Bone Remodeling Around a Trabecular Titanium Cup in Total Hip Arthroplasty

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Total Hip Arthroplasty

Clinical Trial Details

NCT number	NCT06287021
Study type	Interventional
Source	Permedica spa
Contact	Lorenzo Banci, MSc
Phone	+390399514811
Email	lorenzo.banci@permedica.it
Status	Not yet recruiting
Phase	N/A
Start date	April 2024
Completion date	February 2027

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT02818894` - Spinal Anesthesia in Total Hip Arthroplasty	Phase 4
Completed	`NCT02242201` - Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular	Phase 4
Completed	`NCT02414542` - Minima Clinical Study
Completed	`NCT01817010` - Strength and Function Following Total Hip Arthroplasty	N/A
Completed	`NCT01443975` - Clinical Evaluation on the Use of the X-pander Device	N/A
Recruiting	`NCT05530174` - Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With a Fracture	N/A
Recruiting	`NCT05530551` - Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With OA	N/A
Recruiting	`NCT05054192` - Reliability and Validity of Modified Four Square Step Test
Recruiting	`NCT06141928` - Comparison of Three Different Surgical Approaches on the Functional Outcome After Total Hip Arthroplasty	N/A
Recruiting	`NCT04492462` - The Impact of Two Different Physical Therapy Programs in the Rehabilitation of Patients Undergoing Anterior Approach Hip Replacement Surgery	N/A
Withdrawn	`NCT02926651` - Single Versus Multi-Dose Oral Tranexamic Acid in Patients at High Risk for Blood Transfusion After Total Joint Arthroplasty	Phase 4
Completed	`NCT02308813` - Predictability of the Ability to Perform an Emergency Stop With Disorders of the Hip	N/A
Recruiting	`NCT02032017` - Percutaneous Assisted Approach for Total Hip Replacement and it's Effect on Functional Rehabilitation.	N/A
Recruiting	`NCT01312077` - The Analgesic Efficacy of Periarticular Infiltration of Local Anaesthetic for Total Hip Replacement	Phase 4
Withdrawn	`NCT01380665` - Prevena™ Incision Management System Over Primarily Closed Hip and Knee Incisions in Patients Immediately Post Total Hip and Knee Arthroplasty	Phase 4
Recruiting	`NCT05893563` - Corail Stability at 5-Years Post-Total Hip Arthroplasty
Recruiting	`NCT06088069` - Effect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty	N/A
Active, not recruiting	`NCT03210844` - The Clinical Outcomes After Direct Anterior Approach and Microposterior Approach for Total Hip Arthroplasty	N/A
Recruiting	`NCT04801680` - Mpact 3D Metal Cup PMS
Terminated	`NCT02006251` - Real-Time Instrument for Acetabular Shell Positioning