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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

Winther, Nikolaj S.; Jensen, Claus L.; Jensen, Claus M.; Lind, Thomas; Schrøder, Henrik M.; Flivik, Gunnar LU and Petersen, Michael M. (2016) In Knee 23(6). p.1002-1011
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... (More)

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.

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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Radiostereometric study, Randomized clinical trial, Regenerex, Total knee arthroplasty, Trabecular metal
in
Knee
volume
23
issue
6
pages
10 pages
publisher
Elsevier
external identifiers
  • scopus:85003845919
  • wos:000390742000014
ISSN
0968-0160
DOI
10.1016/j.knee.2016.09.010
language
English
LU publication?
yes
id
30baeeba-7b1a-43df-88dc-45af05f1a832
date added to LUP
2016-12-28 15:47:18
date last changed
2017-09-18 11:33:54
@article{30baeeba-7b1a-43df-88dc-45af05f1a832,
  abstract     = {<p>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.</p>},
  author       = {Winther, Nikolaj S. and Jensen, Claus L. and Jensen, Claus M. and Lind, Thomas and Schrøder, Henrik M. and Flivik, Gunnar and Petersen, Michael M.},
  issn         = {0968-0160},
  keyword      = {Radiostereometric study,Randomized clinical trial,Regenerex,Total knee arthroplasty,Trabecular metal},
  language     = {eng},
  month        = {12},
  number       = {6},
  pages        = {1002--1011},
  publisher    = {Elsevier},
  series       = {Knee},
  title        = {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},
  url          = {http://dx.doi.org/10.1016/j.knee.2016.09.010},
  volume       = {23},
  year         = {2016},
}