Osteoarthritis of Ankle, Rheumatoid Arthritis of Ankle, Traumatic Arthritis of Ankle
Conditions
Keywords
ankle, arthritis, total ankle arthroplasty, Agility LP,
Brief summary
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.
Interventions
None listed
Sponsors
Orthopaedic Associates of Michigan, PC
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Over 18 years old * Can comprehend and sign the informed consent * Patient must have undergone Agility LP ankle replacement between January 2006 to June 2008
Exclusion criteria
* Patient has had following procedures on the study limb within two years of TAA * Revision of TAA * Ankle arthrodesis * Amputation * Agility LP arthroplasty was done as a revision procedure for a failed TAA or as a takedown of ankle fusion. * Any condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Functional Outcomes Following Agility LP Ankle Replacement | A Minimum of 2 Years Post Index Procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Complication and Reoperation Rates | A Minimum of 2 Years Post Index Procedure | Number of reported complications/reoperations following the index procedure. |
| Radiographic Predictors of Implant Failures and Poor Outcomes | A Minimum of 2 Years Post Index Procedure | 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. |
Countries
United States
Participant flow
Recruitment details
Orthopaedic clinical, Agility LP TAA
Pre-assignment details
Minimum of 2 years post index procedure
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Agility LP Total Ankle Arthroplasty |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 27 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age Continuous | 62.1 years STANDARD_DEVIATION 4.36 |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 50 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: A Minimum of 2 Years Post Index Procedure
Population: Per surgical history (protocol).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Agility LP Total Ankle Arthroplasty | Assessment of Functional Outcomes Following Agility LP Ankle Replacement | Pre-operative range of motion | 37.67 Degrees | Standard Deviation 2.516 |
| Agility LP Total Ankle Arthroplasty | Assessment of Functional Outcomes Following Agility LP Ankle Replacement | Post-operative range of motion | 37.07 Degrees | Standard Deviation 2.511 |
Secondary
Evaluation of Complication and Reoperation Rates
Number of reported complications/reoperations following the index procedure.
Time frame: A Minimum of 2 Years Post Index Procedure
Population: Per Protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Agility LP Total Ankle Arthroplasty | Evaluation of Complication and Reoperation Rates | Wound Complication | 5 participants |
| Agility LP Total Ankle Arthroplasty | Evaluation of Complication and Reoperation Rates | Hardware Complication/Removal | 6 participants |
| Agility LP Total Ankle Arthroplasty | Evaluation of Complication and Reoperation Rates | Revisions and Takedowns | 3 participants |
| Agility LP Total Ankle Arthroplasty | Evaluation of Complication and Reoperation Rates | Other Surgical Intervention Related | 10 participants |
| Agility LP Total Ankle Arthroplasty | Evaluation of Complication and Reoperation Rates | Other Surgical Intervention Not Related | 3 participants |
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.
Time frame: A Minimum of 2 Years Post Index Procedure
Population: Per protocol, patients who were completely revised were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Agility LP Total Ankle Arthroplasty | Radiographic Predictors of Implant Failures and Poor Outcomes | Talar & Tibial Subsidence | 5 participants |
| Agility LP Total Ankle Arthroplasty | Radiographic Predictors of Implant Failures and Poor Outcomes | Talar Subsidence | 10 participants |
| Agility LP Total Ankle Arthroplasty | Radiographic Predictors of Implant Failures and Poor Outcomes | Tibial Subsidence | 1 participants |
| Agility LP Total Ankle Arthroplasty | Radiographic Predictors of Implant Failures and Poor Outcomes | Ingrowth of Both Components | 32 participants |