SeriACL™ Device Trial for Anterior Cruciate Ligament (ACL) Reconstruction - Full Text View

Sponsored by:	Serica Technologies, Inc.
Information provided by:	Serica Technologies, Inc.
ClinicalTrials.gov Identifier:	NCT00490594

Purpose

The SeriACL device was developed as an alternative to an autograft (i.e., tissue that is taken from a patient's own body) or an allograft (i.e., tissue that is taken from a cadaver) for ACL reconstruction. The SeriACL device is made of silk yarns, knit and processed with SeriCoat™ surface treatment which makes it easier to wet the material. The SeriACL device is designed to be a temporary support structure to replace the torn ACL and to stabilize the knee joint following surgical repair. It is designed to use the body's own healing process to regenerate the patient's own new ligament tissue. As the new tissue grows and the support structure is needed less over time, the SeriACL device is bioresorbed (i.e., broken down) by the patient's body.

The SeriACL device is designed to be installed with standard surgical techniques for ACL repair.

This study is designed to test the safety of the SeriACL device in primary total ACL repair in patients with a torn ACL. The study will evaluate whether repair of the ACL with the SeriACL device will return the knee to normal function and what, if any, side effects will occur.

Condition	Intervention	Phase
Anterior Cruciate Ligament Knee Injuries	Device: ACL Reconstruction (SeriACL™ Device)	Phase I

MedlinePlus related topics: Knee Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment
Official Title:	A Multi-Center Open Study to Evaluate the SeriACL™ Device for Primary Anterior Cruciate Ligament Repair

Further study details as provided by Serica Technologies, Inc.:

Primary Outcome Measures:

Safety - measured by device related SAEs [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
KT-1000 Arthrometer [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Knee Surveys [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Return to Work [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	June 2007
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Bioresorbable ACL

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Complete ACL rupture
Injured knee range of motion >= 75% of contralateral knee
MCL tear grading <= 2
Sign informed consent.

Exclusion criteria:

Prior ACL reconstruction
Complete PCL tear
Locked bucket handle tear or complex tears of the menisci.
Contralateral knee ligament injury
Known joint disease
Known allergy to silk
Active drug or alcohol abuse
Pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490594

Locations

Germany
Atos Clinic
Heidelberg, Germany
Heidelberg University
Heidelberg, Germany
Norway
Ullevaal Hospital
Oslo, Norway

Sponsors and Collaborators

Serica Technologies, Inc.

Investigators

Principal Investigator:	Lars Engebretsen, MD	Ullevaal Hospital
Principal Investigator:	Hans Paessler, MD	ATOS Clinic, Heidelberg
Principal Investigator:	Holger Schmitt, MD	Heidelberg University

More Information

No publications provided

Responsible Party:	Serica Technologies, Inc. ( Rebecca Horan )
Study ID Numbers:	CLN-ACL1
Study First Received:	June 20, 2007
Last Updated:	October 17, 2008
ClinicalTrials.gov Identifier:	NCT00490594 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by Serica Technologies, Inc.:

ACL
ligament
ACL injury

Study placed in the following topic categories:

Wounds and Injuries
Disorders of Environmental Origin
Knee Injuries
Leg Injuries

Additional relevant MeSH terms:

Wounds and Injuries
Disorders of Environmental Origin
Knee Injuries
Leg Injuries

ClinicalTrials.gov processed this record on May 07, 2009