The primary objective of this study is to collect preoperative, operative and postoperative clinical assessments of patients that qualify for surgical implantation of the INBONE™ Total Ankle Prosthesis.
The FDA approved the "limited enrollment" registry to provide us with additional clinical data from which to design a pivotal IDE study. FDA has stated that their decision for this was based upon "adequate safety information" which was submitted to them as part of the original IDE submission. Therefore, the purpose of this "limited enrollment" registry study is to gather initial data on the device's performance, when used with a Calcaneal Stem.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
INBONE™ Total Ankle Prosthesis with Long Talar Stem when used with a Calcaneal Stem
Orthopaedic Foot and Ankle Center
Columbus, Ohio, United States
to measure the subject's pain, disability and activity level restrictions within the last week.
The FFI, Foot Function Index is a validated self-administered scoring system designed to measure the subject's pain, disability and activity levels within the past week. Possible scores range from 0-100 with a lower score representing less pain, greater function and less restricted ambulation.
Time frame: to measure change from pre-op (baseline) at specified intervals up to 24 months post-op
Radiographic Evaluation
Standard AP and lateral and oblique x-rays will be obtained at pre-operatively, and at 6 weeks, 3, 6, 12 and 24 months postoperatively. Any standard of care image can be performed 30 days prior to consenting.
Time frame: to measure change from pre-op to post-op at intervals up to 24 months postoperatively.
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