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NCT01183260 · ClinicalTrials.gov registry record · NA
Evaluation of the Trabecular Metal™ Revision Hip Cup Using Bone Mineral Density (DEXA)
A NA study, sponsored by The Cleveland Clinic.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT01183260 is a NA study that has completed, run by The Cleveland Clinic. The registered enrollment target is 25 participants.
The verdict
NCT01183260, a NA study, has completed, sponsored by The Cleveland Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Trabecular Metal Revision Cup
- DEVICE Trabecular Metal Modular Cup
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2010-08 |
| Est. Completion | 2017-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01183260
The ClinicalTrials.gov registry entry for NCT01183260 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Trabecular Metal Revision Cup is the first listed.
NCT01183260 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01183260 about?
NCT01183260 is a clinical study titled "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. ...
What is the current status of trial NCT01183260?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2010-08. Estimated completion is 2017-01.
What interventions are being tested in trial NCT01183260?
The interventions under investigation include: Trabecular Metal Revision Cup (DEVICE), Trabecular Metal Modular Cup (DEVICE).
Who is sponsoring clinical trial NCT01183260?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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