NCT01285011

Short Term Follow-up of Patient Implanted With the Proximal Interphalangeal Implant

Short Term Follow-up of Patient Implanted With the Proximal Interphalangeal

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 156 (actual)
• Sponsor: Integra LifeSciences Services · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hammer Toe
• Claw Toe
• Shortening 2nd Toe
• Revision of Arthrodesis or Arthroplasty Failure

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-05-01
• Completion: 2012-07-01
• First posted: 2011-01-27
• Last updated: 2014-09-11

Locations

5 sites across 3 countries: Belgium, France, Switzerland