Arthroplasty, Replacement, Hip
Conditions
Brief summary
The purpose of this study is to evaluate a hip implant system used when a previous hip replacement surgery has failed.
Detailed description
Total hip replacement is considered to be a very successful surgical procedure for the treatment of degenerative joint disease. Clinical results for cementless acetabular components have demonstrated excellent long-term fixation of these devices. However, so called 'first generation' cementless acetabular components have not had similar success rates. In these cases the acetabular component is often revised due to loosening, wear or infection. Revision hip arthroplasty also becomes a challenge as patients often present with severe bone loss and poor bone quality. This can lead to compromised initial stability, which in turn leads to lack of long-term fixation and failure. Acetabular revision with a cementless component has shown improved results over cemented fixation. Radiographic evaluation of the Trident® Tritanium™ Acetabular Shell will provide valuable early to intermediate information that may help predict the long-term success of this new system. It is the intention of this study to closely follow subjects that have undergone revision hip replacement with regard to implant survivorship, signs of radiographic loosening, subjects' function evaluated through Harris Hip Score and Lower Extremity Activity Scale, subject quality of life through SF-36 and adverse events. The primary efficacy hypothesis is that the rate of revision or pending revision (as defined by radiographic parameters) due to instability or lack of fixation for the Trident® Tritanium™ Acetabular Shell will be less than 10% at 5 years.
Interventions
DEVICETrident® Tritanium™ Acetabular Shell
Trident® Tritanium™ Acetabular Shell
Sponsors
Stryker Orthopaedics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Males and non-pregnant females, 21-85 years of age at the time of surgery. 2. Patient is a candidate for a revision of a failed acetabular component with a cementless acetabular component. 3. Patient has signed an IRB approved study consent form. 4. Patient is willing and able to comply with postoperative requirements including postoperative weight bearing restrictions and self-evaluations.
Exclusion criteria
1. Patient is morbidly obese, BMI \> 40. 2. Patient has a systemic or metabolic bone disorder leading to progressive bone deterioration. 3. Patient is immunologically compromised or receiving steroids in excess of normal physiological requirements (\> 30 days). 4. Patient's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis. 5. Patient has an active or suspected latent infection on or about the hip joint. 6. Patient is a prisoner.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Hips Requiring Revision or Pending Revision of the Acetabular Shell (as Defined by Radiographic Parameters) Due to Instability or Lack of Fixation | 5 years post-operative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits | pre-op, 3 month, 1, 2, 3, 4, 5 years | The change in HHS is reported by comparing the mean pre-operative, 3-month, 1, 2, 3, 4, and 5 year post-operative scores. Scores can range from 0 to 100, with 0 being the worst and 100 being the best score. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor. |
| Change in SF-36 From Pre-operative to Post-operative Visits | pre-op, 3 month, 1, 2, 3, 4, 5 years | The change in SF-36 is reported by comparing the mean preoperative, 3 month, 1, 2, 3, 4, and 5 year scores. The SF-36 Health Survey is a 36 item patient-completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state. |
| Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones | 3 month, 1, 2, 3, 4, 5 years | Defined as a lucent area seen parallel and in close proximity to the device at the prosthesis/bone interface encompassing at least 50% of the zone, and at least 1 mm or greater in width. May be accompanied by a radiopaque (reactive) line. Assessed for each of the three modified DeLee Charnley zones. |
| Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction | 3 month, 1, 2, 3, 4, 5 years | Defined as the measurable change in the acetabular shell position relative to reproducible bony landmarks. |
| Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative | pre-op, 3 month, 1, 2, 3, 4, 5 years | The change in LEAS is reported by comparing the mean pre-operative, 3 month, 1, 2, 3, 4, and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level. |
Countries
United States
Participant flow
Pre-assignment details
241 patients/245 hips - 51 patients/52 hips censored = 190 patients/193 hips followed
Participants by arm
| Arm | Count |
|---|---|
| Trident® Tritanium™ Acetabular Shell Trident® Tritanium™ Acetabular Shell used in revision total hip replacement | 190 |
| Total | 190 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 15 |
| Overall Study | Lost to Follow-up | 29 |
| Overall Study | Removal/revision of study component | 8 |
| Overall Study | Subject terminated | 31 |
| Overall Study | Unable to return | 2 |
| Overall Study | Withdrawal by Subject | 20 |
Baseline characteristics
| Characteristic | Trident® Tritanium™ Acetabular Shell |
|---|---|
| Age, Continuous | 63.70 years STANDARD_DEVIATION 11.45 |
| Region of Enrollment United States | 190 Participants |
| Sex: Female, Male Female | 85 Participants |
| Sex: Female, Male Male | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 193 | 0 / 190 |
| serious Total, serious adverse events | 28 / 193 | 41 / 190 |
Outcome results
Primary
Number of Hips Requiring Revision or Pending Revision of the Acetabular Shell (as Defined by Radiographic Parameters) Due to Instability or Lack of Fixation
Time frame: 5 years post-operative
Population: No cases were pending revision.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Trident® Tritanium™ Acetabular Shell | Number of Hips Requiring Revision or Pending Revision of the Acetabular Shell (as Defined by Radiographic Parameters) Due to Instability or Lack of Fixation | 4 hips |
90% CI: [1.07, 5.46]
Secondary
Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits
The change in HHS is reported by comparing the mean pre-operative, 3-month, 1, 2, 3, 4, and 5 year post-operative scores. Scores can range from 0 to 100, with 0 being the worst and 100 being the best score. 90-100 = excellent, 80-89 = good, 70-79 = fair, 0-69 = poor.
