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Published in: Trials 1/2020

Open Access 01-12-2020 | Hip-TEP | Study protocol

The direct superior approach versus posterior approach for total hip arthroplasty: study protocol for a prospective double-blinded randomised control trial

Authors: Babar Kayani, Sujith Konan, Jenni Tahmassebi, Atif Ayuob, Fares S. Haddad

Published in: Trials | Issue 1/2020

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Abstract

Background

The 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 registration

ClinicalTrials.gov, NCT04191993. Registered on 10 December 2019
Literature
1.
Amanatullah DF, Masini MA, Roger DJ, et al. Greater inadvertent muscle damage in direct anterior approach when compared with the direct superior approach for total hip arthroplasty. Bone Joint J. 2016;98-b(8):1036–42.CrossRef
2.
Barrack RL, Krempec JA, Clohisy JC, et al. Accuracy of acetabular component position in hip arthroplasty. J Bone Joint Surg Am. 2013;95(19):1760–8.CrossRef
3.
Barrack RL, Paprosky W, Butler RA, et al. Patients’ perception of pain after total hip arthroplasty. J Arthroplast. 2000;15(5):590–6.CrossRef
4.
Berger RA. Total hip arthroplasty using the minimally invasive two-incision approach. Clin Orthop Relat Res. 2003;417:232–41.
5.
Bergin PF, Doppelt JD, Kephart CJ, et al. Comparison of minimally invasive direct anterior versus posterior total hip arthroplasty based on inflammation and muscle damage markers. J Bone Joint Surg Am. 2011;93(15):1392–8.CrossRef
6.
Biedermann R, Tonin A, Krismer M, et al. Reducing the risk of dislocation after total hip arthroplasty: the effect of orientation of the acetabular component. J Bone Joint Surg (Br). 2005;87(6):762–9.CrossRef
7.
Bremer AK, Kalberer F, Pfirrmann CW, et al. Soft-tissue changes in hip abductor muscles and tendons after total hip replacement: comparison between the direct anterior and the transgluteal approaches. J Bone Joint Surg (Br). 2011;93(7):886–9.CrossRef
8.
Fehring TK, Mason JB. Catastrophic complications of minimally invasive hip surgery. A series of three cases. J Bone Joint Surg Am. 2005;87(4):711–4.CrossRef
9.
Graham B, Green A, James M, et al. Measuring patient satisfaction in orthopaedic surgery. J Bone Joint Surg Am. 2015;97(1):80–4.CrossRef
10.
Greidanus NV, Chihab S, Garbuz DS, et al. Outcomes of minimally invasive anterolateral THA are not superior to those of minimally invasive direct lateral and posterolateral THA. Clin Orthop Relat Res. 2013;471(2):463–71.CrossRef
11.
Hartzband MA. Posterolateral minimal incision for total hip replacement: technique and early results. Orthop Clin North Am. 2004;35(2):119–29.CrossRef
12.
Kayani B, Konan S, Chandramohan R, et al. The direct superior approach in total hip arthroplasty. Br J Hosp Med (Lond). 2019;80(6):320–4.CrossRef
13.
Kayani B, Konan S, Thakrar RR, et al. Assuring the long-term total joint arthroplasty: a triad of variables. Bone Joint J. 2019;101-b(1_Supple_A):11–8.CrossRef
14.
Lavernia C, D'Apuzzo M, Hernandez VH, et al. Patient-perceived outcomes in thigh pain after primary arthroplasty of the hip. Clin Orthop Relat Res. 2005;441:268–73.CrossRef
15.
Lewinnek GE, Lewis JL, Tarr R, et al. Dislocations after total hip-replacement arthroplasties. J Bone Joint Surg Am. 1978;60(2):217–20.CrossRef
16.
Meermans G, Konan S, Das R, et al. The direct anterior approach in total hip arthroplasty: a systematic review of the literature. Bone Joint J. 2017;99-b(6):732–40.CrossRef
17.
Nam D, Meyer Z, Rames RD, et al. Is the direct superior, iliotibial band-sparing approach associated with decreased pain after total hip arthroplasty? J Arthroplast. 2017;32(2):453–7.CrossRef
18.
Pellicci PM, Bostrom M, Poss R. Posterior approach to total hip replacement using enhanced posterior soft tissue repair. Clin Orthop Relat Res. 1998;355:224–8.CrossRef
19.
Penenberg BL, Bolling WS, Riley M. Percutaneously assisted total hip arthroplasty (PATH): a preliminary report. J Bone Joint Surg Am. 2008;90(Suppl 4):209–20.CrossRef
20.
Poehling-Monaghan KL, Kamath AF, Taunton MJ, et al. Direct anterior versus miniposterior THA with the same advanced perioperative protocols: surprising early clinical results. Clin Orthop Relat Res. 2015;473(2):623–31.CrossRef
21.
Roger DJ, Hill D. Minimally invasive total hip arthroplasty using a transpiriformis approach: a preliminary report. Clin Orthop Relat Res. 2012;470(8):2227–34.CrossRef
22.
Ryd L, Albrektsson BE, Carlsson L, et al. Roentgen stereophotogrammetric analysis as a predictor of mechanical loosening of knee prostheses. J Bone Joint Surg (Br). 1995;77(3):377–83.CrossRef
23.
Selvik G. Roentgen stereophotogrammetry. A method for the study of the kinematics of the skeletal system. Acta Orthop Scand Suppl. 1989;232:1–51.CrossRef
24.
Selvik G, Alberius P, Aronson AS. A roentgen stereophotogrammetric system. Construction, calibration and technical accuracy. Acta Radiol Diagn (Stockh). 1983;24(4):343–52.CrossRef
25.
Timperley AJ, Biau D, Chew D, et al. Dislocation after total hip replacement - there is no such thing as a safe zone for socket placement with the posterior approach. Hip Int. 2016;26(2):121–7.CrossRef
Metadata
Title
The direct superior approach versus posterior approach for total hip arthroplasty: study protocol for a prospective double-blinded randomised control trial
Authors
Babar Kayani
Sujith Konan
Jenni Tahmassebi
Atif Ayuob
Fares S. Haddad
Publication date
01-12-2020
Publisher
BioMed Central
Keywords
Hip-TEP
Hip-TEP
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04484-y

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