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INBONE™ Total Ankle Prosthesis With Long Talar Stem

This study has been terminated.
(Lack of patient enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01641848
First Posted: July 17, 2012
Last Update Posted: May 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Orthopedic Foot and Ankle Center, Ohio
Information provided by (Responsible Party):
Wright Medical Technology
  Purpose
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.

Condition Intervention
Arthritis Infection of Total Ankle Joint Prosthesis Device: INBONE™ Total Ankle Prosthesis with Long Talar Stem

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Limited Enrollment of the INBONE™ Total Ankle Prosthesis With Long Talar Stem

Further study details as provided by Wright Medical Technology:

Primary Outcome Measures:
  • to measure the subject's pain, disability and activity level restrictions within the last week. [ Time Frame: 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:
  • Radiographic Evaluation [ Time Frame: 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.


Enrollment: 1
Study Start Date: December 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arthritic and injured ankles
InBone TAA
Device: INBONE™ Total Ankle Prosthesis with Long Talar Stem
INBONE™ Total Ankle Prosthesis with Long Talar Stem when used with a Calcaneal Stem

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01641848


Locations
United States, Ohio
Orthopaedic Foot and Ankle Center
Columbus, Ohio, United States, 43082
Sponsors and Collaborators
Wright Medical Technology
Orthopedic Foot and Ankle Center, Ohio
Investigators
Principal Investigator: Thomas Lee, M.D. Orthopedic Foot and Ankle Center
  More Information

Responsible Party: Wright Medical Technology
ClinicalTrials.gov Identifier: NCT01641848     History of Changes
Other Study ID Numbers: 09-SJA-002
First Submitted: June 3, 2011
First Posted: July 17, 2012
Last Update Posted: May 22, 2014
Last Verified: August 2013

Keywords provided by Wright Medical Technology:
Total Ankle Arthroplasty