Tibial Baseplate Migration Is Not Associated with Change in Patient-Reported Outcome Measures and Clinical Scores After TKA: A Secondary Analysis of 5 Radiostereometric Analysis Studies with 10-Year Follow-up.

Abstract

Background: Radiostereometric analysis (RSA) provides highly accurate data about the migration of a total knee arthroplasty (TKA) component. However, patient-reported outcome measures (PROMs) reflect the patients' perspective of their functional status, pain, and overall health after TKA. The aim of this study was to evaluate the association between tibial implant migration and change in postoperative PROMs and clinical scores, using data pooled from long-term follow-up RSA studies.

Methods: Individual implant migration data were collected from 5 randomized RSA studies, including a total of 300 patients with 6 distinct TKA implant designs (all Stryker). Tibial implant migration (maximum total point motion [MTPM]) was evaluated with RSA at 3 months, 1 year, and 2, 5, 7, and 10 years postoperatively. The Knee Society Score (KSS)-Knee and KSS-Function and Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales were collected in all studies at the same follow-up times. Linear mixed-effects models, with adjustment for TKA implant design and patient characteristics, were used to analyze the data. The 3-month follow-up visit was used as the baseline to assess the association between implant migration and PROMs across the 10-year follow-up.

Results: No association between tibial implant migration and change in KSS-Knee (p = 0.384), KSS-Function (p = 0.737), KOOS-Symptoms (p = 0.398), KOOS-Pain (p = 0.699), KOOS-Activities of Daily Living (p = 0.205), KOOS-Sport and Recreation (p = 0.702), or KOOS-Quality of Life (p = 0.368) was found across the entire follow-up. Similar results were found when using the 2-year follow-up as the baseline, after which both cemented and uncemented implants are expected to have stabilized.

Conclusions: Tibial baseplate migration was not associated with postoperative worsening in PROMs or clinical scores in patients who underwent TKA. These findings suggest that implant migration, as measured with RSA, measures a different parameter (i.e., implant-bone fixation) than PROMs (i.e., patient perception) and clinical scores. Therefore, to assess the performance and safety of TKA implant designs, RSA and PROMs cannot be used interchangeably during the postoperative follow-up of patients and evaluation of the fixation of knee implants.

Level of evidence: Prognostic Level III . See Instructions for Authors for a complete description of levels of evidence.