European Bone and Joint Infection Society definition of periprosthetic joint infections. The baseline parameters (age, sex, and BMI) and additional data (previous surgeries, pathogen spectrum, and Charlson Comorbidity Index) were recorded. A therapy protocol with three-stage revision, including a scheduled spacer exchange, was implemented. Systemic antifungal medication was administered throughout the entire treatment period and continued for six months after reimplantation. A minimum follow-up of 24 months was defined. Results Eradication of infection was achieved in 16 out of 18 patients (88.8%), with a mean follow-up of 35 months (25 to 54). Mixed bacterial and fungal infections were present in seven cases (39%). The interval period, defined as the period of time from explantation to reimplantation, was 119 days (55 to 202). In five patients, a salvage procedure was performed (three cementless modular knee arthrodesis, and two Girdlestone procedures). Conclusion Therapy for fPJI is complex, with low cure rates according to the literature. No uniform treatment recommendations presently exist for fPJI. Three-stage revision arthroplasty with prolonged systemic antifungal therapy showed promising results. Cite this article: Bone Jt Open 2021;2(8):671–678.

Cetuximab/radiotherapy (CET+RT) versus concomitant chemoradiotherapy (cCHT+RT) with or without induction docetaxel/cisplatin/5-fluorouracil (TPF) in locally advanced head and neck squamous cell carcinoma (LASCCHN): Preliminary results on toxicity of a randomized, 2x2 factorial, phase II-III study (NCT01086826).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 5513-5513 ◽  
Author(s):  
Maria Grazia Ghi ◽  
Adriano Paccagnella ◽  
Daris Ferrari ◽  
Paolo Foa ◽  
Franco Nole ◽  
...  
Keyword(s):  
Phase Ii ◽  
Standard Treatment ◽  
Treatment Options ◽  
Locally Advanced ◽  
Disease Stage ◽  
Advanced Head ◽  
Concomitant Chemoradiotherapy ◽  
Primary Endpoints ◽  
Ecog Ps

5513 Background: The standard treatment options for LASCCHN are cCHT+RT or CET+RT. Strategies to improve the efficacy with the integration of induction chemotherapy are being investigated. Primary endpoints of this study were to compare: 1) the overall survival (OS) of induction vs. no induction arms; 2) the Grade(G)3-4 in-field toxicity of cCHT+RT vs. CET+RT. Methods: Patients (pts) with unresectable LASCCHN, stage III-IV, ECOG PS 0–1 were randomized to a 2x2 factorial design: Arm A1: cCHT+RT (2 cycles of ciplatin/5fluorouracil); Arm A2: CET+RTX; Arm B1: 3 cycles of TPF followed by the same cCHT+RT; Arm B2: 3 cycles of TPF followed by CET+RT. A total of 204 deaths over 420 pts ( including the 101 randomized in the phase II part of the study comparing cCHT+RT with or w/o induction TPF) were required to detect a HR of death of 0.675 (A1+A2 vs. B1+B2; 2-sided a=0.05; b=0.20) and a 10% difference in G3-4 in-field mucosal toxicity (A1+B1 vs. A2+B2). Results: By February 2012, 387 pts over 413 pts were evaluable for toxicity. 82% of pts were male; median age was 60y; PS: 0=77.8% and 1=22.2%. Disease stage was III (31%) or IV (69%). Sites of disease were oral cavity (21.7%), oropharynx (54.8%), hypopharynx (23.5%). At a median follow-up of 21 months, 126 deaths occurred. Data on G3-4 in-field toxicity (primary endpoint) and compliance to cCHT+RT vs CET+RT are shown in the table. Conclusions: No advantage for CET+RT over cCHT+RT was observed regarding G3-4 in-field toxicities and feasibility. Pts are still being followed-up to assess OS. [Table: see text]

Concurrent durvalumab and radiation therapy followed by adjuvant durvalumab in patients with locally advanced urothelial cancer of bladder (DUART): Btcrc-GU15-023.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 513-513 ◽  
Author(s):  
Monika Joshi ◽  
Leonard Tuanquin ◽  
Matthew Kaag ◽  
Deepak Kilari ◽  
Sheldon L. Holder ◽  
...  
Keyword(s):  
Radiation Therapy ◽  
Statistical Power ◽  
Treatment Options ◽  
Locally Advanced ◽  
Drop Out ◽  
Total N ◽  
Primary Endpoints ◽  
Secondary Endpoints ◽  
Grade 3

