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

Bone Remodeling Around a 3D-printed Highly-porous Trabecular Titanium Acetabular Cup in Primary Total Hip Arthroplasty

This study is testing whether a new 3D-printed hip implant helps improve bone strength better than a standard hip implant in patients getting hip replacement surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 40 Years to 85 Years
• Sex: All
• Sponsor: Permedica spa (Industry-sponsored)
• Locations: 2 sites (Milan and 1 other locations)
• Trial ID: NCT06287021 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40-85 undergoing unilateral cementless primary total hip arthroplasty due to primary or secondary hip osteoarthritis.

Not a fit: Patients with specific bone disorders or those outside the age criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved long-term outcomes and stability for patients receiving total hip arthroplasty.

How similar studies have performed: While the use of highly-porous tantalum components has shown success, this specific approach with 3D-printed titanium structures is relatively novel and untested.

Eligibility criteria

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 this trial is running

Milan and 1 other locations

• 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

Conditions Total Hip Arthroplasty; Bone Mineral Density; DEXA; Additive Manufacturing; 3D-Printing; Selective Laser Melting; Highly-Porous Titanium