NCT01183260|CompletedResultsDMC
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Sponsor study identifier
Secondary identifiers
OTHER · CCF IRB
interventional
25
1 country
1
Study Start
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2016
Actual (reported)Study Completion
January 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
August 13, 2010
Actual (reported)August 17, 2010
Actual (reported)August 2016
Actual (reported)January 2017
Actual (reported)November 7, 2017
Actual (reported)Periprosthetic Bone Mineral Density (BMD) of Hip
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. Region 1 forms the superior-lateral region, Region 2 forms the superior-medial region, and Region 3 forms the inferior-medial region around the acetabular component. For each region, the mean change in BMD was calculated using the following equation described by Wilkinson et al (J Bone Joint Surg Br., 2001): mean percent change in BMD = (BMD1-BMD2) x 2 x 100 / (BMD1 + BMD2). These regions were patient specific and remained the same each time the patient was scanned.
2 years postoperative; measured at 3 months (baseline), 6 months, 1 year, 2 year postoperative
Functional and General Health Outcome Assessments
2 years postoperative; measured preoperatively and 3 months, 6 months, 1 year, 2 year postoperative
Patients randomized to this arm will receive a trabecular metal revision component which does not have a titanium inner surface and requires a cemented highly crosslinked polyethylene liner.
Patients randomized to this arm will receive a trabecular metal modular component which has a titanium inner surface and requires a non-cemented highly crosslinked polyethylene liner.
Revision of the acetabular cup
Revision of the acetabular cup
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The Cleveland Clinic
Cleveland, Ohio, 44195, United States
A large amount of variability was present in the data leading to reduced statistical power during hypothesis testing
Wael K Barsoum, MD
The Cleveland Clinic
25 participants (actual enrollment reported by the registry).
First Submitted
August 13, 2010
First Posted
August 17, 2010
Study Start
August 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
August 2016
Actual (reported)Study Completion
January 2017
Actual (reported)Last Updated
November 7, 2017
Results First Posted
November 7, 2017
Record last verified: 2017-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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