INBONE™ Total Ankle Prosthesis With Long Talar Stem

NCT ID: NCT01641848

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-12-31

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.

Conditions

Arthritis; Infection of Total Ankle Joint Prosthesis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arthritic and injured ankles

InBone TAA

Group Type: EXPERIMENTAL

INBONE™ Total Ankle Prosthesis with Long Talar Stem

Intervention Type: DEVICE

INBONE™ Total Ankle Prosthesis with Long Talar Stem when used with a Calcaneal Stem

Interventions

INBONE™ Total Ankle Prosthesis with Long Talar Stem

INBONE™ Total Ankle Prosthesis with Long Talar Stem when used with a Calcaneal Stem

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orthopedic Foot and Ankle Center, Ohio

OTHER

Sponsor Role: collaborator

Stryker Trauma and Extremities

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Orthopedic Foot and Ankle Center

Locations

Orthopaedic Foot and Ankle Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

09-SJA-002

Identifier Type: -

Identifier Source: org_study_id