A comparison of patient reported outcome measures following total knee replacement with either the Depuy Synthes AttuneTM or Depuy Synthes PFCTM total knee replacement systems: A single blinded randomised controlled trial study protocol

Abstract

Introduction: Total knee arthroplasty is a successful procedure with excellent clinical outcomes although a 15 % dissatisfaction rate remains. Design differences between knee prostheses continue to be developed in an effort to improve these outcomes. We aimed to design a study to evaluate the effect of these design features on the functional and clinical outcomes following total knee arthroplasty. Methods:We have designed a single blinded randomised controlled trial to evaluate outcomes comparing two different knee replacement prostheses. We will randomise 150 patients to undergo a total knee replacement with either the DePuy Synthes AttuneTM or the DePuy Synthes PFC SigmaTM cruciate retaining systems. There will be 75 patients in each arm. Preoperative and postoperative patient reported outcome measures (PROMS) data will be recorded together with clinical outcomes including range of movement and complication rates. The primary end point will be functional and clinical outcomes at one year post surgery.All analyses shall be carried out on an intention to treat basis, retaining patients in their initial treatment groups irrespective of any protocol violations. Missing data are anticipated to be small and primary analysis will be carried out on a complete case basis. All analyses shall be evaluated using a two-sided hypothesis test, assessing all P-value at the 0.05 level with associated 95% confidence intervals.Ethical approval for the study has been sought and obtained from the NRES Committee North West -Greater Manchester South, UK, Reference 14/NW/1330. Discussion: This trial will provide a robust assessment of the clinical and functional differences between two types of knee replacement prostheses by utilising a blinded randomised controlled trial with multiple functional and generic outcome measures and close follow up of the patient cohort.

Early Functional Outcomes After Evolutionary Total Knee Arthroplasty

“…SIGMA and ATTUNE knee implants. The trial protocol was previously published and registered (ISRCTN10345709) 7 . Inclusion and exclusion criteria are illustrated in Table I.…”