Prospective Follow-up of the Prevision Hip Stem With Comparison of Different Implant Variants

Condition(s) studied

Investigational drug(s) / intervention(s)

Prevision Revision hip endoprosthesis stem implantation: The Prevision hip endoprosthetic stem is a femoral part of a hip joint endoprosthesis. The system provides cementless and cemented variants. Prevision hip stems are modular with a short proximal and longer distal component, or monobloc hip stems. Modular components are coupled via a Prevision specific conical connection with a torque wrench and a tension nut to apply a predefined torsional moment on the connection. The distal component of modular Prevision stems can be combined with locking screws for additional bone fixation. Both types, the monobloc and the modular, provide a 12/14 taper that serves as a connection for metal or ceramic prosthesis heads. Prevision hip stems are combined at the acetabulum with a cementless or cemented acetabular cup.

Study summary

The study design is confirmative for non-inferiority of the functional outcome of the implants and is intended to examine the safety and performance of the Prevision hip stem. The study is an observational post-market clinical follow-up study, and the study sites chose the stem variant depending on their own routine and indication.

Eligibility

Primary outcome measure(s)

• Functional outcome of the hip revision surgery — after two years
  Oxford Hip Score:The Oxford Hip Score (OHS) is a joint-specific, patient-reported outcome measure designed to assess disability in patients undergoing total hip replacement (THR)

Trial sites (2)

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