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Clinical Trials/NCT03132077
NCT03132077
Completed
Not Applicable

Retrospective Analysis of Patient Outcome Questionnaire Following Primary Knee Replacement

University of Salford1 site in 1 country1,301 target enrollmentNovember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Total Knee Arthroplasty
Sponsor
University of Salford
Enrollment
1301
Locations
1
Primary Endpoint
Changes in Patient's Report Outcome Measures (Oxford knee score) before and after the surgery
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2017
End Date
March 15, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bodor Bin sheeha

Principal Investigator -PhD student at University of Salford

University of Salford

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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