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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01285011

Enrollment

156

Registered

2011-01-27

Start date

2009-04-30

Completion date

2012-07-31

Last updated

2014-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

arthrodesis, PIP joint

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Belgium, France, Switzerland

Outcome results