Not provided
Not provided
Not provided
Not provided
Not provided
Lack of enrollment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to review the performance and success rate of an FDA cleared cementless hip replacement part called the Trident II Tritanium Acetabular Shell. The study will specifically look at the need to revise the hip replacement after 5 years. This will be compared to how much this happens in patients who have hip replacement with similar cementless acetabular shells.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trident II Tritanium Acetabular Shell for Revision | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trident II Tritanium Acetabular Shell for Revision | Device | A hemispherical acetabular shell indicated for cementless application in a previously failed total hip arthroplasty (THA) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cases Free From Trident II Acetabular Shell Revision | To demonstrate, through absence of revision for aseptic loosening at five years postoperative, that acetabular revision with the Trident II Acetabular Shell provides clinical results comparable to similar acetabular components for revision indications. The study was terminated prior to the 5-year timepoint, data is presented through 2-years postoperative. | 6 Weeks, 3-6 Months, 1 Year and 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Stability | Radiographic stability is a composite endpoint evaluating radiolucency and migration. Radiographic stability is defined as cases (hips implanted) which do not present with migration of greater than 5 mm in any direction or at least 2 mm radiolucency in all zones. | 6 Weeks and 3-6 Months |
Not provided
Inclusion Criteria:
A. Patient has signed an IRB approved, study specific Informed Patient Consent Form.
B. Patient is a male or non-pregnant female age 18-85 years of age at the time of study device implantation.
C. Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component.
D. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
Exclusion Criteria:
E. Patient has a Body Mass Index (BMI) > 45. F. Patient is diagnosed with Inflammatory Arthritis. G. Patient has a non-Stryker retained stem. H. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation.
I. Patient has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
J. Patient has compromised bone stock which cannot provide adequate support and/or fixation to the prosthesis.
K. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
L. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days). M. Patient has a known sensitivity to device materials. N. Patient is a prisoner.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lafayette General Orthopedic Center | Lafayette | Louisiana | 70506 | United States | ||
| Ochsner Clinic Foundation |
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Trident II Tritanium Acetabular Shell for Revision | Trident II Tritanium Acetabular Shell for Revision: A hemispherical acetabular shell indicated for cementless application in a previously failed total hip arthroplasty (THA) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
14 Participants, including one subject with bilateral hips implanted for a total of 15 Hips Implanted. All Demographic Data presented by Participant.
| ID | Title | Description |
|---|---|---|
| BG000 | Trident II Tritanium Acetabular Shell for Revision | Trident II Tritanium Acetabular Shell for Revision: A hemispherical acetabular shell indicated for cementless application in a previously failed total hip arthroplasty (THA) |
| 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 | Number of Cases Free From Trident II Acetabular Shell Revision | To demonstrate, through absence of revision for aseptic loosening at five years postoperative, that acetabular revision with the Trident II Acetabular Shell provides clinical results comparable to similar acetabular components for revision indications. The study was terminated prior to the 5-year timepoint, data is presented through 2-years postoperative. | One subject (1 Hip Implanted) did not return for a 6-Week Post-Operative Visit. Data are presented for 14 implanted for latest follow-up timepoint reached by each subject; presented at 6 Weeks (N=14 Hips Implanted), 3-6 Months (N=11 Hips Implanted), 1 Year (N=8 Hips Implanted) and 2 Years (N=2 Hips Implanted). | Posted | Count of Units | Hips Implanted | 6 Weeks, 3-6 Months, 1 Year and 2 Years | Hips Implanted | Hips Implanted |
|
Adverse event data was collected from date of surgery to date of early termination, which was up to the 2 Year timepoint for the earliest enrolled subject.
No difference of adverse event definition.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Trident II Tritanium Acetabular Shell for Revision | Trident II Tritanium Acetabular Shell for Revision: A hemispherical acetabular shell indicated for cementless application in a previously failed total hip arthroplasty (THA) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Joint Infection | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
Not provided
Limitation: Early termination leading to small numbers of subjects analyzed due to lack of enrollment.
The Secondary Outcome of Radiographic Stability was corrected and adjusted to tabular presentation in alignment with the pre-specified endpoint in the study protocol, which is a composite endpoint of both Radiolucency and Migration. Radiographic Radiolucency as a standalone Secondary Outcome Measure was erroneously submitted in the original posting.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Barga | Stryker | 2018315073 | kevin.barga@stryker.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 9, 2019 | Jun 27, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 9, 2019 | Oct 6, 2023 | ICF_002.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D024162 | Second-Look Surgery |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| New Orleans |
| Louisiana |
| 70121 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Massachusetts | Worcester | Massachusetts | 01605 | United States |
| Beaumont Hospital Research Institute | Royal Oak | Michigan | 48073 | United States |
| The Orthopaedic & Fracture Clinic, P.A. | Mankato | Minnesota | 56001 | United States |
| Reno Orthopedic Center Foundation | Reno | Nevada | 89503 | United States |
| OrthoNY | Albany | New York | 12205 | United States |
| Syracuse Orthopedic Specialists | New York | New York | 13214 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| Hips Implanted |
|
| years |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants | Participants |
|
Trident II Tritanium Acetabular Shell for Revision: A hemispherical acetabular shell indicated for cementless application in a previously failed total hip arthroplasty (THA)
|
|
| Secondary | Radiographic Stability | Radiographic stability is a composite endpoint evaluating radiolucency and migration. Radiographic stability is defined as cases (hips implanted) which do not present with migration of greater than 5 mm in any direction or at least 2 mm radiolucency in all zones. | Data reviewed by Independent Radiographic Reviewer is presented for one subject (1 Hip Implanted) at the 6 week and 3-6 Month timepoint. Following the initial review of 1 subject, the decision to terminate the study was made. No further radiographic review was conducted, and no additional radiographic stability data was collected. | Posted | Count of Units | Hips Implanted | 6 Weeks and 3-6 Months | Hips Implanted | Hips Implanted |
|
|
|
| 0 |
| 14 |
| 1 |
| 14 |
| 0 |
| 14 |
Not provided