Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty (NCT06287021) | Clinical Trial Compass
RecruitingNot Applicable
Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty
Italy50 participantsStarted 2024-04-09
Plain-language 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.
Who can participate
Age range40 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
What they're measuring
1
BMD - ROI 1
Timeframe: Preoperative, 1 week postoperatively, 3-month, 6-month,12-month, and 24-month follow-up