scholarly journals Early Outcomes of a Synthetic Cartilage Implant for Treatment of Hallux Rigidus: A Series of 87 Patients

2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0015
Author(s):  
Michael A. Campbell
Keyword(s):  
Real World ◽  
Case Series ◽  
Hallux Rigidus ◽  
Time Interval ◽  
Pivotal Trial ◽  
Human Cartilage ◽  
First Metatarsophalangeal Joint ◽  
Real World Setting ◽  
Positive Results

Category: Midfoot/Forefoot; Bunion Introduction/Purpose: Arthritis of the first metatarsophalangeal joint (MTPJ), or hallux rigidus, is the most common arthritic condition of the foot, affecting 1 in 40 people over 50 years of age. One surgical option is the implantation of a synthetic polyvinyl alcohol hydrogel implant that has water content, tensile strength, and biomechanical properties similar to those of healthy human cartilage. This implant is supported by positive outcomes in a Level 1 clinical trial out to over 5 years follow-up. The objective of this case series was to determine if the positive results seen in the pivotal trial could be recreated in a ‘real world’ setting. Methods: All patients implanted with a synthetic cartilage implant by a single surgeon between September 2016 and December 2018 were retrospectively reviewed. Consecutive adult patients diagnosed with hallux rigidus that failed nonoperative treatment were included in the analysis. Patient demographics, complications, Foot and Ankle Ability Measures (FAAM), and a 10-point visual analog score (VAS) were collected from the chart review. Results: A total of 87 patients were available for review during the time interval of interest with a mean length of follow-up of 38.7 weeks (range, 2-125). The average patient age was 56.6 years (range, 21-80). Two (2.3%) patients were converted to fusion. The first at 71 weeks and the second at 73 weeks following the initial surgery. Six (6.9%) patients experienced some complications: 3 cases of synovitis treated with corticosteroid injection; 1 case of sesamoiditis; 1 case of neuritis; and 1 insufficiency fracture at the plantar aspect of the MTPJ with implant subsidence. Patients had mean FAAM ADL and VAS scores of 81.2 (range 21-100) and 0.6 (range, 0-3), respectively, at final follow-up. Conclusion: This retrospective review is one of the first presentations of outcomes for a synthetic cartilage implant in a ‘real world’ setting. Patients experienced excellent pain relief, good functional outcomes, and a satisfactory survival rate. This case series confirms the positive results seen in the original pivotal trial for this device.

Evaluation of Metatarsal Head Resurfacing Hemiarthroplasty in the Surgical Treatment of Hallux Rigidus: A Retrospective Study and Mid- to Long-Term Follow-up

2017 ◽  
Vol 11 (1) ◽  
pp. 22-31 ◽  
Author(s):  
Musa Uğur Mermerkaya ◽  
Erkan Alkan ◽  
Mehmet Ayvaz
Keyword(s):  
Surgical Treatment ◽  
Case Series ◽  
Metatarsophalangeal Joint ◽  
Metatarsal Head ◽  
Treatment Method ◽  
Hallux Rigidus ◽  
Retrospective Case ◽  
First Metatarsophalangeal Joint

Background. The aim of this study was to evaluate the mid- to long-term outcomes of metatarsal head resurfacing hemiarthroplasty in the surgical treatment of advanced-stage hallux rigidus. Methods. We performed a retrospective review of 57 consecutive patients (25 [43.9%] males, 32 [56.1%] females; mean age, 61.0 ± 6.4 years) who underwent first metatarsal head resurfacing hemiarthroplasty (HemiCAP) for hallux rigidus between August 2007 and September 2010. Sixty-five implantations were performed in 57 patients; 8 patients underwent bilateral procedures. All patients were clinically rated prior to surgery and at the final follow-up visit using the American Orthopaedic Foot and Ankle Society (AOFAS) hallux metatarsophalangeal-interphalangeal scale and first metatarsophalangeal joint range of motion (MTPJ ROM). Results. The median follow-up duration was 81 (range = 8-98) months. The median preoperative AOFAS score was 34 (range = 22-59) points, which had increased to 83 (range = 26-97) points at the final follow-up visit (P < .001). The median preoperative first MTPJ ROM was 25° (range = 15° to 40°), which had increased to 75° (range = 30° to 85°) at the final follow-up visit (P < .001). Conclusions. First MTPJ hemiarthroplasty is an effective treatment method that recovers toe function and first MTPJ ROM, and provides good mid- to long-term functional outcomes. Levels of Evidence: Level IV: Retrospective case series

