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

NCT01285011 | Completed

• 1 other identifier: RECON-EMEA-08
• Study Type: observational
• Target: 156
• Locations: 3 countries
• Sites: 5

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.

Conditions

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

Keywords

arthrodesis; PIP joint

Outcome Measures

Primary Outcomes (2)

• Rate of device related complications

  12 months

• fusion rate

  6 months

Secondary Outcomes (5)

• Fusion rate

  3 months

• American Orthopaedic Foot and Ankle Society Lesser Metatarsophalangeal Scale (AOFAS LMIS) score

  6 months/12 months

• Radiological Evaluation

  6 months/12 months

• Clinical Assessment

  6 months/12 months

• Subjective assessment

  6 months/12 months

Study Arms (1)

Ipp-On

Patient implanted with the Ipp-On

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Integra LifeSciences Services: lead

Study Sites (5)

Sint Lucas Clinic

Bruges, Belgium

Location

CHU Pellegrin

Bordeaux, France

Location

Clinique du Parc

Lyon, France

Location

ICP

Paris, France

Location

Ospedale Regionale di Bellinzona e Valli

Bellinzona, Switzerland

Location

MeSH Terms

Conditions

Hammer Toe Syndrome; Ankylosis

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases; Joint Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2011
• First Posted: January 27, 2011
• Study Start: April 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 11, 2014

Record last verified: 2014-09

Locations

FR (3); BE (1); CH (1)