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

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ClinicalTrials.gov Identifier: NCT01285011
Recruitment Status : Completed
First Posted : January 27, 2011
Last Update Posted : September 11, 2014
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Services

January 26, 2011
January 27, 2011
September 11, 2014
April 2009
May 2012   (Final data collection date for primary outcome measure)
  • Rate of device related complications [ Time Frame: 12 months ]
  • fusion rate [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT01285011 on ClinicalTrials.gov Archive Site
  • Fusion rate [ Time Frame: 3 months ]
  • American Orthopaedic Foot and Ankle Society Lesser Metatarsophalangeal Scale (AOFAS LMIS) score [ Time Frame: 6 months/12 months ]
  • Radiological Evaluation [ Time Frame: 6 months/12 months ]
  • Clinical Assessment [ Time Frame: 6 months/12 months ]
  • Subjective assessment [ Time Frame: 6 months/12 months ]
Same as current
Not Provided
Not Provided
 
Short Term Follow-up of Patient Implanted With the Proximal Interphalangeal Implant
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Any patient who needs a proximal interphalangeal joint arthrodesis for whose surgeon has recommended that a proximal Interphalangeal Implant Ipp-On be implanted
  • Hammer Toe
  • Claw Toe
  • Shortening 2nd Toe
  • Revision of Arthrodesis or Arthroplasty Failure
Not Provided
Ipp-On
Patient implanted with the Ipp-On
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
153
July 2012
May 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France,   Switzerland
 
 
NCT01285011
RECON-EMEA-08
No
Not Provided
Not Provided
Integra LifeSciences Services
Integra LifeSciences Services
Not Provided
Not Provided
Integra LifeSciences Services
September 2014