Arthroplasty, Replacement, Hip
Conditions
Brief summary
The purpose of the Post Approval Study of the ABC and Trident® systems is to continue to demonstrate the safety and efficacy of the alumina-on-alumina bearing surfaces combined with the appropriate shell in a cementless application.
Detailed description
The ABC/ Trident® study was initiated in 1996 as an FDA IDE pre-market study in the United States for alumina bearing THR. PreMarket Approval (PMA)application was approved in February 3,2003. The Post Approval Study (PAS) involved six surgeon investigators from the original IDE study. Subjects who consented to participate in the Post Approval Study continued to be followed to collect limited patient reported data regarding status of the hip.
Interventions
DEVICETrident® Ceramic Insert/Trident® AD HA Acetabular Shell
Trident® Ceramic Insert/Trident® AD HA Acetabular Shell
DEVICEAlumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell
Alumina Insert/PSL® Microstructured Acetabular Shell or Secur-Fit® HA PSL® Acetabular Shell
DEVICEOmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell
OmniFit® Series II Insert/OmniFit® PSL® Microstructured Acetabular Shell
Sponsors
Stryker Orthopaedics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The individual has signed a Patient Informed Consent (PIC), specific to this study, and approved by the Institutional Review Board (IRB). * The individual is between the ages of 21 and 75 years. * The individual is not classified as morbidly obese. * The individual clinically qualifies for total hip arthroplastic surgery based on physical examination and medical history. * The individual is diagnosed with a primary diagnosis of Non-Inflammatory Degenerative Joint Disease (osteoarthritis, traumatic arthritis, avascular necrosis, slipped capital epiphysis, pelvic fracture, femoral fracture, failed fracture fixation or diastrophic variant). * The individual does not have an active infection within the affected hip joint. * The individual has not had a previous total hip replacement or hip fusion to the affected hip joint. * The individual is physically and mentally willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation (i.e., not currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, presence of alcohol or substance abuse). * The individual does not have a neuromuscular or neurosensory deficiency that limits the ability to evaluate the safety and effectiveness of the device. * The individual does not have a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the study (i.e., moderate to severe osteoporosis, Paget's disease, renal osteodystrophy), is not immunologically suppressed, nor receiving steroids in excess of physiologic dose requirements. * The individual is skeletally mature. * The individual is not pregnant. * The individual is not a prisoner. * The individual has no plans to relocate to another geographic area before the completion of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Component Revision and Complications | 10 years | The number of hips in which the study device was removed and replaced with a new component/s is listed. Complications (adverse events) are listed in the adverse event section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score | 3-5 and 10 Years | Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor. 90 - 100 = excellent 80 - 89 = good 70 - 79 = fair 0 - 69 = poor |
| Radiographic Evaluation | 3-5 and 10 years | Failure is defined as progressive femoral radiolucency (RLL) \> or = 2mm around entire stem, progressive subsidence \> or = 5mm, progressive acetabular radiolucency (RLL) \> or = 2 mm around entire cup, or cup migration \> or = 3mm. |
| Hip Follow-Up Questionnaire | 6-10 years | A three question follow-up questionnaire was administered annually asking whether the participant is satisfied with the study total hip replacement(THR) (noted as satisfied below); whether they have any study hip pain (noted as no pain below); and whether they have had any surgery on the study hip during the previous year noted as no surgery below). |
Countries
United States
Participant flow
Pre-assignment details
There were 413/464 participants/hips enrolled. Started, completed and not completed counts are reported by hip.
Participants by arm
| Arm | Count |
|---|---|
| Trident System Trident Ceramic Insert/Trident AD with PureFix HA Shell | 190 |
| ABC System Howmedica Osteonics Alumina Insert/either PSL Microstructured or Secur Fit HA PSL Shell | 185 |
| Control Howmedica Osteonics Omnifit Series II Cup Inserts/Omnifit PSL Microstructured Shell | 89 |
| Total | 464 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 7 | 4 | 1 |
| Overall Study | Lost to Follow-up | 8 | 14 | 8 |
| Overall Study | Missing 10 year data | 20 | 1 | 1 |
| Overall Study | Revision of study component | 2 | 2 | 2 |
| Overall Study | Unwilling/Unable to return | 1 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 4 | 0 |
Baseline characteristics
| Characteristic | Trident System | ABC System | Control | Total |
|---|---|---|---|---|
| Age, Continuous | 51.5 years | 53.9 years | 54.7 years | 53.08 years |
| Region of Enrollment United States | 190 hips | 185 hips | 89 hips | 464 hips |
| Sex/Gender, Customized Female | 67 hips | 64 hips | 35 hips | 166 hips |
| Sex/Gender, Customized Male | 123 hips | 121 hips | 54 hips | 298 hips |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 36 / 190 | 17 / 185 | 7 / 89 | 0 / 413 |
| serious Total, serious adverse events | 1 / 190 | 1 / 185 | 1 / 89 | 1 / 413 |
Outcome results
Primary
Component Revision and Complications
The number of hips in which the study device was removed and replaced with a new component/s is listed. Complications (adverse events) are listed in the adverse event section.
Time frame: 10 years
Population: Number of participants analyzed includes all subjects enrolled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trident® System | Component Revision and Complications | 2 hips |
| ABC System | Component Revision and Complications | 2 hips |
| Control | Component Revision and Complications | 2 hips |
Comparison: To compare the Kaplan-Meier survivorship between the two systemsp-value: 0.0832Log Rank
Comparison: To compare the Kaplan-Meier survivorship between the two systemsp-value: 0.1657Log Rank
Secondary
Harris Hip Score
Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score less than or equal to 79 is considered fair-poor. 90 - 100 = excellent 80 - 89 = good 70 - 79 = fair 0 - 69 = poor
Time frame: 3-5 and 10 Years
Population: Participants may have one or both hips replaced. Number of participants and hips analyzed include all enrolled. Number of hips with HHS evaluated at postoperative periods indicated is included in the outcome results posting.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trident® System | Harris Hip Score | 4 yr hips with a good-excellent score (80-100) | 148 hips |
| Trident® System | Harris Hip Score | 3 yr hips with good-excellent score (80-100) | 160 hips |
| Trident® System | Harris Hip Score | 4 yr hips with a fair-poor score (0-79) | 6 hips |
| Trident® System | Harris Hip Score | 10 yr hips with a fair-poor score (0-79) | 0 hips |
| Trident® System | Harris Hip Score | 3 yr hips with a fair-poor score (0-79) | 2 hips |
| Trident® System | Harris Hip Score | 5 yr hips with a good-excellent score (80-100) | 126 hips |
| Trident® System | Harris Hip Score | 10 yr hips with a good-excellent score (80-100) | 67 hips |
| Trident® System | Harris Hip Score | 5 yr hips with a fair-poor score (0-79) | 6 hips |
| ABC System | Harris Hip Score | 3 yr hips with a fair-poor score (0-79) | 2 hips |
| ABC System | Harris Hip Score | 5 yr hips with a fair-poor score (0-79) | 4 hips |
| ABC System | Harris Hip Score | 3 yr hips with good-excellent score (80-100) | 171 hips |
| ABC System | Harris Hip Score | 10 yr hips with a good-excellent score (80-100) | 115 hips |
| ABC System | Harris Hip Score | 10 yr hips with a fair-poor score (0-79) | 4 hips |
| ABC System | Harris Hip Score | 4 yr hips with a good-excellent score (80-100) | 164 hips |
| ABC System | Harris Hip Score | 4 yr hips with a fair-poor score (0-79) | 2 hips |
| ABC System | Harris Hip Score | 5 yr hips with a good-excellent score (80-100) | 158 hips |
| Control | Harris Hip Score | 4 yr hips with a fair-poor score (0-79) | 2 hips |
| Control | Harris Hip Score | 3 yr hips with good-excellent score (80-100) | 81 hips |
| Control | Harris Hip Score | 3 yr hips with a fair-poor score (0-79) | 2 hips |
| Control | Harris Hip Score | 4 yr hips with a good-excellent score (80-100) | 77 hips |
| Control | Harris Hip Score | 10 yr hips with a fair-poor score (0-79) | 2 hips |
| Control | Harris Hip Score | 5 yr hips with a good-excellent score (80-100) | 76 hips |
| Control | Harris Hip Score | 5 yr hips with a fair-poor score (0-79) | 2 hips |
| Control | Harris Hip Score | 10 yr hips with a good-excellent score (80-100) | 56 hips |
Comparison: To compare the # of cases at 10 years for those that have a HHS ≥ 80 to those that have \< 80 for all three armsp-value: 0.3701Fisher Exact
Secondary
Hip Follow-Up Questionnaire
A three question follow-up questionnaire was administered annually asking whether the participant is satisfied with the study total hip replacement(THR) (noted as satisfied below); whether they have any study hip pain (noted as no pain below); and whether they have had any surgery on the study hip during the previous year noted as no surgery below).
Time frame: 6-10 years
Population: Participants may have one or both hips replaced. Number of participants/hips analyzed includes all enrolled. Number of hips with positive three question responses at postoperative periods indicated is included in the outcome results posting. Number of hips available for evaluation is indicated in the results heading by postoperative period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trident® System | Hip Follow-Up Questionnaire | 7 yr no pain (Trident ®166/ABC 146/Control 71) | 138 hips |
| Trident® System | Hip Follow-Up Questionnaire | 9yr no surgery (Trident ®150/ABC 162/Control 83) | 150 hips |
| Trident® System | Hip Follow-Up Questionnaire | 6yr no pain (Trident ®168/ABC 150/Control 79) | 142 hips |
| Trident® System | Hip Follow-Up Questionnaire | 7 yr no surgery (Trident® 166/ABC 146/Control 71) | 165 hips |
| Trident® System | Hip Follow-Up Questionnaire | 10yr no pain (Trident ®143/ABC 148/Control 76) | 123 hips |
| Trident® System | Hip Follow-Up Questionnaire | 9yr no pain (Trident ®150/ABC 162/Control 83) | 128 hips |
| Trident® System | Hip Follow-Up Questionnaire | 8yr satisfied (Trident ®164/ABC 141/Control 75) | 160 hips |
| Trident® System | Hip Follow-Up Questionnaire | 7yr satisfied (Trident ®166/ABC 146/Control 71) | 161 hips |
| Trident® System | Hip Follow-Up Questionnaire | 6yr satisfied (Trident ®168/ABC 150/Control 79) | 163 hips |
| Trident® System | Hip Follow-Up Questionnaire | 8yr no pain (Trident ®164/ABC 141/Control 75) | 140 hips |
| Trident® System | Hip Follow-Up Questionnaire | 10yr no surgery (Trident ®143/ABC 148/Control 76) | 143 hips |
| Trident® System | Hip Follow-Up Questionnaire | 10yr satisfied (Trident ®143/ABC 148/Control 76) | 142 hips |
| Trident® System | Hip Follow-Up Questionnaire | 6yr no surgery (Trident ®168/ABC 150/Control 79) | 168 hips |
| Trident® System | Hip Follow-Up Questionnaire | 9yr satisfied (Trident ®150/ABC 162/Control 83) | 148 hips |
| Trident® System | Hip Follow-Up Questionnaire | 8yr no surgery (Trident ®164/ABC 141/Control 75) | 164 hips |
| ABC System | Hip Follow-Up Questionnaire | 9yr satisfied (Trident ®150/ABC 162/Control 83) | 161 hips |
| ABC System | Hip Follow-Up Questionnaire | 9yr no pain (Trident ®150/ABC 162/Control 83) | 150 hips |
| ABC System | Hip Follow-Up Questionnaire | 6yr satisfied (Trident ®168/ABC 150/Control 79) | 146 hips |
| ABC System | Hip Follow-Up Questionnaire | 9yr no surgery (Trident ®150/ABC 162/Control 83) | 162 hips |
| ABC System | Hip Follow-Up Questionnaire | 10yr satisfied (Trident ®143/ABC 148/Control 76) | 148 hips |
| ABC System | Hip Follow-Up Questionnaire | 10yr no pain (Trident ®143/ABC 148/Control 76) | 136 hips |
| ABC System | Hip Follow-Up Questionnaire | 7yr satisfied (Trident ®166/ABC 146/Control 71) | 145 hips |
| ABC System | Hip Follow-Up Questionnaire | 10yr no surgery (Trident ®143/ABC 148/Control 76) | 148 hips |
| ABC System | Hip Follow-Up Questionnaire | 7 yr no pain (Trident ®166/ABC 146/Control 71) | 130 hips |
| ABC System | Hip Follow-Up Questionnaire | 7 yr no surgery (Trident® 166/ABC 146/Control 71) | 145 hips |
| ABC System | Hip Follow-Up Questionnaire | 6yr no pain (Trident ®168/ABC 150/Control 79) | 129 hips |
| ABC System | Hip Follow-Up Questionnaire | 8yr satisfied (Trident ®164/ABC 141/Control 75) | 141 hips |
| ABC System | Hip Follow-Up Questionnaire | 8yr no pain (Trident ®164/ABC 141/Control 75) | 127 hips |
| ABC System | Hip Follow-Up Questionnaire | 8yr no surgery (Trident ®164/ABC 141/Control 75) | 141 hips |
| ABC System | Hip Follow-Up Questionnaire | 6yr no surgery (Trident ®168/ABC 150/Control 79) | 147 hips |
