Clinical trial NCT01518543: Follow-up of Patient Implanted With the Staple ASTUS®
Official title: Follow-up of Patient Implanted With the Staple ASTUS®
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arthrodesis
Keywords: arthrodesis
arthrodesis in the following joints:Ankle, 1st MTP, Metatarso - Cuneiform (1st), Navicular - Cuneiform, Talo-Navicular, Calcaneum - Cuboid;
Lead sponsor: Integra LifeSciences Services
Sponsor class: INDUSTRY
First posted: 2012-01-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 can be enrolled in this study

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 Filibiu (1979). In the technique, they did take the dowel out before turning it. The healing process takes place between surfaces of spongious bone. They showed excellent results with early weight bearing and healing within 12.5 weeks. Stranks et al. (1994) combined the dowel technique with screw fixation and claimed 95 % healing rate within 12.5 weeks. Others have not found this technique satisfactory in rheumatoid arthritis patients (Belt et al. 2001). The results were not compatible to common fusion techniques. The reason may be the circular bone gap of at least 1 mm left by the saw blade.

A new instrumentation and a new staple with a central wedge (ASTUS) avoid this gap and allow the dowel to be turned in situ without leaving in position. The staple is introduced into the joint line and will compress the dowel surfaces against the surrounding bone. Instruments are available to ensure the correct position and length of the dowel, and to rotate it in situ before the special wedge staple is introduced.

Dr Kofoed, the surgeon designer of the ASTUS Staple, has communicated on his first series with 83 arthrodesis. The purpose of this study is now to collect and publish data from several centers, several users.

The objective of this study is to obtain the percentage of healing 3 months after an implantation of the staple ASTUS.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Rate of healing at 3 month
timeFrame: 3 month post implantation
Secondary outcomes:
measure: Complications rate
timeFrame: 12 month follow-up
measure: Length of the surgery
timeFrame: The time is the day of the surgery, the day the implantation of the device is done
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Cappagh National Orthopaedic Hospital
city: Wirral
country: United Kingdom
facility: Clatterbridge General Hospital
Study officials:
References: