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INBONE™ Total Ankle Prosthesis With Long Talar Stem

Primary Purpose

Arthritis, Infection of Total Ankle Joint Prosthesis

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

INBONE™ Total Ankle Prosthesis with Long Talar Stem

About this trial

This is an interventional treatment trial for Arthritis focused on measuring Total Ankle Arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Orthopaedic Foot and Ankle Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arthritic and injured ankles

Arm Description

InBone TAA

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01641848

First Posted

June 3, 2011

Last Updated

May 6, 2014

Sponsor

Stryker Trauma GmbH

Collaborators

Orthopedic Foot and Ankle Center, Ohio

1. Study Identification

Unique Protocol Identification Number

NCT01641848

Brief Title

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

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Terminated

Why Stopped

Lack of patient enrollment

Study Start Date

December 2010 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stryker Trauma GmbH

Collaborators

Orthopedic Foot and Ankle Center, Ohio

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis, Infection of Total Ankle Joint Prosthesis

Keywords

Total Ankle Arthroplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arthritic and injured ankles

Arm Type

Experimental

Arm Description

InBone TAA

Intervention Type

Device

Intervention Name(s)

INBONE™ Total Ankle Prosthesis with Long Talar Stem

Intervention Description

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

Primary Outcome Measure Information:

Title

to measure the subject's pain, disability and activity level restrictions within the last week.

Description

Time Frame

to measure change from pre-op (baseline) at specified intervals up to 24 months post-op

Secondary Outcome Measure Information:

Title

Radiographic Evaluation

Description

Time Frame

to measure change from pre-op to post-op at intervals up to 24 months postoperatively.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Lee, M.D.

Organizational Affiliation

Orthopedic Foot and Ankle Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Orthopaedic Foot and Ankle Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43082

Country

United States

12. IPD Sharing Statement

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INBONE™ Total Ankle Prosthesis With Long Talar Stem

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