Arthritis, Rheumatoid
Conditions
Brief summary
Study Title INFINITY™Total Ankle Replacement Follow-up (ITAR) Study Design Prospective, multi-site, multi-year post-market clinical follow-up study Study Group Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY™ Total Ankle System Number of Subjects 150 with 9 sites
Detailed description
The primary outcome measure of this post-market clinical observational study is to collect data relating to the INFINITY™ Total Ankle System survivorship at 10 years. The secondary outcome measures are to characterize the improvements after implantation over a 10 year period using patient reported outcome measures related to quality of life, pain and functional improvements, safety of the implants, as well as radiographic assessments (X-Rays) The outcome measures collected in this study will be analyzed and reported as required for local, regional, and country requirements (i.e., regulatory authorities and notified bodies).
Interventions
None listed
Sponsors
Stryker Trauma and Extremities
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be 21 years of age or older at the time of surgery; * Diagnosed with unilateral and/or bilateral ankle joint disease; * Diagnosed with ankle joint damage from rheumatoid arthritis, post-traumatic, or degenerative arthritis; * Willing and able to consent to participate (written, informed consent; * Willing and able to attend the requested follow-up visits; * A clinical decision has been made to use INFINITY™ Total Ankle System replacement prior to enrollment in the research.
Exclusion criteria
* Subjects with an ankle condition, as determined by the investigator, to be an inappropriate candidate for a total ankle replacement; * Subjects requiring revision total ankle replacement of the ankle being considered for study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survivorship at 10 Years | 10 years | The primary endpoint is a survivorship rate at 10 years as defined with a Kaplan Meier survivorship analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Evaluation-physician Reported Questionnaire | Pre-op through 2 years | Identify and assess the implant for the below: Evidence of Subsidence Evidence Tibia and Talar Subsidence \> 5° Evidence of Radiolucency Evidence Tibia and Talar Linear Radiolucency \> 2mm and document if the Radiolucency is Progressive Evidence of Tibia and Talar Cystic Radiolucency \> 5mm and document if the Radiolucency is Progressive Other Radiographic Findings deemed reportable by Investigator |
| PROMIS Scale v1.2- Global Health | 2 years | PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates andmonitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. (PROMIS Scale v1.2- Global Health) The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the T-Score. The average TScore for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. Will report change from baseline score to 2 years. |
| Ankle Osteoarthritis Score (AOS) | Pre-op though 2 years | AOS is a reliable, validated, visual analog-based, disease-specific self-administered instrument designed specifically to measure disability and pain from ankle osteoarthritis. Both Pain and Disability components are used to calculate the total score. The score is from zero to one hundred with a lower score indicating more normal function. A minimal clinically important difference (MCID) for the Total AOS score reduction from baseline has been established: 12.35 points. Will report change from baseline score to 2 years. |
| FAOS Questionnaire | 2 years | The FAOS is a self-report measure that evaluates symptoms and functional limitations in individuals with generalized foot and ankle disorders. The FAOS is composed of the following 5 subscales: pain (9 items), other symptoms (7 items), activities of daily living (7 items), sports and recreational activities (5 items), and foot and ankle-related quality of life (4 items). All subscales have a range from 0 (severe symptoms) to 100 (no symptoms). The total FAOS score is calculated by summing up the scores from each of the five subscales (pain, other symptoms, activities of daily living, sports and recreation, and quality of life) after individually calculating each subscale score by adding up the points from its respective questions and dividing by the maximum possible score for that subscale; the final result is then normalized to a scale from 0 (severe symptoms) to 100 (no symptoms) based on the total score across all subscales. We report change from baseline score to 2 years. |
| TAR Satisfaction Questionnaire | Pre-op through 2 years | Compare satisfaction of total ankle replacement post operatively utilizing a four point scale |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| INFINITY™ Total Ankle System Study subjects included those with ankle joints damaged by severe rheumatoid arthritis, post-traumatic disease, and degenerative arthritis and implanted with the INFINITY™ Total Ankle System. | 148 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 6 |
