Actively Recruiting

Phase Not Applicable
Age: 40Years - 85Years
All Genders
Healthy Volunteers
NCT06287021

Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty

Led by Permedica spa · Updated on 2025-09-02

50

Participants Needed

2

Research Sites

216 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this randomized controlled trial is to measure the periprosthetic bone mineral density changes around a 3D-printed highly-porous titanium acetabular cup used in primary total hip arthroplasty compared to a standard hydroxyapatite/titanium plasma-sprayed acetabular cup up to 2-year follow-up.

CONDITIONS

Official Title

Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty

Who Can Participate

Age: 40Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient scheduled for unilateral cementless primary total hip arthroplasty with Jump System Traser�ae or Jump System HAX-Pore�ae cup
  • Patient diagnosed with primary or secondary hip osteoarthritis
  • Patient has given informed consent
Not Eligible

You will not qualify if you...

  • Male patients younger than 40 years or older than 85 years
  • Female patients younger than 50 years or older than 85 years
  • Pregnant or childbearing patients
  • Patients not suitable for the investigational devices
  • Patients not suitable for cementless metaphyseal short femoral stems by Permedica Orthopaedics (Exacta RS or Exacta S)
  • Patients with rheumatoid arthritis, avascular osteonecrosis, severe hip dysplasia (Crowe grade III-IV), Perthes disease, Paget disease, femoral neck fracture, pelvic fracture, or prior hip surgery/trauma sequelae
  • Patients with bone disorders
  • Patients with diabetes
  • Patients on parathyroid hormone, corticosteroid, or osteoporosis treatments
  • Patients with disabling disease in the opposite limb
  • Patients with body mass index over 30 or under 18
  • Patients unwilling or unable to follow or understand the study protocol
  • Patients addicted to alcohol or drugs
  • Patients already enrolled in other clinical studies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

IRCCS Istituto Clinico San Siro

Milan, Italy, 20148

Actively Recruiting

2

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Italy, 20161

Actively Recruiting

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Research Team

L

Lorenzo Banci, MSc

CONTACT

M

Marta Colombo, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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