Clinical trial NCT01285011: Short Term Follow-up of Patient Implanted With the Proximal Interphalangeal Implant
Official title: Short Term Follow-up of Patient Implanted With the Proximal Interphalangeal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hammer Toe
Claw Toe
Shortening 2nd Toe
Revision of Arthrodesis or Arthroplasty Failure
Keywords: arthrodesis
PIP joint
Lead sponsor: Integra LifeSciences Services
Sponsor class: INDUSTRY
First posted: 2011-01-27
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Rate of device related complications
timeFrame: 12 months
measure: fusion rate
timeFrame: 6 months
Secondary outcomes:
measure: Fusion rate
timeFrame: 3 months
measure: American Orthopaedic Foot and Ankle Society Lesser Metatarsophalangeal Scale (AOFAS LMIS) score
timeFrame: 6 months/12 months
measure: Radiological Evaluation
timeFrame: 6 months/12 months
measure: Clinical Assessment
timeFrame: 6 months/12 months
measure: Subjective assessment
timeFrame: 6 months/12 months
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Sint Lucas Clinic
city: Bordeaux
country: France
facility: CHU Pellegrin
city: Lyon
country: France
facility: Clinique du Parc
city: Paris
country: France
facility: ICP
city: Bellinzona
country: Switzerland
facility: Ospedale Regionale di Bellinzona e Valli
Study officials:
References: