2020 Mark Coventry Award: Microorganism-directed oral antibiotics reduce the rate of failure due to further infection after two-stage revision hip or knee arthroplasty for chronic infection: a multicentre randomized controlled trial at a minimum of two years

2020 ◽  
Vol 102-B (6_Supple_A) ◽  
pp. 3-9 ◽  
Author(s):  
JaeWon Yang ◽  
Javad Parvizi ◽  
Erik N. Hansen ◽  
Chris N. Culvern ◽  
John C. Segreti ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Knee Arthroplasty ◽  
Controlled Trial ◽  
Joint Infection ◽  
Oral Antibiotics ◽  
Two Stage ◽  
Randomized Controlled ◽  
Rate Of Failure ◽  
To Receive

Aims The aim of this study was to determine if a three-month course of microorganism-directed oral antibiotics reduces the rate of failure due to further infection following two-stage revision for chronic prosthetic joint infection (PJI) of the hip and knee. Methods A total of 185 patients undergoing a two-stage revision in seven different centres were prospectively enrolled. Of these patients, 93 were randomized to receive microorganism-directed oral antibiotics for three months following reimplantation; 88 were randomized to receive no antibiotics, and four were withdrawn before randomization. Of the 181 randomized patients, 28 were lost to follow-up, six died before two years follow-up, and five with culture negative infections were excluded. The remaining 142 patients were followed for a mean of 3.3 years (2.0 to 7.6) with failure due to a further infection as the primary endpoint. Patients who were treated with antibiotics were also assessed for their adherence to the medication regime and for side effects to antibiotics. Results Nine of 72 patients (12.5%) who received antibiotics failed due to further infection compared with 20 of 70 patients (28.6%) who did not receive antibiotics (p = 0.012). Five patients (6.9%) in the treatment group experienced adverse effects related to the administered antibiotics severe enough to warrant discontinuation. Conclusion This multicentre randomized controlled trial showed that a three-month course of microorganism-directed, oral antibiotics significantly reduced the rate of failure due to further infection following a two-stage revision of total hip or knee arthroplasty for chronic PJI. Cite this article: Bone Joint J 2020;102-B(6 Supple A):3–9.

Radiofrequency ablation for markedly incompetent perforators versus compression therapy in the management of post-phelebtic venous ulcers: A randomized controlled trial

Vascular ◽  
2021 ◽  
pp. 170853812110100
Author(s):  
Mohamed Shukri Abdelgawad ◽  
Amr M El-Shafei ◽  
Hesham A Sharaf El-Din ◽  
Ehab M Saad ◽  
Tamer A Khafagy ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Radiofrequency Ablation ◽  
Controlled Trial ◽  
Compression Therapy ◽  
Randomized Controlled ◽  
Venous Ulcers ◽  
Group A ◽  
Group B ◽  
To Receive

Background Venus ulcers developed mainly due to reflux of incompetent venous valves in perforating veins. Patients and methods In this randomized controlled trial, 119 patients recruited over two years, with post-phelebtic venous leg ulcers, were randomly assigned into one of two groups: either to receive radiofrequency ablation of markedly incompetent perforators (Group A, n = 62 patients) or to receive conventional compression therapy (Group B, n = 57 patients). Follow-up duration required for ulcer healing continued for 24 months post randomization. Results Statistically significant shorter time to healing (ulcer complete healing or satisfactory clinical improvement) between both groups (56 patients, 90.3% of cases in Group A versus 44 patients 77.2% of cases in Group B) over the follow-up period of 24 months was attained ( p  = 0.001). Also, significantly different ulcer recurrence was recorded between both groups, 8 patients (12.9%) in Group A versus 19 patients (33.3%) in Group B ( p = 0.004). Conclusion In absence of deep venous obstruction, the monopolar radiofrequency ablation for incompetent perforators is a feasible and effective method that surpasses the traditional compression protocol for incompetent perforator-induced venous ulcers in terms of time required for healing even in the presence of unresolved deep venous valvular reflux.

