Rationale for and Methods of Superiority, Noninferiority, or Equivalence Designs in Orthopaedic, Controlled Trials

Vavken, Patrick

doi:10.1007/s11999-011-1773-6

Cited by 27 publications

(20 citation statements)

References 50 publications

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“…Age squared was entered to achieve a satisfactory model fit. A non-inferiority test based on the absolute risk difference was performed, applying a 1% non-inferiority margin ( Vavken 2011 ). In this case, the null hypothesis was an absolute increase in risk of 1% or more in the regime without restrictions.…”

Section: Methodsmentioning

confidence: 99%

Removal of restrictions following primary THA with posterolateral approach does not increase the risk of early dislocation

Gromov¹,

Troelsen²,

Otte³

et al. 2015

Acta Orthopaedica

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Background and purpose Patient education and mobilization restrictions are often used in an attempt to reduce the risk of dislocation following primary THA. To date, there have been no studies investigating the safety of removal of mobilization restrictions following THA performed using a posterolateral approach. In this retrospective non-inferiority study, we investigated the rate of early dislocation following primary THA in an unselected patient cohort before and after removal of postoperative mobilization restrictions.Patients and methods From the Danish National Health Registry, we identified patients with early dislocation in 2 consecutive and unselected cohorts of patients who received primary THA at our institution from 2004 through 2008 (n = 946) and from 2010 through 2014 (n = 1,329). Patients in the first cohort were mobilized with functional restrictions following primary THA whereas patients in the second cohort were allowed unrestricted mobilization. Risk of early dislocation (within 90 days) was compared in the 2 groups and odds ratio (OR)—adjusted for possible confounders—was calculated. Reasons for early dislocation in the 2 groups were identified.Results When we adjusted for potential confounders, we found no increased risk of early dislocation within 90 days in patients who were mobilized without restrictions. Risk of dislocation within 90 days was lower (3.4% vs 2.8%), risk of dislocation within 30 days was lower (2.1% vs 2.0%), and risk of multiple dislocations (1.8% vs 1.1%) was lower in patients who were mobilized without restrictions, but not statistically significantly so. Increasing age was an independent risk factor for dislocation.Interpretation Removal of mobilization restrictions from the mobilization protocol following primary THA performed with a posterolateral approach did not lead to an increased risk of dislocation within 90 days.

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Section: Methodsmentioning

confidence: 99%

Removal of restrictions following primary THA with posterolateral approach does not increase the risk of early dislocation

Gromov¹,

Troelsen²,

Otte³

et al. 2015

Acta Orthopaedica

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“…Treatment groups demonstrated a difference in the BMD that was less than 25% of the standard deviation (SD) within groups and differences in bone biomarkers that were less than 10% of the SD within groups. With the significance level of 0.05 (according to recommendations for non‐inferiority trials), the sample size in this study was considered to have proper strength.…”

Section: Discussionmentioning

confidence: 99%

Influence of Ibuprofen on Bone Healing After Colles' Fracture: A Randomized Controlled Clinical Trial

