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Business Decision
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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
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).
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| Measure | Description | Time Frame |
|---|---|---|
| Survivorship at 10 Years | The primary endpoint is a survivorship rate at 10 years as defined with a Kaplan Meier survivorship analysis. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Primary/Unilateral and/or bilateral Total Ankle Arthroplasty subjects implanted with INFINITY™ Total Ankle System
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Gibson | Stryker Trauma and Extremities | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eisenhower Medical Center | Rancho Mirage | California | 92270 | United States | ||
| Orthopaedic & Spine Center of the Rockies |
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| ID | Title | Description |
|---|---|---|
| FG000 | INFINITY™ Total Ankle System | Study subjects included those withankle joints damaged by severe rheumatoid arthritis, post-traumatic disease, and degenerative arthritis and implanted with the INFINITY™ Total Ankle System. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Of the 155 subjects enrolled, 148 received the study device and were therefore analyzed
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | Survivorship at 10 Years | The primary endpoint is a survivorship rate at 10 years as defined with a Kaplan Meier survivorship analysis. | Since the study was prematurely discontinued where the maximum subject follow-up is two years, no survival analysis was conducted. | Posted | 10 years |
|
|
Surgery to 5 years, 1 month, 13 days
Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Complication associated with device | General disorders | MedDRA (18.0) | Systematic Assessment |
As the study was terminated early, outcomes and adverse events can only be reported up to the date of closure.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Seidman, Manager, Clinical Research | Stryker | 9016338616 | jennifer.seidman@stryker.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 10, 2017 | Apr 16, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 4, 2021 | Apr 16, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Pre-op through 2 years |
| 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. | 2 years |
| 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. | Pre-op though 2 years |
| 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. | 2 years |
| TAR Satisfaction Questionnaire | Compare satisfaction of total ankle replacement post operatively utilizing a four point scale | Pre-op through 2 years |
| Fort Collins |
| Colorado |
| 80525 |
| United States |
| Illinois Bone & Joint Institute | Libertyville | Illinois | 60048 | United States |
| Orthopaedic Associates of Michigan, PC | Grand Rapids | Michigan | 49525 | United States |
| Beaumont Hospital-Royal Oak | Royal Oak | Michigan | 48073 | United States |
| Slocum Center for Orthopedics & Sports Medicine | Eugene | Oregon | 97401 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| UT Erlanger | Chattanooga | Tennessee | 37403 | United States |
| Campbell Clinic | Germantown | Tennessee | 38138 | United States |
| Didn't Receive Study Device |
|
| Site Closure |
|
| Sponsor Closure |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Smoking Status | Count of Participants | Participants |
|
| Primary Diagnosis | Count of Participants | Participants |
|
|
| 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 | Posted | Count of Participants | Participants | Pre-op through 2 years |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Total T-score | 2 years |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Change in score from baseline | Pre-op though 2 years |
|
|
|
| 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. | Posted | Mean | Standard Deviation | Scores on a Scale | 2 years |
|
|
|
| Secondary | TAR Satisfaction Questionnaire | Compare satisfaction of total ankle replacement post operatively utilizing a four point scale | Posted | Count of Participants | Participants | Pre-op through 2 years |
|
|
|
| 0 |
| 148 |
| 9 |
| 148 |
| 33 |
| 148 |
| Periprosthetic osteolysis | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Ankle impingement | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Device loosening | Product Issues | MedDRA (18.0) | Systematic Assessment |
|
| Ankle arthroplasty | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
|
| Ankle operation | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
|
| Implant site hypoaesthesia | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Stress fracture | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Joint instability | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Tendon discomfort | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Nerve compression | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Device loosening | Product Issues | MedDRA (18.0) | Systematic Assessment |
|
| Implant subsidence | Product Issues | MedDRA (18.0) | Systematic Assessment |
|
| Scab | Skin and subcutaneous tissue disorders | MedDRA (18.0) | Systematic Assessment |
|
| Ankle arthroplasty | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
|
| Arthrotomy | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
|
| Cast application | Surgical and medical procedures | MedDRA (18.0) | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Subsidence |
|
| Tibia: linear radiolucency > 2mm |
|
| Talus: linear radiolucency > 2mm |
|
| Tibia: linear radiolucency Progressive |
|
| Talus: linear radiolucency Progressive |
|
| Talus: cystic radiolucency > 5mm |
|
| Tibia: cystic radiolucency > 5mm |
|
| Talus: cystic radiolucency Progessive |
|
| Tibia: cystic radiolucency Progessive |
|
| Tibia Subsidence >5 |
|
| Talus Subsidence >5 |
|
| Title | Measurements |
|---|---|
|
| Total Activities of Daily Living Score |
|
| Total Sport/Recreation Score |
|
| Total QOL Score |
|
| Poor |
|