Manganese and Lipoflavonoid Plus® to Treat Tinnitus: A Randomized Controlled Trial

2016 ◽  
Vol 27 (08) ◽  
pp. 661-668 ◽  
Author(s):  
Eveling Rojas-Roncancio ◽  
Richard Tyler ◽  
Hyung-Jin Jun ◽  
Tang-Chuan Wang ◽  
Haihong Ji ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Data Collection And Analysis ◽  
Loudness Match ◽  
Minimal Masking Level ◽  
Lost To Follow Up ◽  
To Receive

Background: Several tinnitus sufferers suggest that manganese has been helpful with their tinnitus. Purpose: We tested this in a controlled experiment where participants were committed to taking manganese and Lipoflavonoid Plus® to treat their tinnitus. Research Design: Randomized controlled trial. Study Sample: 40 participants were randomized to receive both manganese and Lipoflavonoid Plus® for 6 months, or Lipoflavonoid Plus® only (as the control). Data Collection and Analysis: Pre- and postmeasures were obtained with the Tinnitus Handicap Questionnaire, Tinnitus Primary Functions Questionnaire, and tinnitus loudness and annoyance ratings. An audiologist performed the audiogram, the tinnitus loudness match, and minimal masking level. Results: Twelve participants were dropped out of the study because of the side effects or were lost to follow-up. In the manganese group, 1 participant (out of 12) showed a decrease in the questionnaires, and another showed a decrease in the loudness and annoyance ratings. No participants from the control group (total 16) showed a decrease in the questionnaires ratings. Two participants in the control group reported a loudness decrement and one reported an annoyance decrement. Conclusions: We were not able to conclude that either manganese or Lipoflavonoid Plus® is an effective treatment for tinnitus.

Leucocyte-Rich Platelet-Rich Plasma Treatment of Gluteus Medius and Minimus Tendinopathy: A Double-Blind Randomized Controlled Trial With 2-Year Follow-up

2019 ◽  
Vol 47 (5) ◽  
pp. 1130-1137 ◽  
Author(s):  
Jane Fitzpatrick ◽  
Max K. Bulsara ◽  
John O’Donnell ◽  
Ming Hao Zheng
Keyword(s):  
Randomized Controlled Trial ◽  
Ultrasound Guidance ◽  
Platelet Rich Plasma ◽  
Corticosteroid Injection ◽  
Controlled Trial ◽  
Harris Hip Score ◽  
Randomized Controlled ◽  
Gluteal Tendinopathy ◽  
To Receive

Background: A previously published trial showed that patients with chronic gluteal tendinopathy achieved greater clinical improvement at 12 weeks when treated with a single platelet-rich plasma (PRP) injection than those treated with a single corticosteroid injection (CSI). Purpose: This follow-up study was conducted to determine whether there would be a sustained long-term difference in the modified Harris Hip Score (mHHS) at 2 years for a leucocyte-rich PRP (LR-PRP) injection in the treatment of chronic gluteal tendinopathy. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: This trial included 80 patients randomized 1:1 to receive LR-PRP or CSI intratendinously under ultrasound guidance. Patients had a mean age of 60 years, a 9:1 ratio of women to men, a mean body mass index of 27, and a mean length of symptoms >15 months. No patients had full-thickness tears of the gluteal tendons. An open-labeled extension allowed patients to receive crossover treatment after 3 months. The main outcome measure was the mHHS. Results: The mean mHHS improved significantly at 12 weeks in the PRP group (74.05; SD, 13.92) as compared with the CSI group (67.13; SD, 16.04) ( P = .048). At 24 weeks, the LR-PRP group (77.60; SD, 11.88) improved further than the CSI group (65.72; SD, 15.28; P = .0003). Twenty-seven patients were deemed to have failed the CSI treatment at 16 to 24 weeks, with an exit score of 59.22 (SD, 11.54), and then had treatment with LR-PRP. The crossover group improved with the LR-PRP: from 59.22 (SD, 11.22) at baseline to 75.55 (SD, 16.05) at 12 weeks, 77.69 (SD, 15.30) at 24 weeks, and 77.53 (SD, 14.54) at 104 weeks. The LR-PRP group retained 38 of 39 patients to 52 weeks and continued to improve. Their baseline scores of 53.77 (SD, 12.08) improved to 82.59 (SD, 9.71) at 104 weeks ( P < .0001). Conclusion: Among patients with chronic gluteal tendinopathy and a length of symptoms >15 months, a single intratendinous LR-PRP injection performed under ultrasound guidance results in greater improvement in pain and function than a single CSI. The improvement after LR-PRP injection is sustained at 2 years, whereas the improvement from a CSI is maximal at 6 weeks and not maintained beyond 24 weeks. Registration: ACTRN12613000677707 (Australian New Zealand Clinical Trials identifier).

