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| ID | Type | Description | Link |
|---|---|---|---|
| 09-859 | Other Identifier | CCF IRB |
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| Name | Class |
|---|---|
| Zimmer Biomet | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trabecular Metal Revision Cup | Experimental | 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. |
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| Trabecular Metal Modular Cup | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trabecular Metal Revision Cup | Device | Revision of the acetabular cup |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional and General Health Outcome Assessments | 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:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wael K Barsoum, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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Recruitment period: 2010 - 2014
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| ID | Title | Description |
|---|---|---|
| FG000 | Zimmer Trabecular Metal Acetabular Cup | Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup |
| FG001 | Zimmer Modular Cup | Zimmer Modular Cup: Revision of the acetabular cup |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Zimmer Trabecular Metal Acetabular Cup | Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup |
| BG001 | Zimmer Modular Cup | Zimmer Modular Cup: Revision of the acetabular cup |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | By Year 2, there were 3 patients lost to follow-up in the Revision Cup group and 3 patients lost to follow-up in the Modular Cup group: We were unable to contact 1 patient from each group in order to schedule follow-up The remaining patients were withdrawn because they were feeling fine and declined to return for follow-up at that time | Posted | Mean | Standard Deviation | g/cm^2 | 2 years postoperative; measured at 3 months (baseline), 6 months, 1 year, 2 year postoperative |
2 Years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zimmer Trabecular Metal Acetabular Cup | Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Revision surgery due to multiple dislocations | Surgical and medical procedures | Systematic Assessment |
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A large amount of variability was present in the data leading to reduced statistical power during hypothesis testing
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Klika, Research Program Manager | Cleveland Clinic | 216-444-4954 | klikaa@ccf.org |
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| Trabecular Metal Modular Cup |
| Device |
Revision of the acetabular cup |
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| 2 years postoperative; measured preoperatively and 3 months, 6 months, 1 year, 2 year postoperative |
| Revised within 30 days |
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| Death |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Operative Side: Left, Right | Count of Participants | Participants |
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| BMI (kg/m^2), Continuous | Mean | Standard Deviation | kg/m^2 |
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| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Zimmer Trabecular Metal Acetabular Cup | Zimmer Trabecular Metal Revision Cup: Revision of the acetabular cup |
| OG001 | Zimmer Modular Cup | Zimmer Modular Cup: Revision of the acetabular cup |
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| Secondary | Functional and General Health Outcome Assessments | 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:
| By Year 2, there were 3 patients lost to follow-up in the Revision Cup group and 3 patients lost to follow-up in the Modular Cup group: We were unable to contact 1 patient from each group in order to schedule follow-up | Posted | Mean | Standard Deviation | units on a scale | 2 years postoperative; measured preoperatively and 3 months, 6 months, 1 year, 2 year postoperative |
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| 1 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Zimmer Modular Cup | Zimmer Modular Cup: Revision of the acetabular cup | 0 | 11 | 1 | 11 | 0 | 11 |
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| Preop SF12 MCS |
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| 3 Month SF12 PCS |
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| 3 Month SF12 MCS |
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| 6 Month SF12 PCS |
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| 1 Year SF12 PCS |
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| 2 Year SF12 PCS |
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| 2 Year SF12 MCS |
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| Preop HOOS Pain |
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| Preop HOOS Sports/Rec |
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| 3 Month HOOS Pain |
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| 6 Month HOOS Pain |
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| 6 Month HOOS ADL |
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| 1 Year HOOS Pain |
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| 1 Year HOOS Symptoms |
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| 1 Year HOOS ADL |
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| 1 Year HOOS Sports/Rec |
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| 1 Year HOOS QOL |
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| 2 Year HOOS Pain |
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| 2 Year HOOS Symptoms |
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| 2 Year HOOS ADL |
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| 2 Year HOOS Sports/Rec |
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| 2 Year HOOS QOL |
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