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

Integra LifeSciences

Status: Completed

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01285011

RECON-EMEA-08

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

156 participants in 1 patient group

Ipp-On

Description:

Patient implanted with the Ipp-On