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

Claw Toe Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01285011
• Other study ID #: RECON-EMEA-08
• 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

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

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