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Nexus Evaluation Primary Trident II UNcemented shEll (NEPTUNE).

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Summary
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This study evaluates the survival and outcomes of a new uncemented hydroxyapatite (HA) coated acetabular component in hybrid total hip arthroplasty (THA). Results will inform the adoption of this novel implant in orthopedic practice.

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Area of Science:

  • Orthopedic Surgery
  • Biomaterials Science
  • Implant Technology

Background:

  • Hybrid total hip arthroplasty (THA) combines cemented and uncemented components.
  • Assessing the long-term performance of novel acetabular components is crucial for patient outcomes.
  • Hydroxyapatite (HA) coating aims to improve bone integration and implant survival.

Purpose of the Study:

  • To evaluate the survival rate of the uncemented HA-coated Trident II acetabular component in hybrid THA.
  • To assess complications, functional outcomes, quality of life, and radiological signs of loosening.
  • To provide data for the stepwise introduction of this new implant into clinical practice.

Main Methods:

  • A single-centre, prospective cohort study involving 125 hybrid THA implants.
  • Inclusion criteria focus on patients suitable for uncemented acetabular components within specific age and health parameters.
  • Exclusion criteria address inadequate bone stock, high BMI, and specific THA indications.

Main Results:

  • Implant survival, complications, functional outcomes, and radiological assessments will be monitored up to ten years post-THA.
  • Functional outcomes include Oxford Hip Score, Forgotten Joint Score, SF-12, EQ-5D, pain, and patient satisfaction.
  • Radiological assessment will identify lucent lines, lysis, and loosening using DeLee and Charnley zones.

Conclusions:

  • This study supports the Beyond Compliance principles for introducing new orthopedic devices.
  • The findings will offer crucial functional, radiological, and survival data on the HA-coated acetabular component.
  • Results will guide the decision for continued use or identify limitations of the new implant prior to widespread adoption.