Follow-up of Patient Implanted With the Staple ASTUS®

NCT01518543 | Terminated

• 1 other identifier: RECON-EMEA-04
• Study Type: observational
• Target: 5
• Locations: 2 countries
• Sites: 2

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.

Conditions

Arthrodesis

Keywords

arthrodesis; arthrodesis in the following joints:Ankle, 1st MTP, Metatarso - Cuneiform (1st), Navicular - Cuneiform, Talo-Navicular, Calcaneum - Cuboid;

Outcome Measures

Primary Outcomes (1)

• Rate of healing at 3 month

  3 month post implantation

Secondary Outcomes (2)

• Complications rate

  12 month follow-up

• Length of the surgery

  The time is the day of the surgery, the day the implantation of the device is done

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Integra LifeSciences Services: lead

Study Sites (2)

Cappagh National Orthopaedic Hospital

Dublin, 11, Ireland

Location

Clatterbridge General Hospital

Metropolitan Borough of Wirral, United Kingdom

Location

MeSH Terms

Conditions

Ankylosis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2011
• First Posted: January 26, 2012
• Study Start: April 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2013
• Last Updated: September 11, 2014

Record last verified: 2014-09

Locations

IE (1); GB (1)