513 Background: Bladder cancer (BC) patients (pts) who are cisplatin ineligible/unfit for surgery, unresectable have limited treatment options. In this study, we investigate if the combination of radiation therapy (RT) and checkpoint inhibitor, durvalumab (durva) is safe and effective in these pts. Our results from phase (ph) Ib suggested that the combination was safe. Here we present the response rate post durvaRT and updated treatment related adverse events (TRAEs) amongst our evaluable pts in ph II. Methods: This is a single arm ph Ib-II study for T2-4 N0-2 M0 pts. The ph II primary endpoints a) PFS rate at 1 yr b) disease control rate (DCR); secondary endpoints were a) CR post durvaRT b) PFS c) OS. Pts were treated with durva (1500mg) Q4 wks x2 doses along with definitive RT (64.8Gy, 36 fractions over 7 wks) to the bladder and involved nodes followed by adjuvant durva Q4 wks x 1 yr. Response was evaluated with CT scan and cystoscopy+biopsy post durvaRT. We anticipated that durvaRT followed by durva would increase PFS at 1 yr from 50% to 75% when compared to RT; we assumed DCR of about 75%. A total of 26 pts were needed to reach a statistical power of at least 80% at one-sided alpha of 5% and to allow for 10% drop out rate. Results: Total N = 26 patients (male 19; female 7, median age 74yr). At the time of data cut off, 21/26 pts were evaluable for response post durvaRT. Post completion of durvaRT time point, clinical CR was seen in 15/21 pts (71.4%); PR 1/21 pts (4.7%); SD 4/21 (19%); PD 1/21 (4.7%). DCR was seen in 20/21 pts (95%) post durvaRT. Median follow up from D1 to last follow up was 6.1 mos. Grade ≥ 3 TRAE amongst 26 pts: anemia (1/26), lipase/amylase (1/26), immune nephritis (1/26), dyspnea (gr 4, copd/immune), fatigue (1/26), lymphopenia (6/26). Other TRAEs: Fatigue was the most common TRAE (16/26); UTI (5/26); cystitis (3/26). No fatal TRAEs were observed. Conclusions: DurvaRT demonstrated promising efficacy with clinical CR of 71.4% and DCR of 95% in unresectable, cisplatin ineligible locally advanced BC. It was generally well tolerated. Ph II study has completed accrual and longer-term results will further our understanding of this regimen’s efficacy in locally advanced BC. Clinical trial information: NCT02891161.

A standardized interdisciplinary algorithm for the treatment of prosthetic joint infections

2019 ◽  
Vol 101-B (2) ◽  
pp. 132-139 ◽  
Author(s):  
D. Karczewski ◽  
T. Winkler ◽  
N. Renz ◽  
A. Trampuz ◽  
E. Lieb ◽  
...  
Keyword(s):  
Treatment Algorithm ◽  
Interdisciplinary Team ◽  
Control Group ◽  
Time Interval ◽  
Study Group ◽  
Historical Cohort ◽  
Joint Infections ◽  
Prosthetic Joint ◽  
Prosthetic Joint Infections

AimsIn 2013, we introduced a specialized, centralized, and interdisciplinary team in our institution that applied a standardized diagnostic and treatment algorithm for the management of prosthetic joint infections (PJIs). The hypothesis for this study was that the outcome of treatment would be improved using this approach.Patients and MethodsIn a retrospective analysis with a standard postoperative follow-up, 95 patients with a PJI of the hip and knee who were treated with a two-stage exchange between 2013 and 2017 formed the study group. A historical cohort of 86 patients treated between 2009 and 2011 not according to the standardized protocol served as a control group. The success of treatment was defined according to the Delphi criteria in a two-year follow-up.ResultsPatients in the study group had a significantly higher Charlson Comorbidity Index (3.9 vs 3.1; p = 0.009) and rate of previous revisions for infection (52.6% vs 36%; p = 0.025), and tended to be older (69.0 vs 66.2 years; p = 0.075) with a broader polymicrobial spectrum (47.3% vs 33.7%; p = 0.062). The rate of recurrent infection (3.1% vs 10.4%; p = 0.048) and the mean time interval between the two stages of the procedure (66.6 vs 80.7 days; p < 0.001) were reduced significantly in the study group compared with the control group.ConclusionWe were able to show that the outcome following the treatment of PJIs of the hip and knee is better when managed in a separate department with an interdisciplinary team using a standard algorithm.

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