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Completed

NCT Number: NCT01285011

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

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.

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Key information

Conditions

Hammer Toe Ankylosis Claw Toe Foot Deformities Hammer Toe Syndrome Joint Diseases Musculoskeletal Diseases Revision of Arthrodesis or Arthroplasty Failure Shortening 2nd Toe

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sint Lucas Clinic, Bruges, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any patient who needs a proximal interphalangeal joint arthrodesis for whose surgeon has recommended that a proximal Interphalangeal Implant Ipp-On be implanted
  • Age >= 18 years
  • Have willingness to give his/her Data Transfer Authorization

Exclusion criteria

  • Contraindication of the implantation of the Ipp-On The implant should not be used in a patient who has currently, or who has a history of: • Active local or systemic infection
  • Severe peripheral vascular disease
  • Severe longitudinal deformity
  • Insufficient quantity or quality of bone to permit stabilization of the arthrodesis
  • Conditions that restrict the patient's ability or willingness to follow postoperative instructions during the healing process
  • Suspected or documented metal allergy or intolerance.
  • History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol

Treatment and study plan

Primary outcomes

  1. Rate of device related complications

    Time frame: 12 months

  2. fusion rate

    Time frame: 6 months

Secondary outcomes

  1. Fusion rate

    Time frame: 3 months

  2. American Orthopaedic Foot and Ankle Society Lesser Metatarsophalangeal Scale (AOFAS LMIS) score

    Time frame: 6 months/12 months

  3. Radiological Evaluation

    Time frame: 6 months/12 months

  4. Clinical Assessment

    Time frame: 6 months/12 months

  5. Subjective assessment

    Time frame: 6 months/12 months

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Services

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 27, 2011
Registry last updated
Sep 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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