scholarly journals A randomized controlled trial comparing tibial migration of the ATTUNE cemented cruciate-retaining knee prosthesis with the PFC-sigma design

2020 ◽  
Vol 102-B (9) ◽  
pp. 1158-1166
Author(s):  
Bart L. Kaptein ◽  
Peter den Hollander ◽  
Bregje Thomassen ◽  
Martha Fiocco ◽  
Rob G. H. H. Nelissen
Keyword(s):  
Tibial Component ◽  
Controlled Trial ◽  
Weight Bearing ◽  
Controlled Clinical Trial ◽  
Fixed Bearing ◽  
Cruciate Retaining ◽  
Cement Interface ◽  
Randomized Controlled ◽  
Press Fit ◽  
Patient Reported

Aims The primary objective of this study was to compare migration of the cemented ATTUNE fixed bearing cruciate retaining tibial component with the cemented Press-Fit Condylar (PFC)-sigma fixed bearing cruciate retaining tibial component. The secondary objectives included comparing clinical and radiological outcomes and Patient Reported Outcome Measures (PROMs). Methods A single blinded randomized, non-inferiority study was conducted including 74 patients. Radiostereometry examinations were made after weight bearing, but before hospital discharge, and at three, six, 12, and 24 months postoperatively. PROMS were collected preoperatively and at three, six, 12, and 24 months postoperatively. Radiographs for measuring radiolucencies were collected at two weeks and two years postoperatively. Results The overall migration (mean maximum total point motion (MPTM)) at two years was comparable: mean 1.13 mm (95% confidence interval (CI), 0.97 to 1.30) for the ATTUNE and 1.16 mm (95% CI, 0.99 to 1.35) for the PFC-sigma. At two years, the mean backward tilting was -0.43° (95% CI, -0.65 to -0.21) for the ATTUNE and 0.08° (95% CI -0.16 to 0.31), for the PFC-sigma. Overall migration between the first and second postoperative year was negligible for both components. The clinical outcomes and PROMs improved compared with preoperative scores and were not different between groups. Radiolucencies at the implant-cement interface were mainly seen below the medial baseplate: 17% in the ATTUNE and 3% in the PFC-sigma at two weeks, and at two years 42% and 9% respectively (p = 0.001). Conclusion In the first two postoperative years the initial version of the ATTUNE tibial component was not inferior with respect to overall migration, although it showed relatively more backwards tilting and radiolucent lines at the implant-cement interface than the PFC-sigma. The version of the ATTUNE tibial component examined in this study has subsequently undergone modification by the manufacturer. Level of Evidence: 1 (randomized controlled clinical trial) Cite this article: Bone Joint J 2020;102-B(9):1158–1166.

scholarly journals Ultracongruent insert design is a safe alternative to posterior cruciate-substituting total knee arthroplasty: 5-year results of a randomized controlled trial

2021 ◽  
Author(s):  
Jörg Lützner ◽  
Franziska Beyer ◽  
Cornelia Lützner ◽  
Roman Riedel ◽  
Eric Tille
Keyword(s):  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Knee Arthroplasty ◽  
Controlled Trial ◽  
Patient Reported Outcome ◽  
Fixed Bearing ◽  
Safe Alternative ◽  
Randomized Controlled ◽  
Patient Reported ◽  
Total Knee

Abstract Purpose If substitution of the posterior cruciate ligament in total knee arthroplasty is necessary, there are two options available: posterior stabilized (PS) design with a post-cam mechanism or anterior-lipped ultracongruent (UC) inserts. UC inserts have the advantage that no femoral box is necessary and a standard femoral component can be used. The aim of this study was to compare the range of motion (ROM) and patient-reported outcome (PRO) after UC and PS fixed-bearing TKA. Better ROM in PS TKA and no difference in PRO between both designs was hypothesized. Methods A randomized controlled trial with 127 patients receiving a fixed-bearing UC or PS design of the same knee system was performed. Nine patients died and there were four revision surgeries. 107 patients completed the 5-year follow-up. Patient-reported outcome was assessed. Patellofemoral problems were evaluated using selected applicable questions of the Oxford Knee Score (getting up from a table, kneeling, climbing stairs). Results Surgical time was 10 min shorter in the UC group (p < 0.001). After 5 years, both groups demonstrated good knee function and health-related quality of life without significant differences between the groups. Both groups demonstrated a high satisfaction score and the majority of patients would undergo this surgery again. Patellofemoral problems were recognized more frequently in the PS group (p = 0.025). Conclusion Both designs demonstrated similar good results after 5 years. Stabilization with an anterior-lipped UC insert can be considered a safe alternative to the well-established PS design if cruciate substitution is necessary. Level of evidence 1.

A Randomized Controlled Trial Comparing Traditional Plaster Cast Rehabilitation With Functional Walking Boot Rehabilitation for Acute Achilles Tendon Ruptures

2020 ◽  
Vol 48 (11) ◽  
pp. 2755-2764 ◽  
Author(s):  
Julian F. Maempel ◽  
Nick D. Clement ◽  
Andrew D. Duckworth ◽  
Oisin J.F. Keenan ◽  
Tim O. White ◽  
...  
Keyword(s):  
Achilles Tendon ◽  
Functional Outcomes ◽  
Controlled Trial ◽  
Achilles Tendon Rupture ◽  
Controlled Clinical Trial ◽  
Delayed Presentation ◽  
Foot And Ankle ◽  
Functional Rehabilitation ◽  
Randomized Controlled ◽  
Patient Reported

Background: There has been a shift toward functional nonoperative rehabilitation in the treatment of Achilles tendon rupture (ATR) despite a shortage of studies directly comparing nonoperative functional rehabilitation with traditional nonoperative immobilization. Purpose: To compare patient-reported outcome measures and functional outcomes for nonoperatively treated ATR with traditional cast immobilization or functional rehabilitation in a walking boot. Study Design: Randomized controlled clinical trial; Level of evidence, 2. Methods: In a single-center nonblinded study, 140 patients were randomized to compare treatment for acute ATR in (1) an immobilizing cast in reducing degrees of equinus over a 10-week period with 8 weeks of nonweightbearing mobilization or (2) a walking boot for 8 weeks with reducing equinus and immediate full weightbearing. Exclusion criteria were delayed presentation >2 weeks after injury, tendon reruptures, and latex allergy. Analysis was undertaken on an intention-to-treat basis. Results: A total of 69 patients (median age, 41 years [interquartile range, 33-50.5 years]) were randomized to walking boot treatment and 71 patients (41 [32-49]) to cast treatment. At 6 months, patients treated in a walking boot reported better Short Musculoskeletal Function Assessment (SMFA) dysfunction index (6.62 [2.21-12.50] vs 10.66 [4.96-13.42]; P = .050), SMFA bother index (7.29 [2.08-14.58] vs 10.42 [5.73-19.27]; P = .04), Achilles Tendon Total Rupture Score (71.5 [53.50-84.25] vs 54.0 [37-76]; P = .01), and Foot and Ankle Questionnaire core score (91 [81.89-97.55] vs 85 [78.25-92.09]; P = .04). At 1 year, there was no difference in SMFA dysfunction index (2.21 [0.74-5.88] vs 2.94 [1.47-6.62]; P = .25), SMFA bother index (2.08 [0-9.38] vs 5.21 [0.52-11.98]; P = .25), Achilles Tendon Total Rupture Score (92 [72.50-96] vs 87.5 [66.0-94.75]; P = .21), or Foot and Ankle Questionnaire core score (97.75 [89.46-99.00] vs 95.50 [90.88-97.50]; P = .18). Rerupture occurred in 5 and 11 patients ( P = .075) and venous thromboembolism in 2 and 3 patients ( P = .67) in the boot and cast groups, respectively. Fifteen patients in the boot group but none in the cast group had skin problems ( P < .001). Patients treated in a boot returned to driving at a median 12 weeks (vs 13 weeks for cast; P = .045), but there was no difference in time to return to work ( P = .48). Conclusion: Functional rehabilitation with early weightbearing is a safe alternative to traditional immobilizing treatment for ATR, giving better early functional outcomes, albeit with a higher incidence of transient minor skin complications. Registration: NCT02598843 (ClinicalTrials.gov identifier).

