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This is a research study which is being done to determine the outcomes following Agility LP ankle replacement. This implant was approved by the FDA in 2007 and has been used since then with good early results. You are being asked to volunteer for this study because you have undergone Total Ankle Arthroplasty with Agility LP prosthesis. The purpose of the study is to compare the range of motion, level of pain and function during daily living prior to and after your ankle surgery.
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| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Functional Outcomes Following Agility LP Ankle Replacement | Range of Motion - Combined total of dorsiflexion and plantarflexion. Full range of motion is described as 30 degrees or more. Partial limitation is described as 29 to 15 degrees. Range of motion that is less than 15 degrees is described as severely limited. | A Minimum of 2 Years Post Index Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Complication and Reoperation Rates | Number of reported complications/reoperations following the index procedure. | A Minimum of 2 Years Post Index Procedure |
| Radiographic Predictors of Implant Failures and Poor Outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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Female and male subjects over the age of 18 at the time of procedure who have undergone ankle joint replacement using the DePuy Agility LP Device.
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| Name | Affiliation | Role |
|---|---|---|
| John G Anderson, MD | Orthopaedic Associates of Michigan, PC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Associates of Michigan, PC | Grand Rapids | Michigan | 49525 | United States |
Minimum of 2 years post index procedure
Orthopaedic clinical, Agility LP TAA
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| ID | Title | Description |
|---|---|---|
| FG000 | Agility LP Total Ankle Arthroplasty | Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Agility LP Total Ankle Arthroplasty | Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Assessment of Functional Outcomes Following Agility LP Ankle Replacement | Range of Motion - Combined total of dorsiflexion and plantarflexion. Full range of motion is described as 30 degrees or more. Partial limitation is described as 29 to 15 degrees. Range of motion that is less than 15 degrees is described as severely limited. | Per surgical history (protocol). | Posted | Mean | Standard Deviation | Degrees | A Minimum of 2 Years Post Index Procedure |
|
|
Minimum of 2 years post index procedure
Self reported by patient, medical record review
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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 | Agility LP Total Ankle Arthroplasty | Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hardware Complication | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Painful hardware which required post-surgical removal |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John G. Anderson | Orthopaedic Associates of Michigan, PC | 616-459-7101 | 797 | John.Anderson@oamichigan.com |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Post-Operative radiographic disposition. Subsidence is described as the component sinking into the bone. Ingrowth is described as the implant components to conform into the tibia and talus.
| A Minimum of 2 Years Post Index Procedure |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
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| Secondary | Evaluation of Complication and Reoperation Rates | Number of reported complications/reoperations following the index procedure. | Per Protocol | Posted | Number | participants | A Minimum of 2 Years Post Index Procedure |
|
|
|
| Secondary | Radiographic Predictors of Implant Failures and Poor Outcomes | Post-Operative radiographic disposition. Subsidence is described as the component sinking into the bone. Ingrowth is described as the implant components to conform into the tibia and talus. | Per protocol, patients who were completely revised were excluded. | Posted | Number | participants | A Minimum of 2 Years Post Index Procedure |
|
|
|
| 0 |
| 0 |
| 14 |
| 50 |
|
| Wound Complication | Infections and infestations | Non-systematic Assessment | Patient who required wound care beyond the accepted standard of care for resolution. |
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| Surgical Revision of Implant | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patients who had their initial implant revised or removed. |
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| Other Surgical Intervention Related to Index Procedure | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Patient required surgical intervention |
|
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| Title |
|---|
| Measurements |
|---|
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| Other Surgical Intervention Related |
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| Other Surgical Intervention Not Related |
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| Title | Measurements |
|---|---|
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| Ingrowth of Both Components |
|