Time frame: pre-op, 3 month, 1, 2, 3, 4, 5 years
Population: Participants/hips with available data. Overall number of participants and units analyzed is based upon the preoperative population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trident® Tritanium™ Acetabular Shell | Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits | Mean HHS score preoperative | 53.40 units on a scale | Standard Deviation 21.99 |
| Trident® Tritanium™ Acetabular Shell | Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits | Mean HHS score 3 months | 79.46 units on a scale | Standard Deviation 16.58 |
| Trident® Tritanium™ Acetabular Shell | Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits | Mean HHS score 1 year | 86.11 units on a scale | Standard Deviation 14.83 |
| Trident® Tritanium™ Acetabular Shell | Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits | Mean HHS score 2 years | 85.34 units on a scale | Standard Deviation 15.6 |
| Trident® Tritanium™ Acetabular Shell | Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits | Mean HHS score 3 years | 86.56 units on a scale | Standard Deviation 15.4 |
| Trident® Tritanium™ Acetabular Shell | Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits | Mean HHS score 4 years | 83.87 units on a scale | Standard Deviation 17.32 |
| Trident® Tritanium™ Acetabular Shell | Change in Harris Hip Score (HHS) From Pre-operative to Post-operative Visits | Mean HHS score 5 years | 86.29 units on a scale | Standard Deviation 14.43 |
p-value: <0.0001t-test, 2 sided
Secondary
Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative
The change in LEAS is reported by comparing the mean pre-operative, 3 month, 1, 2, 3, 4, and 5 year scores. The LEAS is completed by the participant to assess activity level. Activity levels were ordered in terms of intensity from 1 to 18, with 18 indicating the highest activity level.
Time frame: pre-op, 3 month, 1, 2, 3, 4, 5 years
Population: Participants/hips with available data. Overall number of participants and hips analysed is based upon the preoperative population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trident® Tritanium™ Acetabular Shell | Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative | LEAS preoperative | 8.32 units on a scale | Standard Deviation 3.27 |
| Trident® Tritanium™ Acetabular Shell | Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative | LEAS 3 month | 9.25 units on a scale | Standard Deviation 2.74 |
| Trident® Tritanium™ Acetabular Shell | Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative | LEAS 1 year | 10.5 units on a scale | Standard Deviation 2.95 |
| Trident® Tritanium™ Acetabular Shell | Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative | LEAS 2 years | 10.37 units on a scale | Standard Deviation 3.25 |
| Trident® Tritanium™ Acetabular Shell | Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative | LEAS 3 years | 10.6 units on a scale | Standard Deviation 3.26 |
| Trident® Tritanium™ Acetabular Shell | Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative | LEAS 4 years | 10.25 units on a scale | Standard Deviation 3.18 |
| Trident® Tritanium™ Acetabular Shell | Change in Lower Extremity Activity Scale (LEAS) From Pre-operative to Post-operative | LEAS 5 years | 10.15 units on a scale | Standard Deviation 3.16 |
p-value: 0.0011t-test, 2 sided
p-value: <0.0001t-test, 2 sided
p-value: 0.0002t-test, 2 sided
p-value: 0.0009t-test, 2 sided
Secondary
Change in SF-36 From Pre-operative to Post-operative Visits
The change in SF-36 is reported by comparing the mean preoperative, 3 month, 1, 2, 3, 4, and 5 year scores. The SF-36 Health Survey is a 36 item patient-completed questionnaire to measure general health and well-being. It includes a physical and mental status component score; each ranging from 0-100. Low values represent a poor health state and high values represent a good health state.
