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

NCT01285011 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 156

Last updated 2014-09-11

No results posted yet for this study

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

Sponsors & Collaborators

  • Integra LifeSciences Services

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2012-05-31
Completion
2012-07-31

Countries

  • Belgium
  • France
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01285011 on ClinicalTrials.gov