Dataset Information

A prospective randomized trial of mini-incision posterior and two-incision total hip arthroplasty.

ABSTRACT: The two-incision approach to THA has been controversial, with some authors reporting its use is associated with a rapid recovery whereas others report no differences in outcomes and a higher risk of perioperative complications secondary to increased surgical complexity.We therefore compared early postoperative variables including pain, length of stay, functional recovery, complications, and complexity of the mini-posterior and two-incision approaches to THA.We prospectively enrolled 72 patients scheduled for THA and randomized them into two groups: mini-incision posterior approach and the two-incision approach. Preoperative teaching, anesthetic protocols, implants used, and rehabilitation pathways were identical for both groups. All variables were assessed at a maximum of 1 year postoperatively.All key outcomes were similar in the two groups: mean visual analog scale (VAS) scores for pain during the first 3 postoperative days and the first 6 weeks, total narcotic requirements in the hospital and during the first 6 weeks, mean length of stay (51 hours versus 48 hours), and mean Harris hip scores and SF-12 scores. Achievement of functional milestones was similar between the two groups. There was one reoperation in each group. Mean operative time was longer for patients in the two-incision group (98 minutes versus 77 minutes), however the accuracy of component positioning was similar.We found no differences in perioperative outcomes between these two approaches for THA. Variables other than the surgical approach including perioperative protocols, patient expectations, and the patient's general health may have a greater effect on outcomes such as pain during the early postoperative period, functional recovery, and length of hospital stay. The use of small incisions for THA was safe as was a shortened hospital stay in selected patients.

SUBMITTER: Della Valle CJ

PROVIDER: S-EPMC2974893 | biostudies-literature | 2010 Dec

REPOSITORIES: biostudies-literature

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A prospective randomized trial of mini-incision posterior and two-incision total hip arthroplasty.

Della Valle Craig J CJ Dittle Emily E Moric Mario M Sporer Scott M SM Buvanendran Asokumar A

Clinical orthopaedics and related research 20100729 12

<h4>Background</h4>The two-incision approach to THA has been controversial, with some authors reporting its use is associated with a rapid recovery whereas others report no differences in outcomes and a higher risk of perioperative complications secondary to increased surgical complexity.<h4>Questions/purposes</h4>We therefore compared early postoperative variables including pain, length of stay, functional recovery, complications, and complexity of the mini-posterior and two-incision approaches ...[more]

PMID: 20668969

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Project description: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 analysisThis 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.DiscussionThis 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.

Project description:Despite the growing evidence in the literature there is still a lack of consensus regarding the use of minimally invasive surgical technique (MIS) in total knee arthroplasty (TKA).A prospective, randomized, international multicentre trial including 69 patients was performed to compare computer-assisted TKA (CAS-TKA) using either mini-midvastus (MIS group) or standard medial parapatellar approach (conventional group). Patients from 3 centers (Maastricht, Zwickau, Adelaide) with end-stage osteoarthritis of the knee were randomized to either an MIS group with dedicated instrumentation or a conventional group to receive cruciate retaining CAS-TKA without patella resurfacing. The primary outcome was to compare post operative pain and range of motion (ROM). The secondary outcome was to measure the duration of surgery, blood loss, chair rise test, quadriceps strength, anterior knee pain, Knee Society Score (KSS),WOMAC scores, mechanical leg axis and component alignment.Patients in the MIS group (3.97?±?2.16) had significant more pain at 2 weeks than patients in the conventional group (2.77?±?1.43) p?=?0.003. There was no significant difference in any of the other primary outcome parameters. Surgery time was significantly longer (p?<?0.001) and there were significantly higher blood loss (p?=?0.002) in the MIS group as compared to the conventional group. The difference of the mean mechanical leg alignment between the groups was not statistically significant (-0.43° (95% CI -1.50-0.64); p?=?0.43). There was no significant difference of component alignment between the two surgical groups with respect to flexion/extension (p?=?0.269), varus/valgus (p?=?0.653) or rotational alignment (p?=?0.485) of the femur component and varus valgus alignment (p?=?0.778) or posterior slope (p?=?0.164) of the tibial component.There was no advantage of the MIS approach compared to a conventional approach CAS-TKA in any of the primary outcome measurements assessed, however the MIS approach was associated with longer surgical time and greater blood loss. MIS-TKA in combination with computer navigation is safe in terms of implant positioning.ClinicalTrials.gov NCT02625311 8 December 2015.

Project description:BACKGROUND:Robotic-arm assisted surgery aims to reduce manual errors and improve the accuracy of implant positioning during total hip arthroplasty. The objective of this study is to compare the accuracy of implant positioning, restoration of hip biomechanics, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications in conventional manual total hip arthroplasty (CO THA) versus robotic-arm assisted total hip arthroplasty (RO THA). Preoperative pelvic computerised tomography (CT) scans will be used to create patient-specific, virtual, three-dimensional reconstructions for surgical planning in both treatment groups. METHODS AND ANALYSIS:This prospective randomised controlled trial will include 60 patients with symptomatic hip osteoarthritis undergoing primary THA. Following informed consent, patients will be randomised to CO THA (control group) or RO THA (investigation group) at a ratio of 1:1 using an online random number generator. Observers will review patients at regular intervals for 2 years after surgery to record predefined study outcomes relating to the accuracy of implant positioning, hip biomechanics, postoperative rehabilitation, clinical progress, functional outcomes, cost-effectiveness, and complications. Primary and secondary objectives 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. Intention to treat relates to the allocated treatment (CO THA or RO THA), and per-protocol refers to the actual treatment received by the patient. 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-Bromley 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 CT-planned CO THA versus CT-planned RO THA. The findings of this study will enable an improved understanding of the differences in CO THA versus RO THA with respect to patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications. TRIAL REGISTRATION:ClinicalTrials.gov NCT04095845 . Registered on 19 September 2019.

Dataset Information

A prospective randomized trial of mini-incision posterior and two-incision total hip arthroplasty.

Publications

A prospective randomized trial of mini-incision posterior and two-incision total hip arthroplasty.

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