Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287021
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-02-09
Brief Title:
Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty
Sponsor:
Permedica spa
Organization:
Permedica spa
Study Overview
Official Title:
Bone Remodeling Around a 3D-printed Highly-porous Trabecular Titanium Acetabular Cup in Primary Total Hip Arthroplasty
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hydroxyapatitetitanium 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 hydroxyapatitetitanium 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 11 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
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 hydroxyapatitetitanium 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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None