scholarly journals Cheilectomy With or Without Cryopreserved Umbilical Cord for Hallux Rigidus: A Prospective Randomized Controlled Trial

2019 ◽  
Vol 4 (4) ◽  
pp. 2473011419S0020
Author(s):  
Sara Heintzman ◽  
Chad Ferguson ◽  
W. Hodges Davis ◽  
Robert B. Anderson ◽  
Bruce E. Cohen ◽  
...  

Category: Midfoot/Forefoot Introduction/Purpose: Arthritis of the first MTP joint (hallux rigidus) is the most common form of osteoarthritis affecting the foot. Despite advances in interpositional techniques and devices, dorsal cheilectomy remains part of the treatment algorithm after failed conservative treatment of hallux rigidus. Dorsal cheilectomy aims to surgically remove dorsal impingement and improve pain and function as well as range of motion. However, prospective data on outcomes following this procedure is lacking. Cryopreserved umbilical cord (UC) allografts have been shown to mitigate inflammation and decrease scar formation. This has theoretical benefit for recovery and disease progression following dorsal cheilectomy. In the first prospective randomized and blinded cheilectomy trial reported, we aimed to compare outcomes of patients undergoing dorsal cheilectomy alone and dorsal cheilectomy with cryopreserved umbilical cord. Methods: After obtaining institutional board review approval, patients were randomized to cheilectomy alone(CA) or cheilectomy with cryopreserved UC. Surgeries were performed by fellowship trained surgeons. Dorsal cheilectomy was performed utilizing fluoroscopy to remove ˜25% articular surface. UC was applied to cheilectomy site and secured inside capsule with absorbable “stay-stitch.” Patients were followed for 1 year with AOFAS MTP-IP, Foot Function Index (FFI), and VAS-pain (walking, waking, and end of day) outcomes collected preoperatively and at 6 months and 1 year. In addition, radiographic range of motion data was collected (maximal dorsiflexion and plantarflexion). Power analysis determined 27 patients per group was needed to detect a significant difference between AOFAS scores of 95(UC) and 85(control). Data was analyzed utilizing statistical analysis software(SAS v9.4). AOFAS MTP-IP, FFI, and VAS scores were analyzed using Wilcoxon signed-rank test. Range of motion data was analyzed using two-way ANOVA with Tukey adjusted least square means test. Results: 51 patients (26 UC, 25 CA) completed the study. There were 5 bilateral surgeries in UC group and 2 in CA group, totaling 31 and 27 feet respectively. Post-operatively, UC group had significantly improved AOFAS and FFI scores at 1 year compared to CA group. There was no difference between groups for VAS-pain scores (walking, waking, or end of day at any time point), but overall VAS-pain improved in both groups from preoperative values. There was no difference seen in range of motion between groups. However, there was an overall improvement in maximal plantarflexion at 6 months and 1 year and maximal dorsiflexion at 6 months in both groups. Conclusion: We present the results of the first randomized and blinded prospective study of cheilectomy surgery patients. There was improvement in range of motion, pain, AOFAS, and FFI scores in all patients with statistically significant improvement at 1 year in AOFAS and FFI scores in the UC group compared to CA group. When appropriately selected, cheilectomy remains a good option for patients with symptomatic hallux rigidus. Cryopreserved umbilical cord is a potential adjuvant to cheilectomy to modulate inflammation and scarring with early 1 year results showing improvements in functional outcome scores.

2020 ◽  
Vol 5 (2) ◽  
pp. 2473011420S0000
Author(s):  
Sara H. Galli ◽  
Chad M. Ferguson ◽  
W. Hodges Davis ◽  
Robert B. Anderson ◽  
Bruce E. Cohen ◽  
...  

