Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty

Launched by PERMEDICA SPA · Feb 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how the bone around a special type of hip implant, called a 3D-printed titanium acetabular cup, changes over time after hip replacement surgery. The researchers want to compare the bone health around this new implant to a standard implant that has a coating made of hydroxyapatite and titanium. They will track the participants for up to two years to see which implant helps keep the bone stronger.

To be eligible for this study, participants should be adults aged 40 to 85 who need a hip replacement due to osteoarthritis. They must be able to give their consent and not have certain health conditions that could complicate the surgery or the study. If you join the trial, you can expect regular check-ups and tests to monitor your bone health after receiving one of the implants. This study is currently recruiting participants, and your involvement could help improve hip surgery outcomes for future patients.

Gender

ALL

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;