scholarly journals Targeting human milk fortification to improve very preterm infant growth and brain development: study protocol for Nourish, a single-center randomized, controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mandy B. Belfort ◽  
Lianne J. Woodward ◽  
Sara Cherkerzian ◽  
Hunter Pepin ◽  
Deirdre Ellard ◽  
...  
Keyword(s):  
Human Milk ◽  
Brain Size ◽  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Milk Analysis ◽  
Single Center ◽  
Current Standard ◽  
Very Preterm ◽  
Randomized Controlled

Abstract Background Human milk is recommended for very preterm infants, but its variable macronutrient content may contribute to undernutrition during a critical period in development. We hypothesize that individually targeted human milk fortification is more effective in meeting macronutrient requirements than the current standard of care. Methods We designed a single-center randomized, controlled trial enrolling 130 infants born < 31 completed weeks’ gestation. Participants will receive fortified maternal and/or pasteurized donor milk but no formula. For participants in the intervention group, milk will be individually fortified with protein and fat modulars to achieve target levels based on daily point-of-care milk analysis with mid-infrared spectroscopy, in addition to standard fortification. The study diet will continue through 36 weeks’ postmenstrual age (PMA). Clinical staff and parents will be masked to study group. Primary outcomes include: 1) body length and lean body mass by air displacement plethysmography at 36 weeks’ PMA; 2) quantitative magnetic resonance imaging-based measures of brain size and microstructure at term equivalent age; and 3) Bayley-IV scales at 2 years’ corrected age. Discussion We expect this trial to provide important data regarding the effectiveness of individually targeted human milk fortification in the neonatal intensive care unit (NICU). Trial registration NCT03977259, registered 6 June, 2019.

scholarly journals Intrathecal dexmedetomidine improves epidural labor analgesia effects: a randomized controlled trial

2021 ◽  
Vol 49 (4) ◽  
pp. 030006052199953
Author(s):  
Gehui Li ◽  
Hao Wang ◽  
Xiaofei Qi ◽  
Xiaolei Huang ◽  
Yuantao Li
Keyword(s):  
Local Anesthetic ◽  
Controlled Trial ◽  
Intrathecal Injection ◽  
Onset Time ◽  
Labor Analgesia ◽  
Controlled Clinical Trial ◽  
Time Duration ◽  
Clinical Registry ◽  
Randomized Controlled ◽  
Group D

Objective α2‑agonists and opioids have been used as intrathecal adjuvants to local anesthetics for several years, but the effect of intrathecal dexmedetomidine (Dex) or sufentanil combined with epidural ropivacaine in labor analgesia is not fully understood. Methods A total of 108 parturient women receiving combined spinal-epidural labor analgesia were randomly divided into three groups. Group C received l mL saline (0.9%) intrathecally, Group D received 5 µg Dex intrathecally, and Group S received 5 µg sufentanil intrathecally. All parturient women then received 0.1% epidural ropivacaine and 0.2 µg/mL sufentanil for patient-controlled epidural analgesia with standard settings. The visual analog scale score, onset time, duration of intrathecal injection, local anesthetic requirements, and side effects were recorded. Results The labor analgesia effects in Groups D and S were better than those in Group C. Groups D and S displayed significantly shorter onset times, longer durations of intrathecal injection, and reduced local anesthetic requirements compared with Group C. The incidence of shivering and pruritus in Group D was lower than that in Group S. Conclusion Intrathecal administration of 5 µg Dex could improve epidural labor analgesia effects. This randomized controlled clinical trial was registered with the Chinese Clinical Registry Center (ChiCTR-1800014943, http://www.chictr.org.cn/ ).