scholarly journals Anterior Cruciate Ligament Reconstruction Using a Bone–Patellar Tendon–Bone Graft With and Without a Ligament Augmentation Device: A 25-Year Follow-up of a Prospective Randomized Controlled Trial

2018 ◽  
Vol 6 (11) ◽  
pp. 232596711880877 ◽  
Author(s):  
Marlene Mauseth Elveos ◽  
Jon Olav Drogset ◽  
Lars Engebretsen ◽  
Raymond Brønn ◽  
Trond Olav Lundemo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Knee Arthroplasty ◽  
Controlled Trial ◽  
Cruciate Ligament ◽  
Randomized Controlled ◽  
Bptb Graft ◽  
Ligament Augmentation ◽  
Anterior Cruciate ◽  
Bone Patellar Tendon

Background: Various grafts and ligament augmentation devices (LADs) have been used in the search for optimal reconstruction of the anterior cruciate ligament (ACL). Purpose: To compare 25-year follow-up results after ACL reconstruction using a bone–patellar tendon–bone (BPTB) graft with or without the Kennedy LAD. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: One hundred patients undergoing ACL reconstruction between 1991 and 1993 were randomized into 2 groups: reconstruction using a BPTB graft alone (BPTB group, 51 patients) or a BPTB graft with the Kennedy LAD (LAD group, 49 patients). The 25-year follow-up evaluation included a clinical knee examination, patient-reported outcome measures, and an assessment of radiological osteoarthritis (OA) according to the Ahlbäck classification. Additional outcomes were reruptures and knee arthroplasty. Results: Ninety-three patients (93%) were available for the follow-up evaluation: 48 patients in the BPTB group and 45 in the LAD group. Through telephone calls, 26 patients were excluded from further investigation because of reruptures and arthroplasty in the knee of interest; 67 patients were further investigated. A total of 43 of 44 (98%) and 42 of 44 (95%) patients had negative or 1+ Lachman and pivot-shift test results, respectively. The mean Lysholm score was 85 for the BPTB group and 83 for the LAD group. All mean Knee injury and Osteoarthritis Outcome Score (KOOS) subscale values were ≥73. There were no statistically significant differences between groups in any of these outcomes or regarding the Tegner score, radiological classification of OA, or number of ACL reruptures. Signs of radiological OA were detected in all patients, and severe radiological OA (Ahlbäck grade III, IV, or V) was detected in 32% of patients in the BPTB group and 21% of patients in the LAD group ( P = .37). There were 12 patients in the BPTB group and 7 in the LAD group who had documented reruptures ( P = .40). One patient in the BPTB group and 6 in the LAD group underwent knee arthroplasty ( P = .054). Conclusion: In the present study, there were no statistically significant differences between groups in any of the outcomes. After 25 years, 19% of patients had reruptures, 27% had severe radiological OA, and 7% underwent knee arthroplasty.

scholarly journals Efficacy Of Mobile Phone Use On Adherence To Nevirapine Prophylaxis And Retention In Care Among The HIV-Exposed Infants In Prevention Of Mother To Child Transmission Of HIV: A Randomized Controlled Trial

2020 ◽  
Author(s):  
Lilian Maureen Nyatichi Kebaya ◽  
Dalton Wamalwa ◽  
Nyambura Kariuki ◽  
Bashir Admani ◽  
Philip Ayieko ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Retention In Care ◽  
Control Group ◽  
Hiv Exposed Infants ◽  
Randomized Controlled ◽  
Phone Calls ◽  
Hiv Exposed ◽  
To Receive