Long-term Follow-up of Cheilectomy for Treatment of Hallux Rigidus

2019 ◽  
Vol 40 (10) ◽  
pp. 1114-1121 ◽  
Author(s):  
Eliezer Sidon ◽  
Ryan Rogero ◽  
Timothy Bell ◽  
Elizabeth McDonald ◽  
Rachel J. Shakked ◽  
...  
Keyword(s):  
Case Series ◽  
Hallux Rigidus ◽  
Long Term Results ◽  
Retrospective Case ◽  
Level Of Evidence ◽  
First Metatarsophalangeal Joint ◽  
Significant Difference ◽  
Long Term Follow Up

Background:Hallux rigidus is the most common arthritic condition in the foot. First metatarsophalangeal joint cheilectomy produces satisfactory results in retrospective studies with reported good to excellent results in up to 97% and pain relief and function in 92%. The results of cheilectomy for higher grades of hallux rigidus are less favorable. The purpose of this study was to evaluate the long-term functional results and survivorship of cheilectomy for treatment of hallux rigidus.Methods:This was a retrospective, questionnaire-based study investigating the long-term results of cheilectomy for treatment of hallux rigidus. The preoperative arthritic grade was graded retrospectively according to the Hattrup and Johnson (H&J) grading system. A questionnaire was administered via email or telephone that included questions regarding pain recurrence following surgery, current functional status, and satisfaction with the operation. Kaplan-Meier survival analysis was performed to estimate survival time between arthritic grades. We reviewed 165 patients (169 feet) with an average follow-up of 6.6 (5.0-10.9) years.Results:The overall survival rate (painless at the time of last follow-up) was 70.4% (119 feet), with no significant difference between the 3 H&J arthritic grades. Most of the recurrences (28 feet, 75%) were at the first 2 years following the surgery. Nine feet (5.3%) had a second procedure at a mean postoperative time of 3.6 (range, 1.6-7.4) years. Of the 169 feet, 117 (69.3%) reported being satisfied or very satisfied and 127 (75.1%) indicated they would repeat the operation under the same circumstances.Conclusion:Our study supports the use of cheilectomy for treatment of hallux rigidus (grade 1-3 Coughlin and Shurnas) as a reliable procedure with favorable results. At long-term follow-up, patients who underwent cheilectomy had a low revision rate and a moderately low rate of pain recurrence.Level of Evidence:Level IV, retrospective case-series.

Karzinome des Magens und ösophagogastralen Übergangs: Leitlinienempfehlung für die palliative Erstlinientherapie bestätigt

2021 ◽  
pp. 1-2
Author(s):  
Michael Stahl
Keyword(s):  
Real World ◽  
Median Overall Survival ◽  
Progression Free Survival ◽  
Her2 Positive ◽  
Free Survival ◽  
Real World Setting ◽  
Epidermal Growth ◽  
Positive Results ◽  
High Diversity

<b>Background:</b> The observational study HerMES collected primary data on effectiveness and safety of trastuzumab in patients with human epidermal growth receptor 2 (HER2)-positive cancer of the stomach or gastroesophageal junction (GEJ) in routine clinical practice, exploring the treatment with trastuzumab, chemotherapy backbones used, and the HER2 testing in a real-world setting in Germany. <b>Subjects, materials, and methods:</b> This noninterventional study observed patients with histologically confirmed, HER2-positive metastatic adenocarcinoma of the stomach or GEJ, who were treated with trastuzumab according to the physicians’ judgement and clinical practice. The observation phase per patient took as long as the duration of the trastuzumab therapy, but for a maximum of 12 months. A subsequent extended follow-up phase lasted until the patient’s death or the end of the study, that is, 2 years from start of the follow-up phase of the last patient. All data were analyzed descriptively. <b>Results:</b> Between February 2010 and July 2016, 364 patients were observed at 171 sites throughout Germany. The median overall survival was 14.1 months and the median progression-free survival was 7.9 months. The overall response rate was 43%. Safety was in line with previous reports. This study observed a high diversity of chemotherapy regimens that were combined with trastuzumab. Post hoc subgroup analyses showed differences in outcomes according to the chemotherapy regimen used. <b>Conclusion:</b> Trastuzumab treatment in everyday practice as observed in HerMES confirmed the positive results of the pivotal study ToGA in an observational, real-world setting. <b>Implications for practice:</b> Real-world data of trastuzumab treatment of patients with gastroesophageal or gastric metastatic adenocarcinoma confirmed the positive results of the pivotal clinical trial. The observed median overall survival was 14.1 months and the median progression-free survival was 7.9 months. Although recommendations concerning administration of trastuzumab were well implemented, a high diversity of chemotherapy regimens were combined with trastuzumab. Regimens other than the in-label regimens, especially oxaliplatin-based doublets or 5-fluorouracil, leucovorin, oxaliplatin, taxane triplets, were used in 29% of patients. Observation of a second, marginal HER2-positivity population confirmed the benefit of trastuzumab predominantly for well-confirmed human epidermal growth receptor 2 (HER2)-positive tumors and the requirement of reliable HER2 testing.

