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

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 156

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium
    • Sint Lucas Clinic
• France
  • Bordeaux, France
    • CHU Pellegrin
  • Lyon, France
    • Clinique du parc
  • Paris, France
    • ICP
• Switzerland
  • Bellinzona, Switzerland
    • Ospedale Regionale di Bellinzona e Valli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient who needs a proximal interphalangeal joint arthrodesis for whose surgeon has recommended that a proximal Interphalangeal Implant Ipp-On be implanted

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Ipp-On; Patient implanted with the Ipp-On

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of device related complications	12 months
fusion rate	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Clinical Assessment	6 months/12 months
Subjective assessment	6 months/12 months

Collaborators and Investigators

• Sponsor: Integra LifeSciences Services

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: January 26, 2011
• First Submitted That Met QC Criteria: January 26, 2011
• First Posted (Estimate): January 27, 2011

Study Record Updates

• Last Update Posted (Estimate): September 11, 2014
• Last Update Submitted That Met QC Criteria: September 10, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: PIP joint; arthrodesis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Hammer Toe Syndrome
• Other Study ID Numbers: RECON-EMEA-08