Analysis of Patient Outcome Questionnaire Following Primary Knee Replacement

May 25, 2020 updated by: Bodor Bin sheeha, University of Salford

Retrospective Analysis of Patient Outcome Questionnaire Following Primary Knee Replacement

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1301

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Manchester
      • Stockport, Manchester, United Kingdom, SK2 7JE
        • Stockport NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The inclusion of a minimum of 400 patient records-comprising both males and females-is planned, to achieve 80% power to detect associations between preoperative factors and post-TKA outcomes at the 5% level and a correlation coefficient of 0.2. This will explore the prediction factors that account for more than 4% of outcome variation, that less than oxford knee score clinically detectable changes (Cohen, 1988).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
satisfaction post total knee arthroplasty
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.
Procedure: total knee arthroplasty
surgical intervention for end stage of knee osteoarthritis
Other Names:
  • total knee replacement surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1-3 years post total knee arthroplasty

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Patient's Report Outcome Measures- University of California Los Angeles (UCLA) activity 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 University of California Los Angeles (UCLA) activity score as patients report outcome measures at Stepping Hill Hospital, Stockport
1-3 years post total knee arthroplasty
Changes in Patient's Report Outcome Measures -EQ-5D general health questionnaire - 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 EQ-5D general health questionnaire as patients report outcome measures at Stepping Hill Hospital, Stockport
1-3 years post total knee arthroplasty
Changes in Patient's Report Outcome Measures - visual analogue scales (VAS) - 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 visual analogue scales (VAS) as patients report outcome measures at Stepping Hill Hospital, Stockport
1-3 years post total knee arthroplasty

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Salford

Collaborators

Stockport NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

January 30, 2019

Study Completion (Actual)

March 15, 2020

Study Registration Dates

First Submitted

April 11, 2017

First Submitted That Met QC Criteria

April 24, 2017

First Posted (Actual)

April 27, 2017

Study Record Updates

Last Update Posted (Actual)

May 27, 2020

Last Update Submitted That Met QC Criteria

May 25, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • usalford- retrospective

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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