Investigating bone changes around a new 3D-printed hip implant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the changes in bone mineral density around a highly-porous 3D-printed titanium acetabular cup versus a standard hydroxyapatite/titanium plasma-sprayed cup in patients undergoing total hip arthroplasty. A total of 50 patients will be randomly assigned to receive either the investigational or control cup, with bone density measured using DEXA scans at various time points over a two-year follow-up period. The study seeks to determine if the new implant design offers superior osseointegration and stability compared to traditional methods.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient candidated to undergo unilateral cementless primary total hip arthroplasty with Jump System Traser® cup or Jump System HAX-Pore® cup by Permedica Orthopaedics (study sponsor).
* Patient with primary or secondary hip osteoarthritis;
* Patient who has given informed consent;

Exclusion Criteria:

* Male patients younger than 40 years or older than 85 years;
* Female patients younger than 50 years or older than 85 years;
* Childbearing;
* Patients not indicated for receiving the investigational devices;
* Patients not indicated for receiving cementless metaphyseal short femoral stems by Permedica Orthopaedics as the "Exacta RS" or "Exacta S" brand;
* Patients with rheumatoid arthritis, avascular osteonecrosis, severe hip dysplasia (grade III-IV according to Crowe classification), Perthes disease, Paget disease, femoral neck fracture, pelvic fracture or sequelae of previous surgical procedures or trauma to the ipsilateral hip;
* Patients with bone disorders;
* Patients with diabetes;
* Patients under PTH (parathyroid hormone), corticosteroid, or osteoporosis pharmacological therapy;
* Patients with disabling disease in the contralateral limb;
* Patients with BMI \> 30 or \< 18;
* Patients not willing to follow the study protocol;
* Patients incapable to understand the study protocol;
* Patients addicted to alcohol or drugs;
* Patients already enrolled in other clinical investigations;

Where it's running

• IRCCS Istituto Clinico San Siro
  Milan, Italy Recruiting
• IRCCS Ospedale Galeazzi-Sant'Ambrogio
  Milan, Italy Recruiting

Study contacts

• Principal investigator: Giuseppe Peretti, MD — IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan, Italy
• Study coordinator: Lorenzo Banci, MSc
• Email: lorenzo.banci@permedica.it
• Phone: +390399514811

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.