scholarly journals Metatarsophalangeal arthroscopy of the hallux

2019 ◽  
Vol 13 (2) ◽  
pp. 119-123
Author(s):  
Maria Augusta Back Nascimento ◽  
Anna Carolina Coelho Nogueira ◽  
Carlos Daniel Cândido de Castro Filho ◽  
André Vitor Kerber Cavalcante Lemos ◽  
Mário Sérgio Paulillo de Cillo ◽  
...  
Keyword(s):  
Case Series ◽  
Metatarsophalangeal Joint ◽  
Hallux Rigidus ◽  
Modified Technique ◽  
Level Of Evidence ◽  
First Metatarsophalangeal Joint ◽  
Nylon Mesh ◽  
Before And After ◽  
Traction Device

Objective: This study sought to describe a modified arthroscopic technique in which a traction device with a horizontal vector and nylon mesh are used to allow continuous and uniform distraction without requiring an assistant surgeon to perform manual traction. Methods: Nine patients (seven females and two males; mean age 31.8 [30-52] years) with an indication for treatment of this joint who had been diagnosed with different pathologies, including synovitis, hallux vagus, and hallux rigidus, were selected and underwent arthroscopy of the first metatarsophalangeal joint using this modified technique. Results: Patient evaluations determined using the American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale were recorded before and after surgery. The mean scores before and after the procedure were 43.66 (32-55) and 95.22 (90-8), respectively. No scars or joint complications were observed at a six-month follow-up, and all subjects experienced rapid recovery and quickly returned to daily functions. Conclusion: Similarly to conventional arthroscopy of the metatarsophalangeal joint, the modified technique produced satisfactory surgical outcomes; moreover, this technique reduced surgical time and improved the surgeon’s autonomy by obviating the need for an assistant surgeon to perform traction. Level of Evidence IV; Therapeutic Studies; Case Series.

Outcomes After Interpositional Arthroplasty of the First Metatarsophalangeal Joint

2017 ◽  
Vol 38 (5) ◽  
pp. 514-518 ◽  
Author(s):  
Michael C. Aynardi ◽  
Lara Atwater ◽  
Eric J. Dein ◽  
Talal Zahoor ◽  
Lew C. Schon ◽  
...  
Keyword(s):  
Case Series ◽  
Metatarsophalangeal Joint ◽  
Hallux Rigidus ◽  
Level Of Evidence ◽  
First Metatarsophalangeal Joint ◽  
Interpositional Arthroplasty ◽  
Significant Difference ◽  
Patient Reported ◽  
Functional Scores

Background: For patients with hallux rigidus seeking a motion-sparing procedure, interposition arthroplasty is an alternative to fusion. The purpose of this study was to report patient outcomes after interpositional arthroplasty for hallux rigidus. Methods: All patients undergoing interpositional arthroplasty at our institution from 2001 to 2014 were identified and a retrospective chart review was performed. Follow-up was conducted through a telephone survey to obtain survivorship, satisfaction, and functional scores. Survivorship of the interpositional arthroplasty procedure was defined as no subsequent surgery on the hallux after the index procedure. Patients were excluded for incomplete records. Complications were recorded. From 2001 to 2014, 183 patients were identified. Of these, 14 were excluded for incomplete data, leaving 169 patients. Of these, 133 had an average follow-up of 62.2 months (range, 24.3 months to 151.2 months). Results: The overall failure rate was 3.8% (5/133). Patient-reported outcome was rated as excellent in 65.4% (87/133) or good in 24.1% (32/133) of patients and fair or poor in 10.5% (14/133) of patients. Of 133 patients, 101 (76%) were able to return to fashionable or regular footwear. The infection rate was 1.5% (2/133). Patient-reported cock-up deformity of the first metatarsophalangeal joint (MTPJ) occurred in 4.5% (6/133) of patients. In addition, 17.3% (23/133) of patients reported metatarsalgia of the second or third MTPJ at the time of final follow-up, and there was no significant difference between interposition types ( P = .441). Conclusion: Interpositional arthroplasty for hallux rigidus was found to have excellent or good results in most patients at a mean follow-up of 62.2 months. Level of Evidence: Level IV, retrospective case series.

