Clinical data

The clinical performance and effects of X-pander are very well documented in published peer-reviewed literature. Here you will get an overview.

 

Dynamic trial fitting of the cup in press-fit total hip arthroplasty, a feasibility study ; Acta Orthopaedica Belgica, Vol. 87 - 2 - 2021, D. Hoornenborg et al. A structured surgeon survey of 78 primary and 31 revision THR procedures. 45 surgeons from 7 European countries participated. Key findings:

 

  • In 33% of cases X-pander caused intra-operative decision change to either refine reaming and/or adjust the cup size
  • In 87% of cases did the surgeon evaluate that X-pander gives more useful information than traditional trial cups
  • In 61% of cases the surgeon felt more confident in achieving good primary stability because of X-pander
  • In 50% of cases surgeons answered that X-pander led to better cup-insertion compared to using traditional trial cups. There were no reports that it was worse
  • In 22% of cases surgeons said X-pander is time saving
  • In 37% of primary cases surgeons evaluated that X-pander can lead to less use of screws
  • Dynamic trialing with X-pander can replace traditional trial cups

Dynamic trial fitting by an expanding trial cup does not jeopardize primary acetabular component stability ; Clinical Biomechanics, Vol. 78, 2020, D. Hoornenborg et al. A biomechanical study using bovine calf cadaver acetabula revealed:

 

  • Using X-pander for dynamic trialing, and thereby pre-expanding, the acetabulum does not change mechanical properties of the acetabular bone
  • Optimal primary stability of the final cup is not compromised
  • X-pander is safe to use in clinical practice
  • Risk of intra-operative acetabular rim fractures is expected to decrease when using X-pander

Dynamic trial fitting of the cup, is the simulated press-fit reliable?; Poster presentation at the 13th Congress of the European Hip Society, September 2018, D. Hoornenborg et al.

 

  • Lever-out force of X-pander correlates well with lever-out force of final cup
  • X-pander gives tactile information about primary cup stability
  • Trial cups do not resemble the real press-fit obtained by the definitive cup

 

Other Clinical Experience

Non-documented frequent feedback from surgeons include:

 

  • Eliminates cup waste: When using X-pander the first choice of cup-size is always the right and there is never a cup wasted
  • Accelerates learning curve: Teaching institutions praise X-pander for enabling junior surgeons master the cup insertion significantly faster
  • Takes guesswork out of bone quality adjusted sizing: Hard sclerotic bone cannot adapt to the same cup oversize as soft osteoporotic bone. X-pander reliably guides to the optimal patient specific implant size
  • Validates the reamed acetabular geometry: A blunt vs. a sharp reamer does not ream the same size – and a drifting reamer does not create a hemispherical cavity. X-pander reveals inadequacies in a matter of seconds intra-operatively
  • Makes trial cups obsolete: Traditional trial cups can be completely removed from the surgical instrumentation set, thus saving sterilization costs, heavy lifting and space in the OR
  • Decreases use of screws: As X-pander validates primary cup stability it also gives confidence to not use superfluous screw fixation