Evaluation of the Trabecular Metal™ Revision Hip Cup Using Bone Mineral Density (DEXA)
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.
|Revision, Joint||Device: Zimmer Trabecular Metal Revision Cup Device: Zimmer Modular Cup||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Evaluation of the Trabecular Metal™ Acetabular Revision Cup Using Dual-Energy X-ray Absorptiometry (DEXA)|
- Periprosthetic Bone Mineral Density (BMD) of Hip [ Time Frame: 2 years postoperative; measured at 4 weeks (baseline), 3 months, 6 months, 1year, 2 year postoperative ]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.
- Functional and General Health Outcome Assessments [ Time Frame: 2 years postoperative; measured preoperatively and 3 months, 6 months, 1 year, 2 year postoperative ]Analyze and compare functional and general health outcomes of these patients, based on HOOS and SF-12v2.
|Study Start Date:||August 2010|
|Study Completion Date:||January 2017|
|Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
|Experimental: Zimmer Trabecular Metal Acetabular Cup||
Device: Zimmer Trabecular Metal Revision Cup
Revision of the acetabular cup
|Active Comparator: Zimmer Modular Cup||
Device: Zimmer Modular Cup
Revision of the acetabular cup
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183260
|United States, Ohio|
|The Cleveland Clinic|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Wael K Barsoum, MD||The Cleveland Clinic|