ArticleTrials2020
The direct superior approach versus posterior approach for total hip arthroplasty: study protocol for a prospective double-blinded randomised control trial.
Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04191993 (A Prospective Randomised Controlled Trial Comparing the Direct Superior Approach Versus the Posterior Approach for Total Hip Arthroplasty), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective Randomised Controlled Trial Comparing the Direct Superior Approach Versus the Posterior Approach for Total Hip Arthroplasty
Who cites it
1 citing paper in PubMed.
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe direct superior approach (DSA) is a minimally invasive modification of the posterior approach (PA) that preserves the iliotibial band and short external rotators except for the piriformis or conjoint tendon during total hip arthroplasty (THA). The objective of this study is to compare patient satisfaction, functional outcomes, accuracy of implant positioning, component stability, gait, cost-effectiveness, and complications in the DSA versus PA for THA. METHODS AND ANALYSIS: This prospective double-blinded randomised control trial will include 80 patients with symptomatic hip osteoarthritis undergoing primary THA. Following informed consent, patients will be randomised to THA using the PA (control group) or DSA (investigation group) at a ratio of 1:1 using an online random number generator. Blinded observers will review patients at regular intervals for 2 years after surgery to record predefined study outcomes relating to postoperative rehabilitation, clinical progress, functional outcomes, accuracy of implant positioning, gait analysis on force plate treadmill, implant migration with radiosteriometric analysis, cost-effectiveness, and complications. A superiority study design will be used to evaluate whether the DSA provides improved outcomes compared to the PA for THA. Evaluation of study outcomes in DSA and PA will be used to quantify and draw inferences on differences in the efficacy of treatment between the two groups. Intention-to-treat and per-protocol population analysis will be undertaken. The following statistical methods will be employed to analyse the data: descriptive statistics, independent t test, paired t test, analysis of variance, Fisher exact test, chi-square test, and graphical displays. Ethical approval was obtained from the London-Fulham Research Ethics Committee, UK. The study is sponsored by University College London, UK. DISCUSSION: This study compares a comprehensive and robust range of clinical, functional, and radiological outcomes in THA performed using the PA versus DSA. The findings of this study will provide an improved understanding of the differences in the PA versus DSA for THA with respect to patient satisfaction, functional outcomes, implant survivorship, gait, cost-effectiveness, and complications.
trial registrationClinicalTrials.gov, NCT04191993. Registered on 10 December 2019.
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