Follow-up of Patient Implanted With the Staple ASTUS®

Arthrodesis Clinical Trial

Official title:

Follow-up of Patient Implanted With the Staple ASTUS®

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01518543
• Other study ID #: RECON-EMEA-04
• Status: Terminated
• Phase: N/A
• First received: June 20, 2011
• Last updated: September 10, 2014
• Start date: April 2010
• Est. completion date: January 2013

Study information

• Verified date: September 2014
• Source: Integra LifeSciences Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Medical Ethics Research CommitteeSpain: Comité Ético de Investigación ClínicaNetherlands: Medical Ethics Review Committee (METC)Germany: Ethics CommissionFrance: Institutional Ethical CommitteeFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthrodesis

Locations

Country	Name	City	State
Ireland	Cappagh National Orthopaedic Hospital	Dublin
United Kingdom	Clatterbridge General Hospital	Wirral

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Services

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of healing at 3 month		3 month post implantation	No
Secondary	Complications rate	Number of patients with an adverse event related to the device	12 month follow-up	Yes
Secondary	Length of the surgery	We collect the information of the length of the surgery for the implantation of the Astus Device	The time is the day of the surgery, the day the implantation of the device is done	No