Status:
TERMINATED
Follow-up of Patient Implanted With the Staple ASTUS®
Lead Sponsor:
Integra LifeSciences Services
Conditions:
Arthrodesis
Eligibility:
All Genders
18+ years
Brief Summary
There are many ways of performing arthrodesis in the foot and ankle. Dowel fusion is one of them. The in situ technique was first described by Ottolenghi et al. (1970) and was taken up by Baciu and F...
Eligibility Criteria
Inclusion
- Age ≥ 18 years;
- Have willingness to give his/her data transfer authorisation;
- Patient candidate for an arthrodesis in the following joints (Ankle, 1st MTP, Metatarso - Cuneiform (1st), Navicular - Cuneiform, Talo-Navicular, calcaneum - Cuboid) and whose surgeon has recommended the implantation of an ASTUS Staple from Newdeal-INTEGRA.
Exclusion
- Patient candidate for an arthrodesis not listed in the inclusion criteria (as Subtalar arthrodesis and Metatarso-cuboid arthrodesis) will not be included in this study;
- Patient re-operated due to a previous failed of fusion of the same joint will not be also included;
- Patients will be excluded from the study if they have an history of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01518543
Start Date
April 1 2010
End Date
January 1 2013
Last Update
September 11 2014
Active Locations (2)
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1
Cappagh National Orthopaedic Hospital
Dublin, Ireland, 11
2
Clatterbridge General Hospital
Metropolitan Borough of Wirral, United Kingdom