Category: Basic Sciences/Biologics; Other Introduction/Purpose: Arthritis of the first MTP joint (hallux rigidus) is the most common form of osteoarthritis affecting the foot. Even with advances in interpositional techniques and devices, dorsal cheilectomy remains part of the treatment algorithm after failed conservative treatment of hallux rigidus. Cheilectomy aims to alleviate dorsal impingement and improve pain and function as well as range of motion. However, prospective data on outcomes following this procedure is lacking.Cryopreserved amniotic membrane-umbilical cord (AM-UC) allograft has been shown to mitigate inflammation and decrease scar formation. This has theoretical benefit for improving outcomes following cheilectomy. In the first prospective randomized and blinded cheilectomy study reported, we aimed to compare outcomes between patients undergoing cheilectomy alone and cheilectomy with cryopreserved amniotic membrane-umbilical cord allograft. Methods: After obtaining institutional board review approval, patients were randomized to cheilectomy alone (CA) or cheilectomy with cryopreserved amniotic membrane-umbilical cord (AM-UC). Surgeries were performed by fellowship trained surgeons. Cheilectomy was performed utilizing fluoroscopy to remove ˜25% dorsal articular surface. Cryopreserved AM-UC was applied to cheilectomy site and secured inside capsule with absorbable ‘stay-stitch.’Patients were followed with AOFAS MTP- IP, Foot Function Index (FFI), and VAS-pain (walking, waking, and end of day) outcomes collected preoperatively and at 6 months and 1 year postoperatively. In addition, radiographic range of motion data was collected (maximal dorsiflexion and plantarflexion) utilizing stress radiographs. Power analysis determined 27 patients per group was needed to detect a difference between AOFAS scores of 95 (AM-UC) and 85 (CA). Data was analyzed utilizing statistical analysis software (SAS v9.4). AOFAS, FFI, and VAS scores were analyzed using Wilcoxon signed-rank test. Range of motion data was analyzed using two-way ANOVA with Tukey adjusted least square means test. Results: 51 patients (26 AM-UC, 25 CA) completed the study. There were 5 bilateral surgeries in AM-UC group and 2 in CA group, totaling 31 and 27 feet respectively. Postoperatively, the AM-UC group had improved AOFAS and FFI scores at 1 year compared to CA group but there was no difference at 6 months. There was no difference between groups for VAS-pain scores (walking, waking, or end of day) at any time point, but overall VAS-pain improved in both groups from preoperative values. There was no difference seen in range of motion (total arc) between groups. In addition, changes in range of motion (total arc) in both groups from preoperative to 1 year postoperative were small. Conclusion: We present the results of the first randomized and blinded prospective study of cheilectomy surgery patients. There was improvement in pain, AOFAS MTP-IP, and FFI scores in all patients with statistically significant improvement at 1 year in AOFAS and FFI scores in the cryopreserved amniotic membrane-umbilical cord group compared to cheilectomy alone group. This was despite minimal change in range of motion in both groups. When appropriately selected, cheilectomy remains a good option for patients with symptomatic hallux rigidus. Cryopreserved amniotic membrane-umbilical cord is a potential adjuvant to cheilectomy to modulate inflammation and scarring with 1 year results showing improvements in functional outcome scores. [Table: see text]


2021 ◽  
Vol 6 (1) ◽  
pp. 247301142096799
Author(s):  
Sara Heintzman Galli ◽  
Chad M. Ferguson ◽  
W. Hodges Davis ◽  
Robert Anderson ◽  
Bruce E. Cohen ◽  
...  

Background: For hallux rigidus, dorsal cheilectomy remains a treatment option even with advances in interposition techniques and devices. Cheilectomy aims to alleviate dorsal impingement and improve pain and function as well as range of motion. Cryopreserved umbilical cord allograft, with properties to mitigate inflammation and scar formation, has theoretical benefit for improving outcomes following cheilectomy. In this first prospective randomized and blinded cheilectomy study reported, we aimed to compare outcomes between cheilectomy alone and cheilectomy with umbilical cord allograft. Methods: Patients were randomized to cheilectomy alone (CA) or cheilectomy with cryopreserved umbilical cord (ie, amniotic membrane–umbilical cord [AM-UC]). Patients were evaluated with American Orthopaedic Foot & Ankle Society (AOFAS), Foot Function Index (FFI), and visual analog scale (VAS) pain outcomes collected preoperatively and at 6 months and 1 year postoperatively. In addition, radiographic range of motion data were collected using stress radiographs. Fifty-one patients (26 AM-UC, 25 CA) completed the study, with 5 bilateral surgeries in the AM-UC group and 2 in the CA group, totaling 31 and 27 feet, respectively. Results: The AM-UC group had statistically significant improved AOFAS and FFI scores at 1 year compared with the CA group, but there was no difference at 6 months. There was no significant difference between groups for VAS-pain scores at any time point, but overall VAS-pain improved in both groups from preoperative values. There was no significant difference in range of motion (total arc) between groups and changes in range of motion (total arc) in both groups from preoperative to 1 year postoperative were small. Conclusion: We present the results of the first randomized and blinded prospective study of cheilectomy surgery patients. When appropriately selected, cheilectomy remains a good option for patients with symptomatic hallux rigidus. Cryopreserved umbilical cord is a potential adjuvant to cheilectomy, with 1-year results showing improvements in functional outcome scores. Level of Evidence: Level II, prospective comparative study.


2021 ◽  
Author(s):  
Olha Holubovska ◽  
Denisa Bojkova ◽  
Stefano Elli ◽  
Marco Bechtel ◽  
David Boltz ◽  
...  

AbstractPandemic SARS-CoV-2 causes a mild to severe respiratory disease called Coronavirus Disease 2019 (COVID-19). Control of SARS-CoV-2 spread will depend on vaccine-induced or naturally acquired protective herd immunity. Until then, antiviral strategies are needed to manage COVID-19, but approved antiviral treatments, such as remdesivir, can only be delivered intravenously. Enisamium (laboratory code FAV00A, trade name Amizon®) is an orally active inhibitor of influenza A and B viruses in cell culture and clinically approved in countries of the Commonwealth of Independent States. Here we show that enisamium can inhibit SARS-CoV-2 infections in NHBE and Caco-2 cells. In vitro, the previously identified enisamium metabolite VR17-04 directly inhibits the activity of the SARS-CoV-2 RNA polymerase. Docking and molecular dynamics simulations suggest that VR17-04 prevents GTP and UTP incorporation. To confirm enisamium’s antiviral properties, we conducted a double-blind, randomized, placebo-controlled trial in adult, hospitalized COVID-19 patients, which needed medical care either with or without supplementary oxygen. Patients received either enisamium (500 mg per dose) or placebo for 7 days. A pre-planned interim analysis showed in the subgroup of patients needing supplementary oxygen (n = 77) in the enisamium group a mean recovery time of 11.1 days, compared to 13.9 days for the placebo group (log-rank test; p=0.0259). No significant difference was found for all patients (n = 373) or those only needing medical care (n = 296). These results thus suggest that enisamium is an inhibitor of SARS-CoV-2 RNA synthesis and that enisamium treatment shortens the time to recovery for COVID-19 patients needing oxygen.Significance statementSARS-CoV-2 is the causative agent of COVID-19. Although vaccines are now becoming available to prevent SARS-CoV-2 spread, the development of antivirals remains necessary for treating current COVID-19 patients and combating future coronavirus outbreaks. Here, we report that enisamium, which can be administered orally, can prevent SARS-CoV-2 replication and that its metabolite VR17-04 can inhibit the SARS-CoV-2 RNA polymerase in vitro. Moreover, we find that COVID-19 patients requiring supplementary oxygen, recover more quickly than patients treated with a placebo. Enisamium may therefore be an accessible treatment for COVID-19 patients.


2015 ◽  
Vol 19 (2) ◽  
pp. 363-370 ◽  
Author(s):  
Gabriel Nama Medoua ◽  
Patricia M Ntsama ◽  
Anne Christine A Ndzana ◽  
Véronique J Essa’a ◽  
Julie Judith T Tsafack ◽  
...  

AbstractObjectiveTo compare an improved corn–soya blend (CSB+) with a ready-to-use supplementary food (RUSF) to test the hypothesis that satisfactory recovery rate will be achieved with CSB+ or RUSF when these foods provide 50 % of the child’s energy requirement, the 50 % remaining coming from usual diet.DesignA comparative efficacy trial study was conducted with moderately wasted children, using a controlled randomized design, with parallel assignment for RUSF or CSB+. Every child received a daily ration of 167 kJ (40 kcal)/kg body weight during 56 d with a follow-up performed every 14 d. Every caregiver received nutrition counselling at enrolment and at each follow-up visit.SettingHealth districts of Mvog-Beti and Evodoula in the Centre region of Cameroon.SubjectsEight hundred and thirty-three children aged 6–59 months were screened and eighty-one malnourished children (weight-for-height Z-score between −3 and −2) aged 25–59 months were selected.ResultsOf children treated with CSB+ and RUSF, 73 % (95 % CI 59 %, 87 %) and 85 % (95 % CI 73 %, 97 %), respectively, recovered from moderate acute malnutrition, with no significant difference between groups. The mean duration of treatment required to achieve recovery was 44 d in the RUSF group and 51 d in the CSB+ group (log-rank test, P=0·0048).ConclusionsThere was no significant difference in recovery rate between the groups. Both CSB+ and RUSF were relatively successful for the treatment of moderate acute malnutrition in children. Despite the relatively low ration size provided, the recovery rates observed for both groups were comparable to or higher than those reported in previous studies, a probable effect of nutrition education.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6058-6058
Author(s):  
Harsh Dhar ◽  
Anil D'Cruz ◽  
Richa Vaish ◽  
Rohini W Hawaldar ◽  
Sudeep Gupta ◽  
...  

6058 Background: Depth of invasion (DOI) has been incorporated in the new AJCC TNM staging (8th edition) for oral cancers. We hypothesized that the negative effect of increasing DOI on outcomes was a result of an increased propensity to node metastasis and appropriate neck treatment would negate its detrimental effect on outcomes. Methods: Patients with T1/ T2 oral squamous cell carcinoma, clinically node negative, from a previously reported Randomized Controlled Trial (NCT 00193765) formed the cohort for this study. Patients were restaged according to the new staging system . Overall survival(OS) was estimated by the revised T stage for the entire cohort and separately for those who underwent END and those who did not (TND arm) using Kaplan Meier and log rank test . Multivariate analysis was performed using Cox proportional hazard model making adjustment for neck treatment, T stage, site, prognostic factors and the interaction between revised T stage and neck treatment. Results: Of the 596 patients 577 were evaluable, with a median follow up of 77.57 months. Initial pT staging was pT1, 389(67.4%); pT2, 181(31.4%); pT3, 7(1.2%) and was modified to pT1, 195(33.8%); pT2, 280(48.5%); pT3, 102(17.7%) on restaging . 288 patients underwent END and 289 did not (TND arm). For the entire cohort 5-year OS rates were 79.0% [95 %CI, 73.12-84.88] for pT1, 69.4% [95% CI, 63.91-74.89] for pT2 and 53.0% [95% CI, 43.2 -62.8] for pT3 with significant difference between the 3 groups (p < 0.001). In those without upfront neck treatment( TND ), OS difference was maintained between the pT1 and pT2 groups [81.1% (95%CI, 73.26-88.94) vs 65.0% (95%CI, 56.77-73.23)], p = 0.004. This difference was not apparent in the END arm ,pT1 -76.9% (95 %CI, 68.47-85.33) vs pT2 -73.7% (95%CI, 66.25-81.15), p = 0.73. T3 tumours had uniformly poor survival irrespective of neck treatment. On multivariate analysis of the revised pT1/T2 cohort (n = 475), pT stage, neck treatment and grade were independent prognostic factors impacting OS. There was a significant interaction between the T stage and neck treatment (p = 0.03). Conclusions: When DOI < 10 mm, END supplants the prognostic implication of depth with similar outcomes for T1 and T2 tumours (new AJCC staging). The exact role of DOI on outcomes warrants further research. Clinical trial information: NCT00193765.