Efficacy of Chinese Herbal Medicine Jiangniaosuan Formula for Treatment of Hyperuricemia: Study Protocol For A Double-Blinded Non-Inferiority Randomized Controlled Clinical Trial

2021 ◽  
Author(s):  
Yafang Guo ◽  
Hong Lu ◽  
Jing Gan ◽  
Dongdong Li ◽  
Jiandong Gao ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
Chinese Herbal Medicine ◽  
Serum Uric Acid Level ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Chinese Herbal ◽  
To Receive ◽  
Be The Change

Abstract Background: Jiangniaosuan formula (JNSF) is commonly used in China for treating hyperuricemia, but there is little research-based evidence to support its use. This randomized controlled trial aims to assess the efficacy and safety of JNSF.Methods: A total of 72 patients with hyperuricemia will be selected and randomly assigned in a ratio of 1:2 to receive either Western medicine i.e., febuxostat 40 mg (WG group; n = 24) or Chinese herbal medicine group, i.e., Jiangniaosuan formula + febuxostat 20 mg (WJNSG; n = 48). After 12 weeks, the WJNSG will be randomly divided into two groups of 24 patients each; one group (WJNSG; n = 24)still will receive febuxostat 20 mg + Jiangniaosuan formula and the other group(JNSG; n = 24) will continue to receive Jiangniaosuan formula+Placebo. Participants will be followed up at 4-week intervals. The primary outcome will be the change in serum uric acid level, and the secondary outcome will be the change in Traditional Chinese Medicine (TCM) syndrome scores. Serum creatinine, blood glucose, and insulin levels will also be measured.Discussion: We hypothesize that patients with hyperuricemia will benefit from JNSF. This study will provide evidence-based recommendations for clinicians.Dissemination: The results will be published in a peer-reviewed journal and disseminated by academic conferences.Trial registration : This trial is registered with ClinicalTrials.gov, number ChiCTR2000041083. 22 Registered on 3 May 2021.

Effect of a Novel Thermostatic Device on Meibomian Gland Dysfunction: A Randomized Controlled Trial in Chinese Patients

2021 ◽  
Author(s):  
Siyuan Li ◽  
Ke Yang ◽  
Jingyi Wang ◽  
Shang Li ◽  
Lei Zhu ◽  
...  
Keyword(s):  
Group Treatment ◽  
Controlled Trial ◽  
Anterior Segment ◽  
Meibomian Gland ◽  
Chinese Patients ◽  
Meibomian Gland Dysfunction ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Meibomian Glands ◽  
Thermostatic Device

Abstract BackgroundAs a chronic disease, meibomian gland dysfunction (MGD) which causes excessive evaporation of tears by changing the tear film composition, is considered a leading cause of dry eye. Although a variety of physical therapy equipment, there is currently no economical and effective treatment for MGD. The aim of this study was to evaluate the effectiveness and safety of the MiBoFlo Thermoflo® (Mibo Medical, Dallas, TX, USA), a new thermostatic device, on both objective symptoms and subjective signs in Chinese MGD patients.MethodsThis was a prospective, randomized, controlled clinical trial. 108 eyes of 54 MGD patients in Beijing Tongren Hospital were recruited and randomized 1:1 to MiBoFlo (n = 54 eyes) or LipiFlow® (TearScience, Morrisville, NC, USA) (n = 54 eyes) treatment group. In the MiBoFlo group, treatment for each eye took 10 minutes and proceeded every two weeks for a total of three times. Patients in the LipiFlow group received a single 12-minute treatment. Main Outcome Measures: The primary outcomes include changes in Ocular Surface Disease Index (OSDI) score, Meibomian Glands Yielding Liquid Secretion (MGYLS) score and Meibomian Glands Secretion (MGS) score from baseline to 2 months. The secondary outcomes include Tear Meniscus Height (TMH), Non-invasive Keratograph Break-up Time (NIKBUT), Corneal Fluorescein Staining (CFS) and Meibomian Glands (MG) loss from baseline to 2 months. Safety outcomes include visual acuity (VA), intraocular pressure (IOP), anterior segment and facial skin.ResultsThe OSDI score, MGYLS score and MGS score all improved from baseline to 1 month in both MiBoFlo and LipiFlow group, and these improvements were maintained at 2 months. CFS score, NIKBUT and MG loss had no significant change in both groups. CFS score improvement in MiBoFlo group were significantly more obvious than in LipiFlow group in the follow-up visit (p<0.01).ConclusionAs a portable and comfortable device, MiBoFlo treatment can offer an advancement for the treatment of MGD and a course of treatment results in at least two months of sustained improvement in both symptoms and meibomain gland function.

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