Aliuskevicius

Østgaard

Hauge

et al. 2019

Journal Orthopaedic Research

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Non‐steroidal anti‐inflammatory drugs (NSAIDs) may delay bone healing. [Therefore, it is important to establish whether NSAID preparations delay bone healing and what correlations, if any, exist between different bone studies—DEXA—scanning, bone markers, roentgenology controls, and histological examination of newly formed bone]. The purpose of this prospective controlled study was to investigate whether ibuprofen affects bone mineral density, turnover biomarkers, and histomorphometric characteristics of the callus after a Colles' fracture. This study was a single‐center, triple‐blinded, randomized clinical trial. Ninety‐five patients (80 females) with displaced Colles' fracture, median age 65 (range 40–85) years were included in the study and operated on by external fixation from June 2012 through to June 2015. Eighty‐nine patients received interventional medicine and 83 completed the 1‐year follow‐up. The 7‐day ibuprofen group received 600 mg of ibuprofen three times a day (N = 29), the 3‐day ibuprofen group received ibuprofen for 3 days (N = 30) and a placebo for the following 4 days, and finally, the placebo group received a placebo for 7 days (N = 30). The primary outcome was the difference in bone mineral density between the ultra‐distal region of the injured and non‐injured radius at 3 months after surgery. The histomorphometric outcomes included the assessment of callus tissue volume and surface fractions at 6 weeks postoperatively. The biomarkers Osteocalcin and CrossLaps were measured at baseline, 1 week, 2 weeks, 6 weeks, 3 months, and 1 year. We included the results of the dropped‐out patients in the intention to treat analysis. There was no difference between treatment groups in bone mineral density, histomorphometric estimations, and changes in bone biomarkers. These findings may offer an indication of ibuprofen as a bone‐safe analgesic treatment in an acute fracture‐phase. © 2019 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 38:545–554, 2020

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“…Therefor we chose a non-inferiority design to compare the two different treatments [15]. Since there is hardly any prior data on the comparative effectiveness, or safety, of pre-versus postoperatively administered thrombo -prophylaxis, it was extremely difficult to define a statistically valid and clinically relevant non-inferiority margin.…”

Section: Discussionmentioning

confidence: 99%

“…This study was designed as an active-controlled non-inferiority trial to assess the effectiveness and safety of thromboembolic prophylaxis with Bemiparin Sodium treatment started pre-or postoperatively in patients undergoing opening the spinal canal [15]. Furthermore, we searched for correlations between secondary diagnoses and a thrombotic event or any kind of complication.…”

Section: Methodsmentioning

confidence: 99%

A Prospective, Active-control, Non-inferiority Study of the Effectiveness of Low Molecular Weight Heparin in the Prophylaxis of Postoperative Thrombotic Events in Patients Undergoing Spinal Surgery

Patrick¹

2015

Orthop Muscul Syst

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Background: The Incidence of verified thrombotic events after elective spine surgery is 18%. Low-Molecular-Weight-Heparin (LMWH) is routinely given on the day before surgery. A postoperative start of the thrombotic prophylaxis could be an advantage in cases with opening of the spinal canal and for preventing epidural bleeding. Patient and methods: This active-controlled non-inferiority trial compared the effectiveness and safety of LMWH started pre-or postoperatively in patients undergoing spinal surgery. We analysed the incidence of clinically symptomatic venous thromboembolism. Results: A total number of 241 patients were followed over 14.6 patient-years. The incidence risk of fatal thromboembolisms was 0.011 (95%CI 0.0003 to 0.06) for the group with preoperative treatment and 0.01 (95% CI 0.0002 to 0.04) for the postoperatively treated group. The crude risk ratio was 1.65 (95%CI 0.10 to 26.03). There was no statistically significant difference in risk across groups (p=0.72). The Poisson regression model including follow-up time showed an incidence rate ratio of 0.67 (95% 0.04 to 10.74, p=0.779). There was no increased risk for complications (p=0.211). Conclusion: This study demonstrates that the postoperative start of LMWH in the prophylaxis of thrombotic events in patients undergoing spinal surgery does not affect safety or the incidence of complications.

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Rationale for and Methods of Superiority, Noninferiority, or Equivalence Designs in Orthopaedic, Controlled Trials

Cited by 27 publications

References 50 publications

Removal of restrictions following primary THA with posterolateral approach does not increase the risk of early dislocation

Removal of restrictions following primary THA with posterolateral approach does not increase the risk of early dislocation

Influence of Ibuprofen on Bone Healing After Colles' Fracture: A Randomized Controlled Clinical Trial

A Prospective, Active-control, Non-inferiority Study of the Effectiveness of Low Molecular Weight Heparin in the Prophylaxis of Postoperative Thrombotic Events in Patients Undergoing Spinal Surgery

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