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| ID | Type | Description | Link |
|---|---|---|---|
| 06-300, Revised 3-1-2010 | Other Identifier | Zimmer - revision date |
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Sponsor business decision unrelated to clinical performance.
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This is a post-approval study with prospective enrollment in the United States and a retrospective enrollment outside the United States to obtain functional, quality of life and radiographic data, which will facilitate assessment of the clinical performance of the Zimmer Trilogy AB Acetabular Hip System.
To obtain functional, quality of life and radiographic data to evaluate the clinical performance of the Zimmer Trilogy AB Acetabular Hip System in primary total hip replacement surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trilogy AB Acetabular Hip Implant System | Other | Post Approval Study of Device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trilogy AB Acetabular Hip Implant System | Device | Total hip replacement with ceramic on ceramic treatment surfaces. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score | The Harris Hip Score was developed to assess hip disabilities and methods of treatment and has been in use for decades. It evaluates patients on the basis of pain, function, absence of deformity and range of motion. The Harris Hip Score could range from 0 to 100. Scores less then 70 are poor, scores 70 to 79 are fair, scores 80 to 89 are good, and scores 90 to 100 are excellent. | Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Continued Assessment of Implant Survivorship and Incidences of Adverse Events. | A total of 37 Adverse Events were reported. There have been no UADEs reported in this study population. At the time of site closure all AEs were resolved or tolerated. Implant survivorship not reportable due to early study termination. | At all follow-up visits through 5 Years and postcard follow-up 6 - 10 Years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Schrock, MD | Schrock Orthopedic Research | Principal Investigator |
| Gwo-Chin Lee, MD | University of Pennsylvania/Penn Presbyterian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shrock Orthopedic Research | Fort Lauderdale | Florida | 33136 | United States | ||
| University of Pennsylvania |
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| ID | Title | Description |
|---|---|---|
| FG000 | Trilogy AB Acetabular Hip Implant System | Post Approval Study of Device. Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Trilogy AB Acetabular Hip Implant System | Post Approval Study of Device. Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Score | The Harris Hip Score was developed to assess hip disabilities and methods of treatment and has been in use for decades. It evaluates patients on the basis of pain, function, absence of deformity and range of motion. The Harris Hip Score could range from 0 to 100. Scores less then 70 are poor, scores 70 to 79 are fair, scores 80 to 89 are good, and scores 90 to 100 are excellent. | Data was received on 24 subjects/25 hips at preop, on 17 subjects/18 hips at 3 months, and on 4 subjects at 1 year prior to the early termination of the study. Each hip, whether unilateral or bilateral, was counted separately. Early study termination was done due to voluntary removal of the device from the US market. | Posted | Mean | Standard Deviation | units on a scale | Pre-op, 3 Month Post-Op and Annual Post-Op visits through 5 Years |
|
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Of the Serious Adverse Events, all were not related to the device. Of the other Adverse Events 3 were related to device and 2 were uncertain in relation.
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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 | Trilogy AB Acetabular Hip Implant System | Post Approval Study of Device. Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrhythmia | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash/Skin Lesions | Skin and subcutaneous tissue disorders | Systematic Assessment |
A business decision unrelated to device performance led to the early termination of the study and withdrawal of the study device(s) from the US market. Early termination of the study limits the usefulness of the available data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Affairs | Zimmer | 574-371-8019 | erin.osborn@zimmer.com |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010020 | Osteonecrosis |
| D006618 | Hip Dislocation, Congenital |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
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| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Surgery done on non-study consented hip |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Post Approval Study of Device.
Trilogy AB Acetabular Hip Implant System : Total hip replacement with ceramic on ceramic treatment surfaces.
|
|
| Secondary | Continued Assessment of Implant Survivorship and Incidences of Adverse Events. | A total of 37 Adverse Events were reported. There have been no UADEs reported in this study population. At the time of site closure all AEs were resolved or tolerated. Implant survivorship not reportable due to early study termination. | Posted | Number | adverse events | At all follow-up visits through 5 Years and postcard follow-up 6 - 10 Years |
|
|
|
| 6 |
| 25 |
| 14 |
| 25 |
| Other/General | General disorders | Systematic Assessment |
|
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Contralateral Hip Replacement | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| GI Bleed | Gastrointestinal disorders | Systematic Assessment |
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| Respiratory Failure/Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pre-Renal Azotemia | Renal and urinary disorders | Systematic Assessment |
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| Infection/Fever/Drainage | Infections and infestations | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Thigh/Hip/Groin Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Both instances of Thigh/Hip/Groin Pain were uncertain in the relation to the device. |
|
| Femur Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment | All 3 femur fractures were definitely related to the device |
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| Bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Oxygen Desaturation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Electrolyte Imbalance | General disorders | Systematic Assessment |
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| Alcohol Abuse/Withdrawal | General disorders | Systematic Assessment |
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| Hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000082602 | Developmental Dysplasia of the Hip |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Title | Measurements |
|---|---|
|
| AEs - Uncertain relation to device |
|