Abstract Background: HIV is a major contributor to infant mortality. A significant gap remains between the uptake of infant and maternal antiretroviral regimens and only a minority of HIV-exposed infants receives prophylaxis and safe infant feeding. Losses to follow-up of HIV-exposed infants are associated with shortcomings of facility-based PMTCT models with weak community support of linkages. Use of mobile phones offers an opportunity to improving care and promoting retention for the mother-baby pairs and achievement of an HIV-free generation.Objectives: To compare self-reported adherence to infant Nevirapine (NVP) prophylaxis and retention in care over 10 weeks in HIV exposed infants randomized to 2-weekly mobile phone calls (intervention) versus no phone calls (control).Design: Open label Randomized controlled trial Methods: One hundred and fifty HIV infected women drawn from 3 health facilities in Western Kenya and their infants were randomly assigned to receive either phone-based reminders on PMTCT messages or standard health care messages (no calls) within 24 hours of delivery. Women in the intervention arm continued to receive fortnightly phone calls. At 6- and 10-weeks following randomization we collected data on infant adherence to Nevirapine, mode of infant feeding, early HIV testing and retention in care in both study arms. All analyses were intention to treat.Results: At 6 weeks follow-up, 90.7% (n = 68) of participants receiving phone calls reported adherence to infant NVP prophylaxis, compared with 72% (n = 54) of participants in the control group (p = 0.005). Participants in the intervention arm were also significantly more likely to remain in care than participants in the control group [78.7% (n = 59) vs. 58.7% (n = 44), p = 0.009 at 6 weeks and 69.3% (n = 52) vs. 37.3% (n = 28), p < 0.001 at 10 weeks].Conclusions: These results suggest that phone calls are potentially an important tool to improve adherence to infant NVP prophylaxis and retention in care for HIV-exposed infants.Trial registration: PACTR202007654729602. Registered 6 June 2018 - Retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3449

scholarly journals Barbed Sutures in Total Knee Arthroplasty: Are They Really Useful? A Randomized Controlled Trial

2019 ◽  
Vol 33 (09) ◽  
pp. 927-930 ◽  
Author(s):  
Carlo Gamba ◽  
Pedro Hinarejos ◽  
Paula Serrano-Chinchilla ◽  
Joan Leal-Blanquet ◽  
Raul Torres-Claramunt ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Knee Arthroplasty ◽  
Controlled Trial ◽  
Barbed Sutures ◽  
Randomized Controlled ◽  
Closure Time ◽  
Subcutaneous Layer ◽  
Total Knee

AbstractBidirectional barbed sutures (BBSs) have recently been investigated in total knee arthroplasty (TKA). The contrasting results from the scarce literature suggest that BBSs are safe, save time and money, and give results comparable to traditional sutures. The purpose of the study is to test the real effect of BBSs on closure time in TKA and assess the functional results as well as the complications related to them. It was a randomized controlled trial. Eighty-five patients undergoing primary TKA were assigned to receive traditional closure with Vicryl (V-group) or with BBSs (Q-group). The exclusion criteria were significant coronal deformity, flexion contracture, or the need for stem and/or augmentation. The closure time for the capsule and that for the subcutaneous layer were registered separately. Intraoperative incidences were recorded. The follow-up was up to 1 month, during which the range of motion (ROM), superficial or deep infection, and wound dehiscence were assessed. There was a significant reduction in the capsule layer (27 seconds; p = 0.02) and global time closure (51 seconds; p = 0.01) in the Q-group. No differences were found in the subcutaneous layer (24 seconds; p = 0.055). There were more intraoperative suture breakages in the Q-group, mainly in the subcutaneous layer (p < 0.001). No differences in terms of dehiscence, infection, and ROM were observed at the 1-month follow-up. BBSs allow for slightly faster wound closure than Vicryl during a TKA. However, the differences observed have minimal clinical repercussions. Moreover, no differences in the infection rate (deep or superficial), dehiscence, or ROM were found.

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