Midterm Outcomes of Polyvinyl Alcohol Hydrogel Hemiarthroplasty of the First Metatarsophalangeal Joint in Advanced Hallux Rigidus

2016 ◽  
Vol 38 (3) ◽  
pp. 243-247 ◽  
Author(s):  
Timothy R. Daniels ◽  
Alastair S. E. Younger ◽  
Murray J. Penner ◽  
Kevin J. Wing ◽  
Sara Lyn Miniaci-Coxhead ◽  
...  
Keyword(s):  
Polyvinyl Alcohol ◽  
Functional Outcomes ◽  
Short Form ◽  
Case Series ◽  
Hallux Rigidus ◽  
Radiographic Evaluation ◽  
First Metatarsophalangeal Joint ◽  
Sf 36 ◽  
Pva Hydrogel

Background: Hallux rigidus is the most common arthritic condition of the foot. A randomized clinical trial of first metatarsophalangeal (MTP) joint hemiarthroplasty with a polyvinyl alcohol (PVA) hydrogel implant (Cartiva) demonstrated pain relief and functional outcomes equivalent to first MTP arthrodesis at 2 years postoperation, with no cases of implant fragmentation, wear, or bone loss. We prospectively determined 5-year outcomes of first MTP hemiarthroplasty with the PVA hydrogel implant. Methods: Patients who underwent first PVA hydrogel MTP hemiarthroplasty in the previously reported trial were evaluated at 5 years postoperatively. Patients underwent physical examination and radiographic evaluation and completed a pain VAS, the Short-Form-36 (SF-36), and the Foot and Ankle Ability Measure (FAAM) sports subscale and activities of daily living (ADL) subscale. At the time of this study, 29 patients had reached 5 years’ follow-up. Two were lost to follow-up, leaving 27 patients with mean age 56.1 (range, 40.1-71.9) years. Mean follow-up was 5.4 (range, 4.9-6.4) years. Results: Postoperative active MTP natural joint dorsiflexion and peak MTP dorsiflexion were mean 18.2 (range, 10.0-30.0) and 29.7 (range, 10.0-45.0) degrees, respectively. Pain VAS, SF-36 PCS, FAAM ADL, and FAAM Sports scores demonstrated clinically and statistically significant improvements. Radiographically, no patient demonstrated changes in implant position, implant loosening or subsidence, or implant wear. One implant was removed because of persistent pain and converted to fusion 2 years postoperation. Conclusion: Five years following first MTP hemiarthroplasty with a PVA hydrogel implant, functional outcomes improved significantly, pain was reduced significantly, and the implant demonstrated excellent survivorship. Level of Evidence: Level IV, prospective case series.

scholarly journals Long-Term Follow-Up of Denosumab Discontinuers with Multiple Vertebral Fractures in the Real-World: A Case Series

2021 ◽  
Author(s):  
Liana Tripto-Shkolnik ◽  
Yair Liel ◽  
Naama Yekutiel ◽  
Inbal Goldshtein
Keyword(s):  
Real World ◽  
Vertebral Fractures ◽  
Clinical Laboratory ◽  
Case Series ◽  
High Risk Group ◽  
Imaging Data ◽  
Long Term Follow Up ◽  
Multiple Vertebral Fractures

AbstractDenosumab discontinuation is associated with rapid reversal of bone turnover suppression and with a considerable increase in fracture risk, including a risk for multiple vertebral fractures (MVF). Long-term follow-up of patients who sustained MVF after denosumab discontinuation has not been reported. This case-series was aimed to provide a long-term follow-up on the management and outcome of denosumab discontinuers who initially presented with multiple vertebral fractures. Denosumab discontinuers were identified from a computerized database of a large healthcare provider. Baseline and follow-up clinical, laboratory, and imaging data were obtained from the computerized database and electronic medical records. The post-denosumab discontinuers MVF patients consisted of 12 women aged 71±12. Osteoporotic fractures were prevalent before denosumab discontinuation in 6 of the patients. The majority received bisphosphonates before denosumab. MVF occurred 134±76 days after denosumab discontinuation. The patients were followed for a median of 36.5 (IQR 28.2, 42.5) months after MVF. Two patients passed-away. Two patients suffered recurrent vertebral fractures. Following MVF, patients were treated inconsistently with denosumab, teriparatide, oral, and intravenous bisphosphonates, in various sequences. Two patients underwent vertebroplasty/kyphoplasty. This long-term follow-up of real-world patients with MVF following denosumab discontinuation reveals that management is inconsistent, and recurrent fractures are not uncommon. It calls for clear management guidelines for patients with MVF after denosumab discontinuation and for special attention to this high-risk group.

