Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty
Recruiting now · Not applicable
Conditions studied: Total Hip Arthroplasty
In brief
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.
Key facts
- Study ID
- NCT06287021
- Run by
- Permedica spa
- People needed
- 50
- Starts
- 2024-04-09
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2025-09-02
Who can join
Age: 40 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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 is running
- IRCCS Istituto Clinico San Siro — Milan, Italy (enrolling)
- IRCCS Ospedale Galeazzi-Sant'Ambrogio — Milan, Italy (enrolling)
Full record on ClinicalTrials.gov
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