N/A
N=50
Agility LP Ankle Arthroplasty Outcomes
Rheumatoid Arthritis of Ankle · Osteoarthritis of Ankle · Traumatic Arthritis of Ankle
Bottom Line
View on ClinicalTrials.gov: NCT01366872 ↗Enrolled (actual)
50
Serious AEs
—
Results posted
Dec 2012
Primary outcome: Primary: Assessment of Functional Outcomes Following Agility LP Ankle Replacement — 37.67; 37.07 Degrees
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Orthopaedic Associates of Michigan, PC
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Functional Outcomes Following Agility LP Ankle Replacement |
37.67; 37.07 | — |
| SECONDARY Evaluation of Complication and Reoperation Rates |
6; 5; 3; 10; 3 | — |
| SECONDARY Radiographic Predictors of Implant Failures and Poor Outcomes |
10; 1; 5; 32 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01366872). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.