INBONE™ Total Ankle Prosthesis With Long Talar Stem

NCT01641848 | Terminated DMC

• 1 other identifier: 09-SJA-002
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis; Infection of Total Ankle Joint Prosthesis

Keywords

Total Ankle Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• Radiographic Evaluation

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

Study Arms (1)

Arthritic and injured ankles

EXPERIMENTAL

InBone TAA

Device: INBONE™ Total Ankle Prosthesis with Long Talar Stem

Interventions

INBONE™ Total Ankle Prosthesis with Long Talar Stem DEVICE

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

Arthritic and injured ankles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stryker Trauma and Extremities: lead
• Orthopedic Foot and Ankle Center, Ohio: collaborator

Study Sites (1)

Orthopaedic Foot and Ankle Center

Columbus, Ohio, 43082, United States

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Thomas Lee, M.D.

  Orthopedic Foot and Ankle Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2011
• First Posted: July 17, 2012
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 22, 2014

Record last verified: 2013-08

Locations

US (1)