NCT06287021 Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty
| NCT ID | NCT06287021 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Permedica spa |
| Condition | Total Hip Arthroplasty |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-04-09 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-04-09 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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;
Contact & Investigator
Lorenzo Banci, MSc
STUDY DIRECTOR
Permedica Orthopaedics, Merate, Italy
Frequently Asked Questions
Who can join the NCT06287021 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 85 Years, studying Total Hip Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06287021 currently recruiting?
Yes, NCT06287021 is actively recruiting participants. Contact the research team at lorenzo.banci@permedica.it for enrollment information.
Where is the NCT06287021 trial being conducted?
This trial is being conducted at Milan, Italy, Milan, Italy.
Who is sponsoring the NCT06287021 clinical trial?
NCT06287021 is sponsored by Permedica spa. The principal investigator is Lorenzo Banci, MSc at Permedica Orthopaedics, Merate, Italy. The trial plans to enroll 50 participants.