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临床试验/NCT03132077
NCT03132077已完成不适用

Retrospective Analysis of Patient Outcome Questionnaire Following Primary Knee Replacement

University of Salford1 个研究点 分布在 1 个国家目标入组 1,301 人开始时间: 2017年11月1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
1,301
试验地点
1
主要终点
Changes in Patient's Report Outcome Measures (Oxford knee score) before and after the surgery

研究概览

简要总结

The intention is to explore whether there are factors which help us to understand why some patient outcomes are not successful and identify prediction factors for progression. It will also assess the available outcomes pre- and post-surgery may explore prediction tools for good/poor progression and improve the patient's selection, patient preparation or timing for surgery.

The focus of this project is exploring outcomes post-primary total knee arthroplasty (TKA) using the available pre/post-operative Oxford Knee Score (OKS), University of California Los Angeles (UCLA) Activity Score, EQ-5D General Health Questionnaire, Visual Analogue (VAS) for pain, age and smoking status data, and correlations between these data and post operation patient satisfaction.

详细描述

Knee osteoarthritis (OA) is a major cause of disability around the world; it is the most common chronic condition in primary care in the UK. By 2030 it is predicted to be the greatest cause of disability in the general population. An effective end-stage treatment for knee OA is knee-replacement surgery.

In England and Wales, the number of knee-replacement procedures recorded by the National Joint Registry in 2013 was 91,703, which represents an increase of 0.9 % over 2012. The data analysis by the National Joint Registry and the Office of National Statistics suggests that, by 2030, primary TKAs will increase by 117% from the 2012 level. Subsequently, TKA revision surgeries are expected to increase incrementally by 332%.

Post-TKA, 75-85% of patients report satisfaction with surgery outcomes, while the remaining 15-25% are dissatisfied. Total knee arthroplasty's success has traditionally been evaluated from the surgeon's perspective, e.g. the presence of surgical complications or implant survival. This is gradually changing to involve the patient in measuring health outcomes and decision-making processes. Patient-reported outcome measures (PROMs) have evolved to explore patient perspectives by monitoring the quality of care in health organizations and conducting clinical trial outcomes. National Health Service used PROMs to measures health gain in patients undergoing hip replacement, knee replacement, varicose vein and groin hernia surgery in England, based on responses to questionnaires before and after surgery.

This retrospective cohort study will investigate outcomes 1 and 3 years post-TKA, and factors that may predict good/poor progression based on previously gathered data, which may minimize the effect of prospective data collection bias. The study will explore accurate prediction factors of post-TKA satisfaction at Stockport NHS Foundation Trust operates at Stepping Hill Hospital which is a busy District General Hospital, with a large orthopaedic department. Outcome following knee replacement surgery is closely monitored and matches the best performing units in the UK. Potentially, reliable outcome prediction could, however, improve patient selection for surgery, as appropriate timing for surgery depends on patient symptoms and efficient patient preparation for surgery if it is to be cost-effective. Accurate preoperative prediction is crucial to minimize the potential for unrealistic expectations which may improve their satisfaction.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • The present study is a retrospective randomised analysis of outcomes 1 years post-TKA.
  • All individuals have previously consented to give access to their data for research studies.
  • All patients' records prospectively gathered data spanning more than 3 years will be reviewed, if they were scheduled for primary unilateral TKA for end-stage knee osteoarthritis and were in a stable and controlled medical condition at Stepping Hill Hospital.
  • The records will be considered eligible if the following criteria are met:
  • At least one preoperative record no more than 6 months prior to the surgery, 1-year postoperative records available.
  • In regards to the questionnaires, (OKS, UCLA and EQ-5D), a maximum of one missing question for UCLA and two for OKS questionnaire.

排除标准

  • Potential research records were excluded from the study if;
  • The patient had more than acceptable missing datum for any outcome score.
  • The patient did not consent to the use of their records for research purposes.
  • No preoperative record or the postoperative records not available.

结局指标

主要结局

Changes in Patient's Report Outcome Measures (Oxford knee score) before and after the surgery

时间窗: 1-3 years post total knee arthroplasty

To explore factors which may help us understand why some patient outcomes are not successful and identify factors associated with poor satisfaction using Oxford knee score (OKS) as patients report outcome measures at Stepping Hill Hospital, Stockport

次要结局

  • Changes in Patient's Report Outcome Measures -EQ-5D general health questionnaire - before and after the surgery(1-3 years post total knee arthroplasty)
  • Changes in Patient's Report Outcome Measures - visual analogue scales (VAS) - before and after the surgery(1-3 years post total knee arthroplasty)
  • Changes in Patient's Report Outcome Measures- University of California Los Angeles (UCLA) activity score- before and after the surgery(1-3 years post total knee arthroplasty)

研究者

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

Bodor Bin sheeha

Principal Investigator -PhD student at University of Salford

University of Salford

研究点 (1)

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