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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01285011
Other study ID # RECON-EMEA-08
Secondary ID
Status Completed
Phase N/A
First received January 26, 2011
Last updated September 10, 2014
Start date April 2009
Est. completion date July 2012

Study information

Verified date September 2014
Source Integra LifeSciences Services
Contact n/a
Is FDA regulated No
Health authority France: Institutional Ethical CommitteeBelgium: Institutional Review BoardSwitzerland: Ethikkommission
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Integra LifeSciences Services

Countries where clinical trial is conducted

Belgium,  France,  Switzerland, 

Outcome

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
See also
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Completed NCT04154046 - Treatment of Impending Ulcers Associated With Hammer, Mallet and Claw Toe Deformities in the Diabetic Patient Setting N/A
Completed NCT04610437 - Intramedullary Resorbable Fixation System Versus K-wire for the Treatment of Lesser Toe Deformities N/A