Follow-up of Patient Implanted With the Staple ASTUS®

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Services
ClinicalTrials.gov Identifier:
NCT01518543
First received: June 20, 2011
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

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.


Condition
Arthrodesis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Follow-up of Patient Implanted With the Staple ASTUS®

Further study details as provided by Integra LifeSciences Services:

Primary Outcome Measures:
  • Rate of healing at 3 month [ Time Frame: 3 month post implantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications rate [ Time Frame: 12 month follow-up ] [ Designated as safety issue: Yes ]
    Number of patients with an adverse event related to the device

  • Length of the surgery [ Time Frame: The time is the day of the surgery, the day the implantation of the device is done ] [ Designated as safety issue: No ]
    We collect the information of the length of the surgery for the implantation of the Astus Device


Enrollment: 5
Study Start Date: April 2010
Estimated Study Completion Date: January 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01518543

Locations
Ireland
Cappagh National Orthopaedic Hospital
Dublin, Ireland, 11
United Kingdom
Clatterbridge General Hospital
Wirral, United Kingdom
Sponsors and Collaborators
Integra LifeSciences Services
  More Information

No publications provided

Responsible Party: Integra LifeSciences Services
ClinicalTrials.gov Identifier: NCT01518543     History of Changes
Other Study ID Numbers: RECON-EMEA-04
Study First Received: June 20, 2011
Last Updated: October 9, 2012
Health Authority: Ireland: Medical Ethics Research Committee
Spain: Comité Ético de Investigación Clínica
Netherlands: Medical Ethics Review Committee (METC)
Germany: Ethics Commission
France: Institutional Ethical Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Integra LifeSciences Services:
arthrodesis
arthrodesis in the following joints:Ankle, 1st MTP, Metatarso - Cuneiform (1st), Navicular - Cuneiform, Talo-Navicular, Calcaneum - Cuboid;

ClinicalTrials.gov processed this record on August 19, 2014