INBONE™ Total Ankle Prosthesis With Long Talar Stem

Arthritis Clinical Trial

Official title:

Limited Enrollment of the INBONE™ Total Ankle Prosthesis With Long Talar Stem

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01641848
• Other study ID #: 09-SJA-002
• Status: Terminated
• Phase: N/A
• First received: June 3, 2011
• Last updated: May 6, 2014
• Start date: December 2010
• Est. completion date: December 2012

Study information

• Verified date: August 2013
• Source: Wright Medical Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Infection of Total Ankle Joint Prosthesis

Intervention

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

Locations

Country	Name	City	State
United States	Orthopaedic Foot and Ankle Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Wright Medical Technology	Orthopedic Foot and Ankle Center, Ohio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	to measure change from pre-op to post-op at intervals up to 24 months postoperatively.	Yes