Trial reportThe bone & joint journal2020
A randomized controlled trial comparing tibial migration of the ATTUNE cemented cruciate-retaining knee prosthesis with the PFC-sigma design.
Trial report in The bone & joint journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06483178 (A Randomised Controlled Trial Comparing Gait in Fixed or Rotating Cementless Total Knee Arthroplasties), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.
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.
A Randomised Controlled Trial Comparing Gait in Fixed or Rotating Cementless Total Knee Arthroplasties
Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.
- 6-month migration sufficient for evaluation of total knee replacements: a systematic review and meta-analysis.Acta orthopaedica · 2023Pooled it
- No difference in clinical outcome but in RSA in total knee arthroplasty with the ATTUNE vs. the PFC Sigma: a randomized trial with 2-year follow-up.Acta orthopaedica · 2023Trial
- Variation in KOOS JR improvement across total knee implant designs: a cohort study from Michigan Arthroplasty Registry Collaborative Quality Initiative.Acta orthopaedica · 2025Article
- Is there an increased revision rate due to early tibial component loosening with a modern total knee arthroplasty design? A retrospective analysis from a large volume arthroplasty centre.Arthroplasty (London, England) · 2024Article
- Does lucency equate to revision? A five-year retrospective review of Attune and Triathlon total knee arthroplasty.Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA · 2023Article
- Dose reduction does not impact the precision of CT-based RSA in tibial implants: a diagnostic accuracy study on precision in a porcine cadaver.Acta orthopaedica · 2023Article
- Early and mid-term results with the ATTUNE total knee replacement system compared to PFC Sigma: a prospective comparative study.Journal of orthopaedic surgery and research · 2022Article
- Tibial Baseplate-Cement Interface Debonding in the ATTUNE Total Knee Arthroplasty System.Arthroplasty today · 2022Article
- Roentgen stereophotogrammetric analysis: still a very valuable tool in the orthopaedic research armamentarium.Bone & joint research · 2022Article
- Early migration of a medially stabilized total knee arthroplasty : a radiostereometric analysis study up to two years.Bone & joint open · 2021Article
- Loading on Attune® fixed-bearing cruciate-substituting total knee implant in knee malalignment during activities of daily living: A finite element analysis.Journal of orthopaedicsArticle
- Early Functional Outcomes After Evolutionary Total Knee Arthroplasty: A Randomized Controlled Trial. Is New Always Better?JB & JS open accessArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThe primary objective of this study was to compare migration of the cemented ATTUNE fixed bearing cruciate retaining tibial component with the cemented Press-Fit Condylar (PFC)-sigma fixed bearing cruciate retaining tibial component. The secondary objectives included comparing clinical and radiological outcomes and Patient Reported Outcome Measures (PROMs).
methodsA single blinded randomized, non-inferiority study was conducted including 74 patients. Radiostereometry examinations were made after weight bearing, but before hospital discharge, and at three, six, 12, and 24 months postoperatively. PROMS were collected preoperatively and at three, six, 12, and 24 months postoperatively. Radiographs for measuring radiolucencies were collected at two weeks and two years postoperatively.
resultsThe overall migration (mean maximum total point motion (MPTM)) at two years was comparable: mean 1.13 mm (95% confidence interval (CI), 0.97 to 1.30) for the ATTUNE and 1.16 mm (95% CI, 0.99 to 1.35) for the PFC-sigma. At two years, the mean backward tilting was -0.43° (95% CI, -0.65 to -0.21) for the ATTUNE and 0.08° (95% CI -0.16 to 0.31), for the PFC-sigma. Overall migration between the first and second postoperative year was negligible for both components. The clinical outcomes and PROMs improved compared with preoperative scores and were not different between groups. Radiolucencies at the implant-cement interface were mainly seen below the medial baseplate: 17% in the ATTUNE and 3% in the PFC-sigma at two weeks, and at two years 42% and 9% respectively (p = 0.001).
conclusionIn the first two postoperative years the initial version of the ATTUNE tibial component was not inferior with respect to overall migration, although it showed relatively more backwards tilting and radiolucent lines at the implant-cement interface than the PFC-sigma. The version of the ATTUNE tibial component examined in this study has subsequently undergone modification by the manufacturer. Level of Evidence: 1 (randomized controlled clinical trial) Cite this article:
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