| Overall Study | Didn't Receive Study Device | 7 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Site Closure | 26 |
| Overall Study | Sponsor Closure | 107 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | INFINITY™ Total Ankle System |
|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 9.39 |
| BMI | 31.03 kg/m^2 STANDARD_DEVIATION 5.17 |
| Primary Diagnosis Degenerative Arthritis | 72 Participants |
| Primary Diagnosis Other | 1 Participants |
| Primary Diagnosis Post Traumatic Arthritis | 71 Participants |
| Primary Diagnosis Rheumatoid Arthritis | 4 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants |
| Race/Ethnicity, Customized Race Hispanic | 1 Participants |
| Race/Ethnicity, Customized Race Multi-racial | 0 Participants |
| Race/Ethnicity, Customized Race Other | 7 Participants |
| Race/Ethnicity, Customized Race White | 139 Participants |
| Sex: Female, Male Female | 67 Participants |
| Sex: Female, Male Male | 81 Participants |
| Smoking Status Current, <= 1 Pack/day | 4 Participants |
| Smoking Status Never | 94 Participants |
| Smoking Status Previous | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 148 |
| other Total, other adverse events | 33 / 148 |
| serious Total, serious adverse events | 9 / 148 |
Outcome results
Primary
Survivorship at 10 Years
The primary endpoint is a survivorship rate at 10 years as defined with a Kaplan Meier survivorship analysis.
Time frame: 10 years
Population: Since the study was prematurely discontinued where the maximum subject follow-up is two years, no survival analysis was conducted.
Secondary
Ankle Osteoarthritis Score (AOS)
AOS is a reliable, validated, visual analog-based, disease-specific self-administered instrument designed specifically to measure disability and pain from ankle osteoarthritis. Both Pain and Disability components are used to calculate the total score. The score is from zero to one hundred with a lower score indicating more normal function. A minimal clinically important difference (MCID) for the Total AOS score reduction from baseline has been established: 12.35 points. Will report change from baseline score to 2 years.
Time frame: Pre-op though 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INFINITY™ Total Ankle System | Ankle Osteoarthritis Score (AOS) | -39 Change in score from baseline | Standard Deviation 21.2 |
Secondary
FAOS Questionnaire
The FAOS is a self-report measure that evaluates symptoms and functional limitations in individuals with generalized foot and ankle disorders. The FAOS is composed of the following 5 subscales: pain (9 items), other symptoms (7 items), activities of daily living (7 items), sports and recreational activities (5 items), and foot and ankle-related quality of life (4 items). All subscales have a range from 0 (severe symptoms) to 100 (no symptoms). The total FAOS score is calculated by summing up the scores from each of the five subscales (pain, other symptoms, activities of daily living, sports and recreation, and quality of life) after individually calculating each subscale score by adding up the points from its respective questions and dividing by the maximum possible score for that subscale; the final result is then normalized to a scale from 0 (severe symptoms) to 100 (no symptoms) based on the total score across all subscales. We report change from baseline score to 2 years.
Time frame: 2 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INFINITY™ Total Ankle System | FAOS Questionnaire | Total FAOS Score | 75.5 Scores on a Scale | Standard Deviation 18.6 |
| INFINITY™ Total Ankle System | FAOS Questionnaire | Total Symptoms Score | 75.0 Scores on a Scale | Standard Deviation 20.4 |
| INFINITY™ Total Ankle System | FAOS Questionnaire | Total Pain Score | 82.4 Scores on a Scale | Standard Deviation 18.7 |
| INFINITY™ Total Ankle System | FAOS Questionnaire | Total Activities of Daily Living Score | 87.2 Scores on a Scale | Standard Deviation 16.7 |
| INFINITY™ Total Ankle System | FAOS Questionnaire | Total Sport/Recreation Score | 63.2 Scores on a Scale | Standard Deviation 29.9 |
| INFINITY™ Total Ankle System | FAOS Questionnaire | Total QOL Score | 69.1 Scores on a Scale | Standard Deviation 24.4 |
Secondary
PROMIS Scale v1.2- Global Health
PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates andmonitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. (PROMIS Scale v1.2- Global Health) The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the T-Score. The average TScore for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient. Will report change from baseline score to 2 years.
