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SeriACL™ Device Trial for Anterior Cruciate Ligament (ACL) Reconstruction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00490594
Recruitment Status : Unknown
Verified October 2008 by Serica Technologies, Inc..
Recruitment status was:  Active, not recruiting
First Posted : June 22, 2007
Last Update Posted : October 20, 2008
Information provided by:
Serica Technologies, Inc.

Brief Summary:

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 or disease Intervention/treatment Phase
Anterior Cruciate Ligament Knee Injuries Device: ACL Reconstruction (SeriACL™ Device) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center Open Study to Evaluate the SeriACL™ Device for Primary Anterior Cruciate Ligament Repair
Study Start Date : June 2007
Estimated Primary Completion Date : October 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: ACL Reconstruction (SeriACL™ Device)
    Bioresorbable ACL

Primary Outcome Measures :
  1. Safety - measured by device related SAEs [ Time Frame: 12 months ]
  2. KT-1000 Arthrometer [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Knee Surveys [ Time Frame: 12 months ]
  2. Return to Work [ Time Frame: 12 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00490594

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Atos Clinic
Heidelberg, Germany
Heidelberg University
Heidelberg, Germany
Ullevaal Hospital
Oslo, Norway
Sponsors and Collaborators
Serica Technologies, Inc.
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Principal Investigator: Lars Engebretsen, MD Ullevaal Hospital
Principal Investigator: Hans Paessler, MD ATOS Clinic, Heidelberg
Principal Investigator: Holger Schmitt, MD Heidelberg University

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Responsible Party: Rebecca Horan, Serica Technologies, Inc. Identifier: NCT00490594     History of Changes
Other Study ID Numbers: CLN-ACL1
First Posted: June 22, 2007    Key Record Dates
Last Update Posted: October 20, 2008
Last Verified: October 2008

Keywords provided by Serica Technologies, Inc.:
ACL injury

Additional relevant MeSH terms:
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Knee Injuries
Leg Injuries
Wounds and Injuries