Claw Toe Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 156 |
Est. completion date | July 2012 |
Est. primary completion date | May 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Belgium | Sint Lucas Clinic | Brugge | |
France | CHU Pellegrin | Bordeaux | |
France | Clinique du Parc | Lyon | |
France | ICP | Paris | |
Switzerland | Ospedale Regionale di Bellinzona e Valli | Bellinzona |
Lead Sponsor | Collaborator |
---|---|
Integra LifeSciences Services |
Belgium, France, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of device related complications | 12 months | Yes | |
Primary | fusion rate | 6 months | No | |
Secondary | Fusion rate | 3 months | No | |
Secondary | American Orthopaedic Foot and Ankle Society Lesser Metatarsophalangeal Scale (AOFAS LMIS) score | 6 months/12 months | No | |
Secondary | Radiological Evaluation | 6 months/12 months | No | |
Secondary | Clinical Assessment | 6 months/12 months | No | |
Secondary | Subjective assessment | 6 months/12 months | No |
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---|---|---|---|
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