scholarly journals Real-World Clinical Outcomes Associated with Canagliflozin in Patients with Type 2 Diabetes Mellitus in Spain: The Real-Wecan Study

2020 ◽  
Vol 9 (7) ◽  
pp. 2275
Author(s):  
Juan J. Gorgojo-Martínez ◽  
Manuel A. Gargallo-Fernández ◽  
Alba Galdón Sanz-Pastor ◽  
Teresa Antón-Bravo ◽  
Miguel Brito-Sanfiel ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Real World ◽  
Primary Outcome ◽  
Baseline Hba1c ◽  
Real World Setting ◽  
Antihyperglycemic Therapy ◽  
The Mean ◽  
Hba1c Levels

The aims of this multicentric retrospective study were to assess in a real-world setting the effectiveness and safety of canagliflozin 100 mg/d (CANA100) as an add-on to the background antihyperglycemic therapy, and to evaluate the intensification of prior sodium–glucose co-transporter type 2 inhibitor (SGLT-2i) therapy by switching to canagliflozin 300 mg/d (CANA300) in patients with T2DM. One cohort of SGLT2i-naïve patients with T2DM who were initiated on CANA100 and a second cohort of patients with prior background SGLT-2i therapy who switched to CANA300 were included in the study. The primary outcome of the study was the mean change in HbA1c over the follow-up time. In total, 583 patients were included—279 in the cohort of CANA100 (HbA1c 8.05%, weight 94.9 kg) and 304 in the cohort of CANA300 (HbA1c 7.51%, weight 92.0 kg). Median follow-up periods in both cohorts were 9.1 and 15.4 months respectively. CANA100 was associated to significant reductions in HbA1c (−0.90%) and weight (−4.1 kg) at the end of the follow-up. In those patients with baseline HbA1c > 8% (mean 9.25%), CANA100 lowered HbA1c levels by 1.51%. In the second cohort, patients switching to CANA300 experienced a significant decrease in HbA1c (−0.35%) and weight (−2.1 kg). In those patients with baseline HbA1c > 8% (mean 8.94%), CANA300 lowered HbA1c levels by 1.12%. There were significant improvements in blood pressure in both cohorts. No unexpected adverse events were reported. In summary, CANA100 (as an add-on therapy) and CANA300 (switching from prior SGLT-2i therapy) significantly improved several cardiometabolic parameters in patients with T2DM.

One-year Follow-Up Results with Hydrogel Implant in Therapy of Hallux Rigidus: Case Series with 44 Patients

2021 ◽  
Author(s):  
Christoph Zanzinger ◽  
Norbert Harrasser ◽  
Oliver Gottschalk ◽  
Patrick Dolp ◽  
Florian Hinterwimmer ◽  
...  
Keyword(s):  
Learning Algorithm ◽  
Case Series ◽  
Metatarsophalangeal Joint ◽  
Hallux Rigidus ◽  
Therapy Failure ◽  
Retrospective Case ◽  
Aofas Score ◽  
Medium Level ◽  
One Year

Abstract Background The Cartiva implant (CI) is being increasingly used in the surgical therapy of hallux rigidus. Despite a growing number of studies, numerous questions regarding patient selection remain unanswered. Patients and Methods As part of a retrospective case series with prospective follow-up (average follow-up period: 12 months), a total of 44 patients (male/female = 16/28; mean age at the time of surgery: 55.4 years) with 44 CI were analysed (VAS, EFAS-, AOFAS-score). Using a correlation analysis and a machine learning algorithm, risk factors for therapy failure were investigated. Results The overall survival rate of the CI was 93% at 12 months. The VAS, EFAS and AOFAS scores showed a significant improvement in comparison to the preoperative condition. The mobility of the metatarsophalangeal joint showed no increase. Patients with a medium osteoarthritis grade and a medium level of clinical restraint showed the greatest improvement in relation to their preoperative condition. Conclusion The CI can be seen as an effective therapy for hallux rigidus. Nonetheless, realistic patient expectations must be communicated.

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