CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 25 enrolled
Drug / intervention
Trabecular Metal Revision Cup +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01183260
NCT01183260N/ACompleted

Evaluation of the Trabecular Metal™ Acetabular Revision Cup Using Dual-Energy X-ray Absorptiometry (DEXA)

The Cleveland Clinic·interventional·Posted Aug 17, 2010·Updated Nov 7, 2017

In Brief

A clinical study evaluating Trabecular Metal Revision Cup and Trabecular Metal Modular Cup for Revision, Joint. Completed, enrolled 25 participants across 1 site.

Detailed Summary

In 1997, the FDA approved the use of Trabecular Metal™ (Zimmer, Trabecular Metal Technology, Inc., Parsippany, NJ) for acetabular cups, a porous tantalum structural biomaterial that was developed to address the limitations of other implant materials, with the potential to improve implant fixation. Porous tantalum (80% porosity) offers potentially greater ingrowth and bone graft incorporation, believed to be restricted by the low porosity of other commonly used implants (30%). Additionally, the low modulus of elasticity property (3 MPa) of porous tantalum provides more normal physiological loading conditions which theoretically reduce stress shielding and resultant bone loss surrounding the implant. These properties are much desired advantages for implants used in cementless THA. Various porous tantalum implants have shown favorable clinical results. Unger et al. reported excellent bone graft incorporation of the acetabular component based on serial radiograph data at a minimum 1-year follow-up. Dual-energy X-ray absorptiometry (DEXA) is a well-established method for detecting periprosthetic bone mass changes around the femoral and acetabular THA components. The primary objective of this study is to quantify and compare periprosthetic bone mineral density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed acetabular components, measured using DEXA scanning techniques. Additionally, this study will analyze and compare clinical outcomes of these patients, based on SF-12v2 and HOOS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRevision, Joint
CountriesUnited States
CollaboratorsZimmer Biomet

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 17, 2010
Enrollment StartAug 1, 2010
Primary CompletionAug 1, 2016
Study CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 15.9 years ago

Interventions

Trabecular Metal Revision Cupdevice

Revision of the acetabular cup

Trabecular Metal Modular Cupdevice

Revision of the acetabular cup