Evaluation of the Trabecular Metal™ Revision Hip Cup Using Bone Mineral Density (DEXA)
|ClinicalTrials.gov Identifier: NCT01183260|
Recruitment Status : Completed
First Posted : August 17, 2010
Results First Posted : November 7, 2017
Last Update Posted : November 7, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Revision, Joint||Device: Trabecular Metal Revision Cup Device: Trabecular Metal Modular Cup||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Evaluation of the Trabecular Metal™ Acetabular Revision Cup Using Dual-Energy X-ray Absorptiometry (DEXA)|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||January 2017|
Experimental: Trabecular Metal Revision Cup
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.
Device: Trabecular Metal Revision Cup
Revision of the acetabular cup
Active Comparator: Trabecular Metal Modular Cup
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.
Device: Trabecular Metal Modular Cup
Revision of the acetabular cup
- Periprosthetic Bone Mineral Density (BMD) of Hip [ Time Frame: 2 years postoperative; measured at 3 months (baseline), 6 months, 1 year, 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. 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.
- 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 Hip disability and Osteoarthritis Outcomes Score (HOOS) and 12-item Short Form Health Survey (SF-12v2). All subscale scores are calculated independently and range from 0 to 100, where 100 indicates no problems:
- SF-12 Physical Component Summary Subscale (SF12 PCS) assesses physical function, bodily pain, and general health.
- SF-12 Mental Component Summary Subscale (SF12 MCS) assesses emotional and mental health.
- HOOS Pain assesses pain in the hip
- HOOS Symptoms assesses symptoms such as stiffness in the hip
- HOOS activities of daily living (HOOS ADL) assesses physical function while performing common daily activities (walking, sitting, standing, etc.)
- HOOS sport and recreation (HOOS Sports/Rec) assesses physical function while performing higher-level activities (running, squatting, etc.)
- HOOS hip-related quality of life (HOOS QOL) assesses how much the hip impacts life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01183260
|United States, Ohio|
|The Cleveland Clinic|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Wael K Barsoum, MD||The Cleveland Clinic|