NCT06287021

Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty

Bone Remodeling Around a 3D-printed Highly-porous Trabecular Titanium Acetabular Cup in Primary Total Hip Arthroplasty

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Permedica spa · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed description

In joint arthroplasty, the need to use devices with highly-porous structures even more close to cancellous bone, arises from the need of optimal implant primary stability and osseointegration to guarantee long term longevity of the prosthetic implant. After decades of clinical use of highly-porous tantalum (Trabecular Metal) acetabular components in total hip arthroplasty with excellent results, new highly-porous titanium structures have been developed and introduced in the market thanks to the additive manufacturing technology. This study aims to investigate how bone remodeling occurs after primary total hip arthroplasty around a highly-porous trabecular-irregular acetabular cup, 3D-printed with selective laser melting, in comparison with a standard hydroxyapatite/titanium plasma-sprayed cup with the same design. The null hypothesis, which the study aims to reject, is that there is no difference in bone mineral density changes between highly-porous and traditional plasma-sprayed cups. Overall 50 patients will be enrolled to be 1:1 randomized for receiving the investigational cup or the control cup in two centers. Periprosthetic bone mineral density will be measured by DEXA (Dual-Energy X-ray Absorptiometry) around the acetabular cup according to four ROI (Region Of Interest). DEXA scans will be taken at different time-points up to 2-year follow-up. DEXA scan taken before patient discharge will be used as baseline. Patients will be assessed also for clinical and radiological results, with focus on osseointegration signs of the acetabular cup.

Conditions

• Total Hip Arthroplasty

Interventions

Type	Name	Description
DEVICE	Jump System Traser® cup	Press-fit, cementless, 3D-printed, highly-porous trabecular titanium acetabular cup
DEVICE	Jump System HAX-Pore® cup	Press-fit, cementless, hydroxyapatite/titanium plasma-sprayed acetabular cup

Timeline

• Start date: 2024-04-09
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2024-02-29
• Last updated: 2025-09-02

Locations

2 sites across 1 country: Italy