| Control | Hip Follow-Up Questionnaire | 8yr no surgery (Trident ®164/ABC 141/Control 75) | 75 hips |
| Control | Hip Follow-Up Questionnaire | 10yr satisfied (Trident ®143/ABC 148/Control 76) | 76 hips |
| Control | Hip Follow-Up Questionnaire | 6yr satisfied (Trident ®168/ABC 150/Control 79) | 76 hips |
| Control | Hip Follow-Up Questionnaire | 6yr no pain (Trident ®168/ABC 150/Control 79) | 63 hips |
| Control | Hip Follow-Up Questionnaire | 6yr no surgery (Trident ®168/ABC 150/Control 79) | 79 hips |
| Control | Hip Follow-Up Questionnaire | 7yr satisfied (Trident ®166/ABC 146/Control 71) | 71 hips |
| Control | Hip Follow-Up Questionnaire | 7 yr no pain (Trident ®166/ABC 146/Control 71) | 58 hips |
| Control | Hip Follow-Up Questionnaire | 7 yr no surgery (Trident® 166/ABC 146/Control 71) | 71 hips |
| Control | Hip Follow-Up Questionnaire | 8yr satisfied (Trident ®164/ABC 141/Control 75) | 73 hips |
| Control | Hip Follow-Up Questionnaire | 8yr no pain (Trident ®164/ABC 141/Control 75) | 68 hips |
| Control | Hip Follow-Up Questionnaire | 9yr satisfied (Trident ®150/ABC 162/Control 83) | 83 hips |
| Control | Hip Follow-Up Questionnaire | 9yr no pain (Trident ®150/ABC 162/Control 83) | 73 hips |
| Control | Hip Follow-Up Questionnaire | 9yr no surgery (Trident ®150/ABC 162/Control 83) | 83 hips |
| Control | Hip Follow-Up Questionnaire | 10yr no pain (Trident ®143/ABC 148/Control 76) | 65 hips |
| Control | Hip Follow-Up Questionnaire | 10yr no surgery (Trident ®143/ABC 148/Control 76) | 76 hips |
Comparison: Compare the # of cases at 10 years satisfied with their total hip replacement for all three groupsp-value: 0.6011Fisher Exact
Comparison: Compare the # of cases at 10 years for having pain in their hip for all three groupsp-value: 0.206Fisher Exact
Secondary
Radiographic Evaluation
Failure is defined as progressive femoral radiolucency (RLL) \> or = 2mm around entire stem, progressive subsidence \> or = 5mm, progressive acetabular radiolucency (RLL) \> or = 2 mm around entire cup, or cup migration \> or = 3mm.
Time frame: 3-5 and 10 years
Population: Participants may have one or both hips replaced. Number of participants/hips analyzed includes all enrolled. Number of hips demonstrating radiographic failure assessment at postoperative periods indicated is included in the outcome results posting. Number of hips available for evaluation is indicated in the results heading by postoperative period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Trident® System | Radiographic Evaluation | 5 yr failure (128 Trident®/158 ABC/74 Control) | 0 hips |
| Trident® System | Radiographic Evaluation | 10 yr failure (60 Trident®/116 ABC/56 Control) | 0 hips |
| Trident® System | Radiographic Evaluation | 4 yr failure (153 Trident®/162 ABC/79 Control) | 0 hips |
| Trident® System | Radiographic Evaluation | 3 yr failure (160 Trident®/174 ABC/82 Control) | 0 hips |
| ABC System | Radiographic Evaluation | 3 yr failure (160 Trident®/174 ABC/82 Control) | 0 hips |
| ABC System | Radiographic Evaluation | 4 yr failure (153 Trident®/162 ABC/79 Control) | 0 hips |
| ABC System | Radiographic Evaluation | 10 yr failure (60 Trident®/116 ABC/56 Control) | 0 hips |
| ABC System | Radiographic Evaluation | 5 yr failure (128 Trident®/158 ABC/74 Control) | 0 hips |
| Control | Radiographic Evaluation | 10 yr failure (60 Trident®/116 ABC/56 Control) | 0 hips |
| Control | Radiographic Evaluation | 3 yr failure (160 Trident®/174 ABC/82 Control) | 0 hips |
| Control | Radiographic Evaluation | 4 yr failure (153 Trident®/162 ABC/79 Control) | 0 hips |
| Control | Radiographic Evaluation | 5 yr failure (128 Trident®/158 ABC/74 Control) | 0 hips |