Analysis of Patient Outcome Questionnaire Following Primary Knee Replacement

NCT03132077 | Completed DMC

• 1 other identifier: usalford- retrospective
• Study Type: observational
• Target: 1,301
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (3)

• 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

• 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

Study Arms (1)

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

Interventions

total knee arthroplasty PROCEDURE

surgical intervention for end stage of knee osteoarthritis

Also known as: total knee replacement surgery

satisfaction post total knee arthroplasty

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Salford: lead
• Stockport NHS Foundation Trust: collaborator

Study Sites (1)

Stockport NHS Foundation Trust

Stockport, Manchester, SK2 7JE, United Kingdom

Location

Related Publications (12)

• Bade MJ, Wolfe P, Zeni JA, Stevens-Lapsley JE, Snyder-Mackler L. Predicting poor physical performance after total knee arthroplasty. J Orthop Res. 2012 Nov;30(11):1805-10. doi: 10.1002/jor.22140. Epub 2012 Apr 26.

  PMID: 22539338 BACKGROUND

• Brown K, Kachelman J, Topp R, Quesada PM, Nyland J, Malkani A, Swank AM. Predictors of functional task performance among patients scheduled for total knee arthroplasty. J Strength Cond Res. 2009 Mar;23(2):436-43. doi: 10.1519/JSC.0b013e318198fc13.

  PMID: 19197199 BACKGROUND

• Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A, Beard DJ. Knee replacement. Lancet. 2012 Apr 7;379(9823):1331-40. doi: 10.1016/S0140-6736(11)60752-6. Epub 2012 Mar 6.

  PMID: 22398175 BACKGROUND

• Cohen, J. (1988). Statistical Power Analysis for the Behavioral Sciences USA: LAWRENCE ERLBAUM ASSOCIATES.

  BACKGROUND

• Field, A. (2009). Discovering Statistics Using SPSS: SAGE Publications Ltd,.

  BACKGROUND

• Hossain FS, Konan S, Patel S, Rodriguez-Merchan EC, Haddad FS. The assessment of outcome after total knee arthroplasty: are we there yet? Bone Joint J. 2015 Jan;97-B(1):3-9. doi: 10.1302/0301-620X.97B1.34434.

  PMID: 25568406 BACKGROUND

• Jagger, C., Matthews, R., Spiers, N., Brayne, C., Comas - Herrera, A., Robinson, T., . . . Croft, P. (2006). Compression or expansion of disability?: forecasting future disability levels under changing patterns of diseases: King's Fund.

  BACKGROUND

• Klit J, Jacobsen S, Rosenlund S, Sonne-Holm S, Troelsen A. Total knee arthroplasty in younger patients evaluated by alternative outcome measures. J Arthroplasty. 2014 May;29(5):912-7. doi: 10.1016/j.arth.2013.09.035. Epub 2013 Oct 1.

  PMID: 24269097 BACKGROUND

• Lungu E, Desmeules F, Dionne CE, Belzile EL, Vendittoli PA. Prediction of poor outcomes six months following total knee arthroplasty in patients awaiting surgery. BMC Musculoskelet Disord. 2014 Sep 8;15:299. doi: 10.1186/1471-2474-15-299.

  PMID: 25201448 BACKGROUND

• Noiseux NO, Callaghan JJ, Clark CR, Zimmerman MB, Sluka KA, Rakel BA. Preoperative predictors of pain following total knee arthroplasty. J Arthroplasty. 2014 Jul;29(7):1383-7. doi: 10.1016/j.arth.2014.01.034. Epub 2014 Feb 7.

  PMID: 24630598 BACKGROUND

• Patel A, Pavlou G, Mujica-Mota RE, Toms AD. The epidemiology of revision total knee and hip arthroplasty in England and Wales: a comparative analysis with projections for the United States. A study using the National Joint Registry dataset. Bone Joint J. 2015 Aug;97-B(8):1076-81. doi: 10.1302/0301-620X.97B8.35170.

  PMID: 26224824 BACKGROUND

• Portney, L., & Watkins, M. (2009). Foundations of Clinical Research: Applications to Practice. London: Pearson/Prentice Hall, 2009.

  BACKGROUND

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator -PhD student at University of Salford

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 27, 2017
• Study Start: November 1, 2017
• Primary Completion: January 30, 2019
• Study Completion: March 15, 2020
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)