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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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.


Detailed Summary:
Sponsor: Integra LifeSciences Services

Current Primary Outcome:

  • Rate of device related complications [ Time Frame: 12 months ]
  • fusion rate [ Time Frame: 6 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Fusion rate [ Time Frame: 3 months ]
  • American Orthopaedic Foot and Ankle Society Lesser Metatarsophalangeal Scale (AOFAS LMIS) score [ Time Frame: 6 months/12 months ]
  • Radiological Evaluation [ Time Frame: 6 months/12 months ]
  • Clinical Assessment [ Time Frame: 6 months/12 months ]
  • Subjective assessment [ Time Frame: 6 months/12 months ]


Original Secondary Outcome: Same as current

Information By: Integra LifeSciences Services

Dates:
Date Received: January 26, 2011
Date Started: April 2009
Date Completion:
Last Updated: September 10, 2014
Last Verified: September 2014