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
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.
|Condition or disease|
|Hammer Toe Claw Toe Shortening 2nd Toe Revision of Arthrodesis or Arthroplasty Failure|
|Study Type :||Observational|
|Actual Enrollment :||156 participants|
|Official Title:||Short Term Follow-up of Patient Implanted With the Proximal Interphalangeal|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||July 2012|
Patient implanted with the Ipp-On
- Rate of device related complications [ Time Frame: 12 months ]
- fusion rate [ Time Frame: 6 months ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01285011
|Sint Lucas Clinic|
|Clinique du Parc|
|Ospedale Regionale di Bellinzona e Valli|