Dataset Information

Early outcomes and predictors of patient satisfaction after TKA: a prospective study of 200 cases with a contemporary cemented rotating platform implant design.

ABSTRACT:

Purpose

The purpose of the study was to identify the earliest time point where subjects realized the greatest clinical improvement after TKA, and the time when post-operative scores became superior to pre-operative scores. Post-hoc exploratory analyses were conducted to investigate predictors of early post-operative outcomes and patient satisfaction.

Methods

Six investigators across 4 sites in the Netherlands prospectively implanted 200 subjects with a contemporary cemented rotating platform device. Patient Reported Outcome Measurements (PROMs) KOOS-PS, PKIP, and EQ-5D were collected pre-operatively and post-operatively through 2-years. PROMs change from pre-operative baseline were summarized, along with radiographic outcomes and adverse events (AEs). Pre-operative patient characteristics were explored for correlation with patient outcomes, and patient satisfaction for correlation with KOOS-PS.

Results

Follow-up compliance was 99% at 6-months, and 95.5% at 2-years. The percentage with higher KOOS-PS compared to baseline was 81.3% at 6-months. KOOS-PS, PKIP, and PKIP subscore means were all better at 6-weeks versus baseline. Gender, BMI, hypertension, and pre-operative KOOS-PS were weakly correlated with 6-week KOOS-PS (multivariate R-squared = 14.1%), but only pre-operative KOOS-PS demonstrated correlation with post-operative KOOS-PS at 6-months or later (R-squared < 5% at 6-months and 2 years). Satisfaction was moderately correlated with concurrent KOOS-PS at each post-operative time point, with (R-squared = 35.3% at 6-months, and 37.5% at 2 years).

Conclusion

The greatest mean clinical improvement occurred within the first 6-weeks. Although some pre-operative factors were correlated with higher early post-operative KOOS-PS outcomes, these advantages disappeared by 6-months aside from weak correlation with pre-operative KOOS-PS. Post-operative KOOS-PS was moderately correlated with concurrent post-operative satisfaction. These results may be used for pre-operative counseling and management of patient's postoperative expectations.

Trial registration

Clinicaltrials.gov, NCT02339610 . Registered 15 January 2015.

SUBMITTER: van Loon C

PROVIDER: S-EPMC8052397 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundMobile bearings have been compared with fixed bearings used in TKA. However, rotating platforms, a specific type of mobile bearing, have not been compared with fixed-bearings using meta-analysis.Questions/purposesWe asked whether the performance of a rotating-platform bearing is superior to, comparable to, or worse than a fixed bearing. Four areas were investigated: clinical performance, component alignment, adverse event rates, and revision rates.MethodsSearches of Medline, EMBASE, Google Scholar, and the Cochrane databases, combined with reference lists from published meta-analyses and systematic reviews of mobile-bearing versus fixed-bearing prostheses used in TKAs, provided 17 nonlanguage-restricted studies consisting of 1910 TKAs (966 rotating platform versus 944 fixed bearing). Random-effect modeling was used for all meta-analyses, thereby mitigating possible effects of heterogeneity among studies. All meta-analyses were examined for publication bias using funnel plots; publication bias was not detected for any meta-analysis.ResultsThere were no statistically or clinically significant differences in clinical performance (clinical scores, ROM, and radiographic evaluation), component alignment, revision rates, or adverse event rates except for tibial component alignment in the AP plane, which favored TKA with fixed-bearings (p = 0.020; standardized mean difference, 0.229; 95% CI, 0.035-0.422), but the effect size was small enough that it was not considered clinically important.ConclusionsBased on our findings, which agree substantially with those of prior systematic reviews of TKAs with mobile-bearing versus fixed-bearing prostheses, there is no compelling case for either rotating-platform or fixed-bearing implant design in terms of clinical performance, component alignment, adverse event frequencies, or survivorship. This dataset, which was limited to a maximum 6 years followup, is insufficient to address questions related to wear or late revisions. We therefore suggest that implant choice should be made on the basis of other factors, perhaps including cost or surgeon experience.