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临床试验/NCT03558217
NCT03558217已完成不适用

Comparing Direct Anterior and Lateral Surgical Approaches for Collared and Collarless Implants and Correlating Joint Motion to Hip Implant Performance

Lawson Health Research Institute2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2018年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
96
试验地点
2
主要终点
Implant Migration

研究概览

简要总结

This is a randomized control trial that will investigate whether a collared hip replacement implant provides greater stability compared to a collarless option. Stability will be measured by implant migration with radiostereometric analysis (RSA) imaging. Secondary objectives will be to compare function, quality of life and cost between the two implant types. We will also compare between two different surgical approaches, the direct anterior and direct lateral.

详细描述

Total hip arthroplasty (THA) is a procedure that has been demonstrated to provide excellent patient satisfaction and improve quality of life while being cost effective. The number of THA's conducted worldwide is expected to continue to grow; in some projections to grow exponentially. However, the environment for health care continues to evolve. Patients continue to demand higher activity levels, decreased recovery times, and greater patient autonomy. Health care economics are increasingly influencing clinical decision making. Bundled health care payments and more stringent evaluations are becoming the norm. Changes in care pathways based on patient input as well as due to health care economics are our new reality.

These two pervasive forces of change have led to a variety of care challenges and thought leaders have proposed solutions to these challenges. One solution that has responded to both changing patient expectations in their THA experience as well as the economic pressures has been rapid recovery pathways. An increase in rapid recovery care pathways and the growing prevalence of outpatient surgery and surgi-centers has enabled patients to increase their autonomy as well as decrease their time away from activities that are important to them such as employment. Rapid recovery care pathways also provide substantial cost savings by diminishing or eliminating inpatient care as well as enabling improved bed management options.

To facilitate rapid recovery programs, a variety of surgical changes have been made. Improved peri-operative care, decreased muscle trauma, improved hemostasis, and multi-modal analgesia have all made positive impacts. The increasing adaptation of the Direct Anterior Approach (DAA) relative to the Direct Lateral Approach (DLA) can be seen as a response to the need for rapid recovery programs as DAA has been demonstrated to enable earlier function and is thought to result in better patient outcomes, less pain, and shorter recovery times. Orthopaedic industry partners have also supported this change in practice by providing improved instrumentation and technologies to potentiate this minimal invasive surgical approach. A key change is the increasing use of implants that facilitate muscle sparing approaches: femoral components that do no require straight femoral reamers as well as broaches and implants with design features such as an angled lateral shoulder, abbreviated stem lengths, easy to control stem tips, and stems that do not require aggressive impaction to create intimate cortical contact. The Corail both has these features that potentiate surgery as well as excellent survivorship on registry and prospective studies.

In addition to the design features that potentiate minimally invasive implantation, the Corail stem has two main designs - the collared and collarless versions. Without question, the collar provides improved axial stability, and it has also been shown to provide improved rotational stability. It is unclear if this stability enables improved early function by providing the patient the sense that their implant is more stable immediately after surgery. Clinicians also appreciate the ability to more precisely control leg length during THA by ensuring the appropriate leg length is maintained when the collar abuts the calcar. The collar is felt to enable greater initial stability to the hip and provide the surgeon with greater confidence that the patient can embark on a rapid recovery care pathway.

However, not all surgeons are as supportive of implants that have a collar nor are they supportive of implants that have a collar, and highlight a lack of literature that is able to demonstrate the benefits. A lack of literature makes it a challenge for surgeons to adopt the change in philosophy. The purpose of this study is to examine the role of surgical approach and implant design on activity and implant fixation following THA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants will be blinded to which group they have been assigned to until the final study visit at which point study personnel will reveal the group allocation.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • unilateral hip osteoarthritis
  • primary total hip arthroplasty

排除标准

  • symptomatic osteoarthritis in the contralateral hip
  • bilateral total hip arthroplasty
  • revision arthroplasty
  • cognitive defects/neuromuscular disorders
  • inability to understand English (questionnaires are only provided in English)
  • live more than 100km from London, Ontario
  • BMI greater than 40

结局指标

主要结局

Implant Migration

时间窗: 2 years

Movement of the implant measured by radiostereometric imaging analysis.

次要结局

  • Timed-Up-and-Go (TUG) Test(baseline and 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years)
  • University of California, Los Angeles (UCLA) Activity Score(baseline and 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years)
  • Activity Level(baseline and 2 weeks, 4 weeks, 6 weeks, 3 months, 6 months, 1 year and 2 years)
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(baseline and 3 months, 6 months, 1 year and 2 years)
  • Harris Hip Score(baseline and 3 months, 6 months, 1 year and 2 years.)
  • Cost Questionnaires(6 weeks, 3 months, 6 months and 1 year)
  • 12-Item Short Form Health Survey (SF-12)(baseline and 3 months, 6 months, 1 year and 2 years)
  • EuroQol-5D (EQ-5D)(baseline and 6 weeks, 3 months, 6 months and 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brent Lanting

Orthopaedic Surgeon

Lawson Health Research Institute

研究点 (2)

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