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The study is designed to evaluate artificial hips with a 28 mm ceramic head and a ceramic liner to determine whether they perform as well as artificial hips with a 28 mm ceramic head and a polyethylene liner.
Total Hip Arthroplasty (THA) is the surgical reconstruction of the hip joint through replacement of the femoral head and the acetabular articulating surfaces with fixed prosthetic devices. The goals of THA are relief from pain, restoration of function, and correction of deformity. THA is one of the most common adult reconstructive procedures. Over the past 25 years, patients who have needed to have their hip joint replaced, either due to trauma or arthritic disease, typically have had their hip joint bone articular surfaces replaced with a metal hip stem, metal ball head (either stainless steel or chrome cobalt) and a plastic acetabular cup (metal/metal/plastic). While the basic device has remained essentially unchanged over that period, technological advancements in implant designs and materials, and improvements in surgical technique and instrumentation have made THA one of the most durable and successful procedures in medicine. Reproducible, high-quality, short-term and mid-term results are attained regularly, and total hip replacements commonly last 10 to 15 years and longer. The success of this procedure has allowed its expansion into a wider, and often younger and more active population.
In spite of the improvements in THA, little change has occurred for the acetabular cup liner, which is usually made out of Ultra High Molecular Weight Polyethylene plastic (UHMWPe). Because it is plastic and inherently soft and somewhat pliable under load, the cup's articular surface must inevitability wear and produce debris. This biologic response is now thought to be a significant contributor to prosthetic component loosening, a primary failure mode of THR. UHMWPe also degrades with time in the body. As concerns about polyethylene wear and the associated untoward effects of the generated wear debris, and as THA continues to be used in younger and higher-demand patients with increasing life expectancies, interest in ceramic on ceramic total hip prosthesis has been renewed.
An alumina ceramic-on-ceramic acetabular coupling has been employed as an alternative to metal/polyethylene couplings. This ceramic-on-ceramic coupling has many advantages, including the elimination of polyethylene from the device system, wear rates that are appreciably less than those experienced with metal/polyethylene couplings and reduced biologic reactivity. The potential benefits of an alumina ceramic/ceramic bearing are significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delta Ceramax Ceramic-on-Ceramic Acetabular Cup System | Active Comparator | Total hip replacement with a 28 mm ceramic head and liner. |
|
| Pinnacle™ Acetabular Cup with Marathon® Polyethylene | Active Comparator | Total hip replacement with 28 mm ceramic head with a polyethylene liner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 28 mm ceramic head on ceramic acetabular liner. | Device | Total hip replacement with 28 mm ceramic head on ceramic liner articulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Total Score | The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. Scores ranges from a minimum of zero to a maximum score of 100. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored. | The Harris Hip Total Score evaluation took place at 6 weeks, 6 months, 12 months, and a final evaluation at 24 months or greater (up to 96 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rates | Complication Rates are reported by each type of complication (adverse events/AEs) in the Adverse Events Tab | The Complication Rates were evaluated at 6 weeks, 6 months, 12 months, and a final evaluation at 24 months or greater (up to 96 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joel Politi, MD | Cardinal Orthopaedic Institute | Principal Investigator |
| Douglas Dennis, MD | Colorado Joint Replacement | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Joint Replacement | Denver | Colorado | 80210 | United States | ||
| Cardinal Orthopaedic Institute |
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Patients were selected for recruitment into the study from the general diagnosis population defined as "primary total hip arthroplasty (THA) for non-inflammatory degenerative joint disease (NIDJD)." The investigation was conducted at 8 centers. Each center randomly assigned patients to both the investigational and control treatment groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System | The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis. |
| FG001 | Pinnacle™ Acetabular Cup With Marathon® Polyethylene | Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System | The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Harris Hip Total Score | The Harris Hip scoring system assigns a numeric value to responses from patients and assessments made by a surgeon. Scores ranges from a minimum of zero to a maximum score of 100. A score of 91-100 is excellent, 81-90 is good, 71-80 is fair, 70 or below is poor. The patient records the following: pain level, need for assistance when walking, presence of a limp, distance able to walk, ability to put on shoes and socks, climb stairs, use public transportation and the length of time one is able to comfortably sit in a chair are all scored. | Posted | Mean | Standard Deviation | Units on a scale | The Harris Hip Total Score evaluation took place at 6 weeks, 6 months, 12 months, and a final evaluation at 24 months or greater (up to 96 months) |
|
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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 | Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System | The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dave Whalen | DePuy Orthopaedics, Inc | 574-372-7028 | DWhalen@its.jnj.com |
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| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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|
| 28 mm ceramic head on polyethylene liner | Device | Total hip replacement with 28 mm ceramic head on a polyethylene liner articulation. |
|
|
| Columbus |
| Ohio |
| 43213 |
| United States |
| BG001 | Pinnacle™ Acetabular Cup With Marathon® Polyethylene | Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Pinnacle™ Acetabular Cup With Marathon® Polyethylene | Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis. |
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| Secondary | Complication Rates | Complication Rates are reported by each type of complication (adverse events/AEs) in the Adverse Events Tab | Complication Rates are contained in the Adverse Events Tab and include all reported complications in all patients as represented in the Final Clinical Study Report | Posted | Number | Complications | The Complication Rates were evaluated at 6 weeks, 6 months, 12 months, and a final evaluation at 24 months or greater (up to 96 months) |
|
|
|
| 4 |
| 177 |
| 27 |
| 177 |
| 80 |
| 177 |
| EG001 | Pinnacle™ Acetabular Cup With Marathon® Polyethylene | Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis. | 3 | 87 | 14 | 87 | 44 | 87 |
| Endocrine/Metabolic | Endocrine disorders | Non-systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dislocation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Neurological | Nervous system disorders | Non-systematic Assessment |
|
| Genitourinary | Renal and urinary disorders | Non-systematic Assessment |
|
| Respiratory | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Acetabular liner failure | Surgical and medical procedures | Non-systematic Assessment |
|
| Femoral Component Loosening | Surgical and medical procedures | Non-systematic Assessment |
|
| Wound Problem | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Genitourinary | Renal and urinary disorders | Non-systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.