Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty
Bone Remodeling Around a 3D-printed Highly-porous Trabecular Titanium Acetabular Cup in Primary Total Hip Arthroplasty
Permedica spa
50 participants
Apr 9, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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 Criteria15
- 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;
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Interventions
Press-fit, cementless, 3D-printed, highly-porous trabecular titanium acetabular cup
Press-fit, cementless, hydroxyapatite/titanium plasma-sprayed acetabular cup
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06287021