INBONE™ Total Ankle Prosthesis With Long Talar Stem

Not Applicable

Terminated

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Subject has sufficient soft tissue and muscle strength to support stable, anatomic positioning and motion of arthroplasty components as determined by the investigator
Subject must have sufficient skin for wound coverage.
Subject demonstrates subtalar joint insufficiency as defined by any of the following:

(1)range of motion <50 percent of the contralateral, non-diseased side (2)pain during physical examination of the subtalar joint (3)fusion

AND

Subject demonstrates tibio-talar joint insufficiency as defined by any of the following:

end stage arthritis as determined by the investigator on plain radiographs
pain during physical examination of the tibio-talar joint
fusion
non-union
failed Total Ankle Replacement 4.Subject has Body Mass Index (BMI) < 40 5.Subject has sufficient calcaneal bone stock as determined by the investigator 6.Subject is able to or capable of providing consent to participate in the clinical investigation and has medical insurance to cover costs associated with their medical care or is willing to assume personal responsibility for costs 7.Subject agrees to comply with this protocol, including participating in required follow-up visits at the investigations site and completing study questionnaires

Exclusion Criteria

Subject is skeletally immature and under 21 years of age
Subject has experienced local or systemic infection within the past twelve months
Subject has symptomatic ankle disease or has been treated operatively on the contralateral side
Subject has vascular and kidney insufficiencies
Subject is suspected to have neuropathy of the foot or ankle
Subject has impaired vascular circulation in the affected limb
Subject has skin condition that may impair wound healing
Subject has known allergy to cobalt, chromium, molybdenum, titanium, aluminum, vanadium, or nickel
Subjects on long term medications which may compromise bone stock (e.g. long term steroids, NSAIDS, etc., physicians discretion
Subject is unwilling or unable to comply with a rehabilitation program
Subject is known to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser
Subject is currently participating in any investigational study not related to this study's preoperative and postoperative care.
Subject has rheumatoid arthritis (RA)
Subject has been diagnosed with osteoporosis as defined as a DXA t-score >-2.5.

Arm && Interventions

Group	Intervention	Description
Arthritic and injured ankles	INBONE™ Total Ankle Prosthesis with Long Talar Stem	InBone TAA

Primary Outcome Measures

Name	Time	Method
to measure the subject's pain, disability and activity level restrictions within the last week.	to measure change from pre-op (baseline) at specified intervals up to 24 months post-op	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.

Secondary Outcome Measures

Name	Time	Method
Radiographic Evaluation	to measure change from pre-op to post-op at intervals up to 24 months postoperatively.	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.