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

Completed

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

• Registration Number: NCT01285011
• Lead Sponsor: Integra LifeSciences Services

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 Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2011-01-26
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Primary Completion: 2012-05
• Study Completion: 2012-07
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-10
• Last Update Posted: 2014-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of device related complications	12 months
fusion rate	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Sint Lucas Clinic; 🇧🇪 Brugge, Belgium

CHU Pellegrin; 🇫🇷 Bordeaux, France

Clinique du Parc; 🇫🇷 Lyon, France

ICP; 🇫🇷 Paris, France

Ospedale Regionale di Bellinzona e Valli; 🇨🇭 Bellinzona, Switzerland