ArticleJB & JS open access
Early Functional Outcomes After Evolutionary Total Knee Arthroplasty: A Randomized Controlled Trial. Is New Always Better?
Article in JB & JS open access. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 9 citations in OpenAlex.
- Patient-reported outcomes and complications of a new-generation total knee system: a randomized controlled trial.Acta orthopaedica · 2025Trial
- Effect of femoral component design and quadriceps load on patellofemoral kinematics after total knee arthroplasty: an in vitro cadaveric study.Knee surgery & related research · 2026Article
- Comparison of postoperative clinical outcome in medial-pivotal and gradually reducing radius design cruciate-retaining total knee arthroplasty-A multicenter analysis of propensity-matched cohorts.Journal of experimental orthopaedics · 2024Article
- Medial tibial bone resorption following total knee arthroplasty comparing a traditional with a kinematic design.Archives of orthopaedic and trauma surgery · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Total knee replacement (TKR) designs continue to evolve with the aim of improving patient outcomes; however, there remains a significant patient dissatisfaction rate. We report the early functional outcomes of an evolutionary knee design in the context of a single-blinded, noninferiority, randomized controlled trial.
methodsPatients were randomized to receive either the P.F.C. SIGMA or ATTUNE knee implant systems (DePuy Synthes). All implants were fixed-bearing, cruciate-retaining, and cemented constructs. Patients were assessed at baseline and 6 weeks, 3 months, and 1 year postoperatively using clinical and functional outcome measures, including range of motion, Oxford Knee Score (OKS), Oxford Knee Score-Activity and Participation Questionnaire (OKS-APQ), Patient Knee Implant Performance (PKIP) score, 5-Level EuroQol 5 Dimensions (EQ-5D-5L), and Short Form-36 outcome measures.
resultsThere were 150 patients who underwent a surgical procedure (76 with the ATTUNE implant and 74 with the P.F.C. SIGMA implant), with 147 patients remaining at the final review. No differences were observed in any of the outcome measures between the groups at any time point. Tourniquet time was significantly shorter in the P.F.C. SIGMA arm (p = 0.001); however, this had no clinical impact on the OKS (analysis of covariance [ANCOVA] test) at the final review (p = 0.825). There was no difference in the numbers of patients achieving the minimal clinically important difference for the OKS between the groups (p = 0.817).
conclusionsThis trial did not show inferiority of the ATTUNE implant when compared with the P.F.C. SIGMA implant. The authors believe that implant innovation should continue and that modern implants should be introduced into the market following randomized controlled trials. Further work should assess the effect of non-implant-related factors on patient outcomes. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.