Comparison of a novel porous titanium construct (Regenerex®) to a well proven porous coated tibial surface in cementless total knee arthroplasty — A prospective randomized RSA study with two-year follow-up

Research output: Contribution to journalArticle

Abstract

Background Regenerex is a novel porous titanium construct with a three-dimensional porous structure and biomechanical characteristics close to that of normal trabecular bone. The aim of this study was to compare this novel construct to a well-proven porous plasma sprayed tibial (PPS) implant after total knee arthroplasty. Methods Sixty-one patients scheduled for an uncemented TKA were randomized to receive either a novel highly porous titanium construct Regenerex or the PPS tibial component. Radiostereometric analysis of the tibial components was performed postoperatively and at three, six, 12, and 24 months with measurements of migration (segment motion and maximum total point motion (MTPM)). Results Knee and function scores improved significantly from preoperatively to two-year follow-up. For both the Regenerex and the PPS the majority of migration appeared during the first three months and then stabilized. No statistically significant differences in MTPM were found in any follow-up between three and 24 months. The Regenerex group had a lower migration rate between 12 and 24 months compared with the PPS implants (p = 0.03) but the PPS group had an initial significantly lower subsidence (p = 0.04). Conclusion In conclusion the Regenerex implant could prove an effective scaffold material for coating of uncemented implants but did no better than the PPS component at 24 months of follow-up. ClinicalTrials.gov identifier: NCT01936415.

Details

Authors
  • Nikolaj S. Winther
  • Claus L. Jensen
  • Claus M. Jensen
  • Thomas Lind
  • Henrik M. Schrøder
  • Gunnar Flivik
  • Michael M. Petersen
Organisations
External organisations
  • Copenhagen University Hospital
  • Gentofte Hospital
  • Skåne University Hospital
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Orthopedics

Keywords

  • Radiostereometric study, Randomized clinical trial, Regenerex, Total knee arthroplasty, Trabecular metal
Original languageEnglish
Pages (from-to)1002-1011
Number of pages10
JournalKnee
Volume23
Issue number6
Publication statusPublished - 2016 Dec 1
Publication categoryResearch
Peer-reviewedYes