Arthroplasty, Hip Revision
Conditions
Brief summary
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.
Interventions
DEVICETrident II Tritanium Acetabular Shell for Revision
A hemispherical acetabular shell indicated for cementless application in a previously failed total hip arthroplasty (THA)
Sponsors
Stryker Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cases Free From Trident II Acetabular Shell Revision | 6 Weeks, 3-6 Months, 1 Year and 2 Years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Stability | 6 Weeks and 3-6 Months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 14 |
| 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) | 15 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Participants/Hips Implanted Censored from Analysis | 2 |
| Overall Study | Participants Terminated Early (*15 Hips Implanted) | 14 |
Baseline characteristics
| Characteristic | Trident II Tritanium Acetabular Shell for Revision |
|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 8.13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 14 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 1 / 14 |
Outcome results
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.
Time frame: 6 Weeks, 3-6 Months, 1 Year and 2 Years
Population: 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).
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Trident II Tritanium Acetabular Shell for Revision | Number of Cases Free From Trident II Acetabular Shell Revision | Number of Hips Free From Revision at 6 Weeks | 14 Hips Implanted |
| Trident II Tritanium Acetabular Shell for Revision | Number of Cases Free From Trident II Acetabular Shell Revision | Number of Hips Free From Revision at 3-6 Months | 11 Hips Implanted |
| Trident II Tritanium Acetabular Shell for Revision | Number of Cases Free From Trident II Acetabular Shell Revision | Number of Hips Free From Revision at 1 Year | 8 Hips Implanted |
| Trident II Tritanium Acetabular Shell for Revision | Number of Cases Free From Trident II Acetabular Shell Revision | Number of Hips Free From Revision at 2 Years | 2 Hips Implanted |
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.
Time frame: 6 Weeks and 3-6 Months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Trident II Tritanium Acetabular Shell for Revision | Radiographic Stability | Hips Implanted that are Radiographically Stable at 6-Weeks | 1 Hips Implanted |
| Trident II Tritanium Acetabular Shell for Revision | Radiographic Stability | Hips Implanted that are Radiographically Stable at 3-6 Months | 1 Hips Implanted |