Ignite Creation Date:
2024-05-05 @ 11:13 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01285011
Status:
COMPLETED
Last Update Posted:
2014-09-11
First Post:
2011-01-26
Brief Title:
Short Term Follow-up of Patient Implanted With the Proximal Interphalangeal Implant
Sponsor:
Integra LifeSciences Services
Organization:
Integra LifeSciences Services
Study Overview
Official Title:
Short Term Follow-up of Patient Implanted With the Proximal Interphalangeal
Status:
COMPLETED
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hammertoe and ClawToe are ones of the most common foot deformities The second toe is the most frequently affected but the other small toes may also be involved When nonoperative treatment fails surgery often is recommended One surgical option is the arthrodesis of the Proximal Interphalangeal PIP joint This arthrodesis is technically demanding its needs
Internal fixation
Interphalangeal Compression
Anatomic PIP joint plantar flexion angle The implant Ipp-On has been developed for this specific arthrodesis The objective of this study is to evaluate the efficacy and safety of the Proximal Interphalangeal Implant Ipp-On at short term follow up
The safety of the Ipp-On will be described in terms of rate of device related complications
The efficacy of the Ipp-On will be described in terms of fusion rate at 6 months
Internal fixation
Interphalangeal Compression
Anatomic PIP joint plantar flexion angle The implant Ipp-On has been developed for this specific arthrodesis The objective of this study is to evaluate the efficacy and safety of the Proximal Interphalangeal Implant Ipp-On at short term follow up
The safety of the Ipp-On will be described in terms of rate of device related complications
The efficacy of the Ipp-On will be described in terms of fusion rate at 6 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None