Time frame: 2 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| INFINITY™ Total Ankle System | PROMIS Scale v1.2- Global Health | Total Global Physical Health | 50.9 Total T-score | Standard Deviation 8.51 |
| INFINITY™ Total Ankle System | PROMIS Scale v1.2- Global Health | Total Global Mental Score | 53.4 Total T-score | Standard Deviation 9.23 |
Secondary
Radiographic Evaluation-physician Reported Questionnaire
Identify and assess the implant for the below: Evidence of Subsidence Evidence Tibia and Talar Subsidence \> 5° Evidence of Radiolucency Evidence Tibia and Talar Linear Radiolucency \> 2mm and document if the Radiolucency is Progressive Evidence of Tibia and Talar Cystic Radiolucency \> 5mm and document if the Radiolucency is Progressive Other Radiographic Findings deemed reportable by Investigator
Time frame: Pre-op through 2 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| INFINITY™ Total Ankle System | Radiographic Evaluation-physician Reported Questionnaire | Subsidence | 2 Participants |
| INFINITY™ Total Ankle System | Radiographic Evaluation-physician Reported Questionnaire | No Radiographic Finding | 80 Participants |
| INFINITY™ Total Ankle System | Radiographic Evaluation-physician Reported Questionnaire | Any Evidence of Radiolucency < 2mm linear and <5mm cystic radiolucency | 20 Participants |
| INFINITY™ Total Ankle System | Radiographic Evaluation-physician Reported Questionnaire | Other | 10 Participants |
| INFINITY™ Total Ankle System | Radiographic Evaluation-physician Reported Questionnaire | Tibia: linear radiolucency > 2mm | 2 Participants |
| INFINITY™ Total Ankle System | Radiographic Evaluation-physician Reported Questionnaire | Talus: linear radiolucency > 2mm | 1 Participants |
| INFINITY™ Total Ankle System | Radiographic Evaluation-physician Reported Questionnaire | Tibia: linear radiolucency Progressive | 0 Participants |
| INFINITY™ Total Ankle System | Radiographic Evaluation-physician Reported Questionnaire | Talus: linear radiolucency Progressive | 0 Participants |
| INFINITY™ Total Ankle System | Radiographic Evaluation-physician Reported Questionnaire | Talus: cystic radiolucency > 5mm | 0 Participants |
| INFINITY™ Total Ankle System | Radiographic Evaluation-physician Reported Questionnaire | Tibia: cystic radiolucency > 5mm | 0 Participants |
| INFINITY™ Total Ankle System | Radiographic Evaluation-physician Reported Questionnaire | Talus: cystic radiolucency Progessive | 0 Participants |
| INFINITY™ Total Ankle System | Radiographic Evaluation-physician Reported Questionnaire | Tibia: cystic radiolucency Progessive | 0 Participants |
| INFINITY™ Total Ankle System | Radiographic Evaluation-physician Reported Questionnaire | Tibia Subsidence >5 | 0 Participants |
| INFINITY™ Total Ankle System | Radiographic Evaluation-physician Reported Questionnaire | Talus Subsidence >5 | 0 Participants |
Secondary
TAR Satisfaction Questionnaire
Compare satisfaction of total ankle replacement post operatively utilizing a four point scale
Time frame: Pre-op through 2 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| INFINITY™ Total Ankle System | TAR Satisfaction Questionnaire | Excellent | 81 Participants |
| INFINITY™ Total Ankle System | TAR Satisfaction Questionnaire | Good | 22 Participants |
| INFINITY™ Total Ankle System | TAR Satisfaction Questionnaire | Fair | 3 Participants |
| INFINITY™ Total Ankle System | TAR Satisfaction Questionnaire | Poor | 4 Participants |