Time frame: pre-op, 3 month, 1, 2, 3, 4, 5 years
Population: Participants/hips with available data. Overall number of participants and hips analyzed is based upon the preoperative population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trident® Tritanium™ Acetabular Shell | Change in SF-36 From Pre-operative to Post-operative Visits | Physical score preoperative | 33.26 units on a scale | Standard Deviation 10.36 |
| Trident® Tritanium™ Acetabular Shell | Change in SF-36 From Pre-operative to Post-operative Visits | Physical score 3 months | 38.9 units on a scale | Standard Deviation 10.7 |
| Trident® Tritanium™ Acetabular Shell | Change in SF-36 From Pre-operative to Post-operative Visits | Physical score 1 year | 43.04 units on a scale | Standard Deviation 10.31 |
| Trident® Tritanium™ Acetabular Shell | Change in SF-36 From Pre-operative to Post-operative Visits | Physical score 4 years | 42.76 units on a scale | Standard Deviation 11.27 |
| Trident® Tritanium™ Acetabular Shell | Change in SF-36 From Pre-operative to Post-operative Visits | Physical score 5 years | 43.82 units on a scale | Standard Deviation 11.4 |
| Trident® Tritanium™ Acetabular Shell | Change in SF-36 From Pre-operative to Post-operative Visits | Mental score preoperative | 49.56 units on a scale | Standard Deviation 13.08 |
| Trident® Tritanium™ Acetabular Shell | Change in SF-36 From Pre-operative to Post-operative Visits | Mental score 3 months | 52.07 units on a scale | Standard Deviation 11.4 |
| Trident® Tritanium™ Acetabular Shell | Change in SF-36 From Pre-operative to Post-operative Visits | Mental score 1 year | 52.81 units on a scale | Standard Deviation 10.44 |
| Trident® Tritanium™ Acetabular Shell | Change in SF-36 From Pre-operative to Post-operative Visits | Mental score 2 years | 53.37 units on a scale | Standard Deviation 10.22 |
| Trident® Tritanium™ Acetabular Shell | Change in SF-36 From Pre-operative to Post-operative Visits | Mental score 3 years | 53.84 units on a scale | Standard Deviation 9.67 |
| Trident® Tritanium™ Acetabular Shell | Change in SF-36 From Pre-operative to Post-operative Visits | Mental score 4 years | 53.63 units on a scale | Standard Deviation 10.29 |
| Trident® Tritanium™ Acetabular Shell | Change in SF-36 From Pre-operative to Post-operative Visits | Mental score 5 years | 52.93 units on a scale | Standard Deviation 9.25 |
| Trident® Tritanium™ Acetabular Shell | Change in SF-36 From Pre-operative to Post-operative Visits | Physical score 2 years | 43.55 units on a scale | Standard Deviation 10.7 |
| Trident® Tritanium™ Acetabular Shell | Change in SF-36 From Pre-operative to Post-operative Visits | Physical score 3 years | 43.54 units on a scale | Standard Deviation 10.29 |
p-value: <0.0001t-test, 2 sided
p-value: 0.0139t-test, 2 sided
p-value: 0.0254t-test, 2 sided
p-value: 0.1506t-test, 2 sided
p-value: 0.0936t-test, 2 sided
p-value: 0.0909t-test, 2 sided
p-value: 0.048t-test, 2 sided
Secondary
Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction
Defined as the measurable change in the acetabular shell position relative to reproducible bony landmarks.
Time frame: 3 month, 1, 2, 3, 4, 5 years
Population: Participants/hips are based on evaluable films for this data point. Overall number of participants and hips is based upon the 3 month population.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Trident® Tritanium™ Acetabular Shell | Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction | Migration >5mm at 3 months | 0 hips |
| Trident® Tritanium™ Acetabular Shell | Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction | Migration >5mm at 1 year | 0 hips |
| Trident® Tritanium™ Acetabular Shell | Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction | Migration >5mm at 2 years | 0 hips |
| Trident® Tritanium™ Acetabular Shell | Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction | Migration >5mm at 3 years | 0 hips |
| Trident® Tritanium™ Acetabular Shell | Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction | Migration >5mm at 4 years | 0 hips |
| Trident® Tritanium™ Acetabular Shell | Radiographic Outcomes: Migration of the Acetabular Shell Greater Than 5 mm in Any Direction | Migration >5mm at 5 years | 0 hips |
Secondary
Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones
Defined as a lucent area seen parallel and in close proximity to the device at the prosthesis/bone interface encompassing at least 50% of the zone, and at least 1 mm or greater in width. May be accompanied by a radiopaque (reactive) line. Assessed for each of the three modified DeLee Charnley zones.
Time frame: 3 month, 1, 2, 3, 4, 5 years
Population: Participants/hips are based on evaluable films for this data point. Overall number of participants and hips analyzed is based upon the 3 month population.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Trident® Tritanium™ Acetabular Shell | Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones | RLL> 2mm in all zones at 3 months | 3 hips |
| Trident® Tritanium™ Acetabular Shell | Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones | RLL> 2mm in all zones at 1 year | 0 hips |
| Trident® Tritanium™ Acetabular Shell | Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones | RLL> 2mm in all zones at 2 years | 0 hips |
| Trident® Tritanium™ Acetabular Shell | Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones | RLL> 2mm in all zones at 3 years | 0 hips |
| Trident® Tritanium™ Acetabular Shell | Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones | RLL> 2mm in all zones at 4 years | 0 hips |
| Trident® Tritanium™ Acetabular Shell | Radiographic Outcomes: Radiolucency (RLL) Around the Acetabular Shell is Greater Than 2 mm in All Zones | RLL> 2mm in all zones at 5 years | 0 hips |