Rheumatoid Arthritis of Ankle Clinical Trial
Official title:
Agility LP Ankle Arthroplasty: Clinical and Radiographic Outcomes
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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | September 2012 |
| Est. primary completion date | August 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Case-Only, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| United States | Orthopaedic Associates of Michigan, PC | Grand Rapids | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Orthopaedic Associates of Michigan, PC |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | A Minimum of 2 Years Post Index Procedure | No |
| Secondary | Evaluation of Complication and Reoperation Rates | Number of reported complications/reoperations following the index procedure. | A Minimum of 2 Years Post Index Procedure | No |
| 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. | A Minimum of 2 Years Post Index Procedure | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
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