Prospective Multicenter Randomized Controlled Trial Comparing Early Protected Movement and Splinting for Fifth Metacarpal Neck Fracture

2021 ◽  
pp. 229255032110119
Author(s):  
Helene Retrouvey ◽  
Josephine Jakubowski ◽  
Mona Al-Taha ◽  
Anna Steve ◽  
Haley Augustine ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Grip Strength ◽  
Reference Values ◽  
Functional Outcomes ◽  
Controlled Trial ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Patient Reported ◽  
Elastic Bandage

Background: Fifth metacarpal neck fractures account for 20% of all hand fractures, yet there remains debate with respect to management, particularly when conservative treatment is initiated. The objective of this study is to compare functional and patient-reported outcomes (PROs) in patients treated with early protected movement or splint immobilization. Methods: This national multicenter prospective randomized controlled trial compared 2 groups; elastic bandage with early protected movement versus immobilization with splinting. Demographic characteristics were collected at baseline. Functional outcomes (grip strength testing) and PROs (Brief Michigan Hand Questionnaire [bMHQ]) were collected at 4, 8, and 12 weeks post-intervention. Grip strength values of the injured hand were normalized to both the non-injured hand (at baseline), and the Canadian reference values. Results: Thirty-seven participants from 5 Canadian centers were randomized into the splint (n = 21) or elastic bandage group (n = 16). There were no significant differences in the bMHQ score between the splint (52.1 ± 27.2) or the elastic bandage (46.6 ± 20.4) groups ( P = .51). There were no differences in baseline grip strength between the splint (15.3 ± 8.9 kg) and elastic bandage (19.9 ± 7.5 kg) groups. At 8 weeks, the elastic bandage group had a significantly higher grip strength than the splint group (93% vs 64%, respectively: P < .05), when standardized as a percentage of the Canadian reference values. Conclusion: Patients with Boxer’s fractures treated with early protected movement had better functional outcomes by 8 weeks post-treatment as compared to the Canadian reference values of those treated with immobilization and splinting. Providers should manage Boxer’s fractures with early protected movement.

scholarly journals A Randomized Controlled Single-Blind Study Demonstrating Superiority of Amniotic Suspension Allograft Injection Over Hyaluronic Acid and Saline Control for Modification of Knee Osteoarthritis Symptoms

2019 ◽  
Vol 32 (11) ◽  
pp. 1143-1154 ◽  
Author(s):  
Jack Farr ◽  
Andreas H. Gomoll ◽  
Adam B. Yanke ◽  
Eric J. Strauss ◽  
Katie C. Mowry ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hyaluronic Acid ◽  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Saline Control ◽  
Knee Oa ◽  
Randomized Controlled ◽  
Symptomatic Knee ◽  
Multicenter Randomized Controlled Trial ◽  
Patient Reported

AbstractPlacental-derived tissues are a known source of anti-inflammatory and immune modulating factors. Published pilot data on amniotic suspension allograft (ASA) for the treatment of osteoarthritis (OA) demonstrated safety and trends for improved pain and function. A multicenter randomized controlled trial was designed to evaluate the efficacy of symptom modulation with ASA compared with saline and hyaluronic acid (HA) in subjects with knee OA. A total of 200 subjects were randomized 1:1:1 to ASA, HA, or saline, with subjects blinded to their allocation. Changes from baseline of patient-reported outcomes (PROs)—EQ-5D-5L, Knee Osteoarthritis Outcome Score (KOOS), visual analog scale (VAS), Tegner, and Single Assessment Numerical Evaluation (SANE)—were compared between groups. Patients reporting unacceptable pain at 3 months were considered treatment failures and withdrawn from the study. Statistical analysis was completed by comparing changes in PROs from baseline to 3 and 6 months for all groups. Comparison of demographics between treatment groups showed no significant differences between groups. Patients reporting unacceptable pain at 3 months in each group were ASA (13.2%), HA (68.8%), and saline (75%). Patients receiving ASA demonstrated significantly greater improvements from baseline for overall pain (VAS), KOOS pain, and KOOS-activities of daily living scores compared with those in the HA group (3 months) and both groups (6 months). ASA patients had significantly greater improvements in KOOS symptom scores compared with HA and saline at 3 and 6 months, respectively. OMERACT-OARSI responder rates for ASA, HA, and saline groups were 69.1, 39.1, and 42.6%, respectively (p = 0.0007). Subjects receiving ASA treatment showed greater improvements in PROs and fewer patients reported unacceptable pain compared with HA and saline. The evidence presented in this Level I Randomized Controlled Trial suggests that ASA injection is an effective treatment for the nonoperative management of symptomatic knee OA.

scholarly journals Cardiovascular Risk Comparison between Expanded Hemodialysis Using Theranova and Online Hemodiafiltration (CARTOON): A Multicenter Randomized Controlled Trial

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Yeonhee Lee ◽  
Myoung-jin Jang ◽  
Junseok Jeon ◽  
Jung Eun Lee ◽  
Wooseong Huh ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Controlled Trial ◽  
Rank Test ◽  
Cardiovascular Parameters ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Patient Reported ◽  
Echocardiographic Parameters

AbstractExpanded hemodialysis (HDx) with medium cutoff (MCO) membranes, which remove middle-to-large molecules well, may be a good option to replace online hemodiafiltration (online-HDF). To provide more evidence, this randomized controlled trial compared several cardiovascular parameters between patients undergoing HDx and online-HDF. Eighty patients undergoing thrice-weekly hemodialysis were randomly assigned to receive either HDx with a Theranova membrane (n = 43) or online-HDF (n = 37). The primary endpoints were changes in brachial-ankle pulse wave velocity (baPWV), echocardiographic parameters, and coronary artery calcium (CAC) scores over 1 year, and the secondary endpoints included blood cardiovascular biomarkers, mortality, and patient-reported outcomes. A linear mixed model and log-rank test were used to estimate the group differences. 65 patients had completed the trial. The changes in baPWV and echocardiographic parameters did not differ between the two groups. The CAC scores remained stable in the online-HDF group, whereas an increasing trend was shown in the HDx group (P = 0.012). Other endpoints, including cardiovascular and all-cause mortalities, were similar between the two groups. The changes in cardiovascular parameters did not differ between HDx with an MCO membrane and online-HDF. However, attention may be needed in patients with high CAC scores or scores with an increasing tendency when online-HDF is replaced with HDx with an MCO membrane.

scholarly journals Psychoeducational groups for adults with ADHD and their significant others (PEGASUS): A pragmatic multicenter and randomized controlled trial

2017 ◽  
Vol 44 ◽  
pp. 141-152 ◽  
Author(s):  
T. Hirvikoski ◽  
T. Lindström ◽  
J. Carlsson ◽  
E. Waaler ◽  
J. Jokinen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Life Satisfaction ◽  
Controlled Trial ◽  
Significant Others ◽  
Effective Treatment Option ◽  
Post Intervention ◽  
Treatment As Usual ◽  
Randomized Controlled ◽  
Psychiatric Outpatient ◽  
Multicenter Randomized Controlled Trial

AbstractObjective:To examine the feasibility, efficacy, and effectiveness of PEGASUS, a group-based structured psychoeducation for adults with ADHD and their significant others.Method:A pragmatic parallel group add-on design multicenter randomized controlled trial was conducted, comparing an 8-session treatment with PEGASUS (allocated n = 97; 48 with ADHD and 49 with significant others) to treatment as usual (TAU, allocated n = 82; 39 with ADHD and 43 significant others). Participants (individuals with ADHD and significant others) were recruited from five psychiatric outpatient departments and block randomized to PEGASUS or TAU. Knowledge about ADHD was measured using the ADHD 20 scale pre- and post-intervention and served as primary outcome.Results:Knowledge about ADHD (d = 0.97 [95% CI: 0.61–1.31]) increased following PEGASUS participation compared to TAU. Improvements were also observed in secondary outcomes e.g. global life satisfaction (d = 0.25 [95% CI: from –0.09 to 0.59]). Overall treatment satisfaction was good. Over 90% of the participants completed the program. Post-intervention data was obtained from n = 89 in PEGASUS group and n = 70 in TAU group and analyses were conducted per protocol. No important adverse effects or side effects were observed.Conclusions:Group-based structured psychoeducation PEGASUS for adults with ADHD and their significant others is a feasible, efficacious, and effective treatment option to increase ADHD knowledge and general life satisfaction in psychiatric outpatient care.

scholarly journals Therapeutic Efficacy of Autologous Platelet Concentrate Injection on Macular Holes with High Myopia, Large Macular Holes, or Recurrent Macular Holes: A Multicenter Randomized Controlled Trial

2021 ◽  
Vol 10 (12) ◽  
pp. 2727
Author(s):  
Mirinae Kim ◽  
Jae-Yon Won ◽  
Seung-Yong Choi ◽  
Minhee Kim ◽  
Ho Ra ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Functional Outcomes ◽  
High Myopia ◽  
Controlled Trial ◽  
Platelet Concentrate ◽  
Randomized Controlled ◽  
Macular Holes ◽  
Multicenter Randomized Controlled Trial ◽  
Autologous Platelet Concentrate ◽  
Autologous Platelet

We aimed to evaluate the anatomical and functional outcomes of pars-plana vitrectomy (PPV) with or without autologous platelet concentrate (APC) injection in patients with recurrent macular holes (MHs), large MHs, or MHs with high myopia. This multicenter, prospective, interventional randomized controlled trial was conducted from March 2017 to April 2020. Participants were randomly allocated to a PPV group or a PPV+APC group. All participants underwent standard 25-gauge PPV, and eyes in the PPV+APC group underwent PPV with intravitreal APC injection before air-gas exchange. A total of 117 patients were enrolled (PPV group: n = 59, PPV+APC group: n = 58). Hole closure was achieved in 47 participants (79.7%) in the PPV group and 52 participants (89.7%) in the PPV+APC group. There were no between-group differences in the anatomical closure rate or functional outcomes including best-corrected visual acuity, metamorphopsia, pattern-reversal visual evoked potential, or Visual Function Questionnaire-25 score. The use of APC injection does not improve the anatomical and functional outcomes of surgery for large MHs, recurrent MHs, or MHs with high myopia. The adjunctive use of APC can be considered in selected cases because it is not inferior to conventional MH surgery, is relatively simple to perform, and is not affected by the surgeon’s skill.

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