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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Services
ClinicalTrials.gov Identifier:
NCT01285011
First received: January 26, 2011
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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.


Condition
Hammer Toe
Claw Toe
Shortening 2nd Toe
Revision of Arthrodesis or Arthroplasty Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Short Term Follow-up of Patient Implanted With the Proximal Interphalangeal

Further study details as provided by Integra LifeSciences Services:

Primary Outcome Measures:
  • Rate of device related complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • fusion rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fusion rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • American Orthopaedic Foot and Ankle Society Lesser Metatarsophalangeal Scale (AOFAS LMIS) score [ Time Frame: 6 months/12 months ] [ Designated as safety issue: No ]
  • Radiological Evaluation [ Time Frame: 6 months/12 months ] [ Designated as safety issue: No ]
  • Clinical Assessment [ Time Frame: 6 months/12 months ] [ Designated as safety issue: No ]
  • Subjective assessment [ Time Frame: 6 months/12 months ] [ Designated as safety issue: No ]

Enrollment: 156
Study Start Date: April 2009
Study Completion Date: July 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Ipp-On
Patient implanted with the Ipp-On

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01285011

Locations
Belgium
Sint Lucas Clinic
Brugge, Belgium
France
CHU Pellegrin
Bordeaux, France
Clinique du Parc
Lyon, France
ICP
Paris, France
Switzerland
Ospedale Regionale di Bellinzona e Valli
Bellinzona, Switzerland
Sponsors and Collaborators
Integra LifeSciences Services
  More Information

No publications provided

Responsible Party: Integra LifeSciences Services
ClinicalTrials.gov Identifier: NCT01285011     History of Changes
Other Study ID Numbers: RECON-EMEA-08
Study First Received: January 26, 2011
Last Updated: September 10, 2014
Health Authority: France: Institutional Ethical Committee
Belgium: Institutional Review Board
Switzerland: Ethikkommission

Keywords provided by Integra LifeSciences Services:
arthrodesis
PIP joint

ClinicalTrials.gov processed this record on October 20, 2014