Follow-up of Patient Implanted With the Staple ASTUS®

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.

Study Overview

• Status: Terminated
• Conditions: Arthrodesis

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, 11
    • Cappagh National Orthopaedic Hospital
• United Kingdom
  • Wirral, United Kingdom
    • Clatterbridge General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
ASTUS; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of healing at 3 month	3 month post implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications rate	Number of patients with an adverse event related to the device	12 month follow-up
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

Collaborators and Investigators

• Sponsor: Integra LifeSciences Services

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: June 20, 2011
• First Submitted That Met QC Criteria: January 25, 2012
• First Posted (Estimate): January 26, 2012

Study Record Updates

• Last Update Posted (Estimate): September 11, 2014
• Last Update Submitted That Met QC Criteria: September 10, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: arthrodesis; arthrodesis in the following joints:Ankle, 1st MTP, Metatarso - Cuneiform (1st), Navicular - Cuneiform, Talo-Navicular, Calcaneum - Cuboid
• Other Study ID Numbers: RECON-EMEA-04