2015 ◽  
Vol 95 (11) ◽  
pp. 1467-1477 ◽  
Author(s):  
Paul A. van den Dolder ◽  
Paulo H. Ferreira ◽  
Kathryn M. Refshauge

Background Soft tissue massage and exercise are commonly used to treat episodes of shoulder pain. Objective The study objective was to compare the effects of soft tissue massage and exercise with those of exercise alone on pain, disability, and range of motion in people with nonspecific shoulder pain. Design This was a randomized controlled trial. Setting The study was conducted in public hospital physical therapy clinics in Sydney, New South Wales, Australia. Participants The study participants were 80 people with an average age of 62.6 years (SD=12.2) who were referred to physical therapists for treatment of nonspecific shoulder pain. Intervention Participants were randomly assigned to either a group that received soft tissue massage around the shoulder and exercises (n=40) or a group that received exercise only (n=40) for 4 weeks. Measurements The primary outcome was improvement in pain, as measured on a 100-mm visual analog scale, 1 week after the cessation of treatment. Secondary outcomes were disability and active flexion, abduction, and hand-behind-back range of motion. Measurements were obtained at baseline, 1 week after the cessation of treatment, and 12 weeks after the cessation of treatment. Results The between-group difference in pain scores from the baseline to 12 weeks after the cessation of treatment demonstrated a small significant difference in favor of the group receiving exercise only (mean difference=14.7 mm). There were no significant differences between groups in any other variable. Limitations It was not possible to mask therapists or participants to group allocation. Diagnostic tests were not used on participants to determine specific shoulder pathology. Conclusions The addition of soft tissue massage to an exercise program for the shoulder conferred no additional benefit for improving pain, disability, or range of motion in people with nonspecific shoulder pain.


2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Qi Wang ◽  
Hui Lv ◽  
Zhao-Tian Sun ◽  
Jian-Feng Tu ◽  
Yong-Wei Feng ◽  
...  

Objective. To explore the feasibility of evaluating the effectiveness and safety of electroacupuncture versus sham electroacupuncture for patients with knee osteoarthritis (KOA). Method. A pilot randomized controlled trial was conducted at a teaching hospital in Beijing. A total of 30 patients with KOA (Kellgren grade II or III) were randomly allocated to an eight-week treatment of either electroacupuncture or sham electroacupuncture. Patients and outcome assessors were blinded to group allocation. The primary outcome was the proportion of responders achieving at least 1.14 seconds decrease in the Timed Up and Go Test (TUG) at week eight compared with baseline. The secondary outcomes included the knee range of motion, the knee extensor and flexor muscle strength, Lequesne index, 9-step stair-climb test (9-SCT), and TUG. Results. Of 30 patients allocated to two groups, 27 (90%) completed the study. The proportion of responders was 53.3% (8 of 15) for electroacupuncture group and 26.7% (4 of 15) for sham electroacupuncture group by the intention-to-treat analysis (P=0.264). There was no statistically significant difference in TUG between the two groups at eight weeks (P=0.856). The compliance rate measured according to patients who conformed to the protocol and had received treatments ≥20 times was 93.3% (28 of 30). The dropout rate was 20% (3 of 15). Adverse effects were not reported in the study. Conclusion. Our research demonstrated that further evaluation of the effectiveness of electroacupuncture versus sham electroacupuncture was feasible and safe for patients with KOA. Whether or not the electroacupuncture can improve the physical functions of knee joint, expand the knee range of motion, and increase the extensor and flexor muscle strength more significantly than sham electroacupuncture, future studies can be designed with larger sample size, randomization design and less biases. This trial is registered with NCT03366363.


2014 ◽  
Vol 104 (5) ◽  
pp. 468-472 ◽  
Author(s):  
Paul Trégouët

BackgroundInjuries of the first metatarsophalangeal joint have lately been receiving attention from researchers owing to the important functions of this joint. However, most of the studies of turf toe injuries have focused on sports played on artificial turf.MethodsThis study compared the range of motion of the first metatarsophalangeal joint in collegiate basketball players (n = 123) and noncompetitive individuals (n = 123).ResultsA statistically significant difference (P &lt; .001) in range of motion was found between the two groups. The difference between the two sample means was 21.35°.ConclusionsWith hallux rigidus being a potential sequela of repeated turf toe injuries, it seems likely that subacute turf toe injuries occur in basketball players, leading to degenerative changes that result in hallux limitus.


2020 ◽  
Vol 8 (5_suppl5) ◽  
pp. 2325967120S0004
Author(s):  
J Fiolin ◽  
IH Dilogo ◽  
AMT Lubis ◽  
JA Pawitan ◽  
IK Liem ◽  
...  

The umbilical cord-mesenchymal stem cells (UC-MSC) has been shown to improve the viability of degenerated chondrocytes in knee osteoarthritis (KOA) in cellular level. Additional somatotropin injection also shown clinical improvement in patients. The present trial is conducted to assess the efficacy of umbilical cord mesenchymal stem cells (UC-MSC) in comparison to somatotropin and hyaluronic acid (HA) injection to treat and slow the progression of knee osteoarthritis. Methods: This study was conducted from January 2016 to April 2018 in Cipto Mangunkusumo General Hospital. A total of 28 knees from 15 patients with early KOA Kellgren Lawrence I-II were randomized into three groups. Group A was treated with 1x106 units of intra-articular UC-MSCs + 2 ml HA followed with 2 consecutive weeks of HA injection; group B was treated with the same dose of HA with additional 8 IU of Somatotropin; group C was treated as control. The International Knee Documentation Committee (IKDC) score, The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), visual analogue score (VAS), were assessed on the 1st and 3rd month, then every 3rd month until 12 months. Cartilage evaluation using MRI cartigram were performed at pre-implantation, and after the 6th and 12th month after implantation Results: General improvement were observed in all groups after 6 and 12 months. The IKDC score improved significantly among groups after 12 months (69.43 [48.3-89.66], 79.31 [51.72-90.08], and 75.9 [67.82-97.7] in group A, B, and C, respectively, p =0.005). We did not find a significant difference between groups in VAS and WOMAC results. However, we observed a medial T2 improvement in group A (39.55 [32.65-67.85] initially and 45.64 [38.12-70.65] 12 months after implantation). Conclusion: Injection of UC-MSC could improve knee function and cartilage profile in early KOA. However, further multicenter studies with larger samples are required to investigate the efficacy of such treatment for treating knee osteoarthritis.


CJEM ◽  
2014 ◽  
Vol 16 (04) ◽  
pp. 296-303 ◽  
Author(s):  
Christina Hiscox ◽  
Jeremy LaMothe ◽  
Neil White ◽  
Mark Bromley ◽  
Elizabeth Oddone Paolucci ◽  
...  

ABSTRACT Background: Many patients with suspected scaphoid fractures but negative radiographs are immobilized for ≥ 2 weeks and are eventually found to have no fracture. Bone scans are reportedly 99% sensitive for these injuries if done ≥ 72 hours postinjury. Objective: The purpose of this study was to determine if early bone scans would allow for shorter cast immobilization periods in patients with suspected scaphoid fractures. Methods: Twenty-seven patients with clinically suspected scaphoid fractures and negative radiographs were randomized to early diagnosis (bone scan within 3–5 days; n 5 12) or traditional diagnosis (radiographs 10–14 days postinjury; n 5 15). The primary outcome was number of days immobilized in a cast. Results: The mean number of days immobilized was 26 in the traditional group and 29 in the bone scan group. Overall, 6 patients had scaphoid fractures (2 in the traditional diagnosis group and 4 in the bone scan group; p &gt; 0.05), and 8 had other types of fractures. These other types of fractures included four distal radius fractures, two triquetral fractures, one trapezoid fracture, and one hamate fracture. There was no significant difference in the number of other types of fractures between groups. The Kaplan-Meier survival analysis using the log-rank test revealed that there was no statistically significant difference between days immobilized between the radiograph and bone scan groups (p 5 0.38). Conclusions: The current study suggests that the use of bone scans to help diagnose occult scaphoid fractures does not reduce the number of days immobilized and that the differential diagnosis of occult scaphoid fractures should remain broad because other injuries are common.


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