Clinical trial NCT01641848: INBONE™ Total Ankle Prosthesis With Long Talar Stem
Official title: Limited Enrollment of the INBONE™ Total Ankle Prosthesis With Long Talar Stem
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthritis
Infection of Total Ankle Joint Prosthesis
Keywords: Total Ankle Arthroplasty
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
Collaborators: name: Orthopedic Foot and Ankle Center, Ohio
First posted: 2012-07-17
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Subject has sufficient soft tissue and muscle strength to support stable, anatomic positioning and motion of arthroplasty components as determined by the investigator
2. Subject must have sufficient skin for wound coverage.
3. 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:

1. end stage arthritis as determined by the investigator on plain radiographs
2. pain during physical examination of the tibio-talar joint
3. fusion
4. non-union
5. 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:

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

Primary outcomes:
measure: to measure the subject's pain, disability and activity level restrictions within the last week.
timeFrame: to measure change from pre-op (baseline) at specified intervals up to 24 months post-op
Secondary outcomes:
measure: Radiographic Evaluation
timeFrame: to measure change from pre-op to post-op at intervals up to 24 months postoperatively.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Orthopaedic Foot and Ankle Center
state: Ohio
Study officials:
affiliation: Orthopedic Foot and Ankle Center
name: Thomas Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: