Bone Remodeling Around a 3D-printed Highly-porous Trabecular Titanium Acetabular Cup in Primary Total Hip Arthroplasty
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: t
View:
• 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;
Locations
Other Locations
Italy
IRCCS Istituto Clinico San Siro
RECRUITING
Milan
IRCCS Ospedale Galeazzi-Sant'Ambrogio
RECRUITING
Milan
Contact Information
Primary
Lorenzo Banci, MSc
lorenzo.banci@permedica.it
+390399514811
Backup
Marta Colombo, MSc
marta.colombo@permedica.it
Time Frame
Start Date: 2024-04-09
Estimated Completion Date: 2028-06
Participants
Target number of participants: 50
Treatments
Experimental: Jump System Traser® cup
25 patients receiving unilateral primary total hip arthroplasty with the Jump System Traser® acetabular cup, a 3D-printed highly-porous titanium cup
Active_comparator: Jump System HAX-Pore® cup
25 patients receiving unilateral primary total hip arthroplasty with the Jump System HAX-Pore® acetabular cup, a standard hydroxyapatite/titanium plasma-sprayed cup
Related Therapeutic Areas
Sponsors
Leads: Permedica spa