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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by Serica Technologies, Inc..
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00490594
First Posted: June 22, 2007
Last Update Posted: October 20, 2008
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.
Information provided by:
Serica Technologies, Inc.
  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 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • Knee Surveys [ Time Frame: 12 months ]
  • Return to Work [ Time Frame: 12 months ]

Estimated Enrollment: 30
Study Start Date: June 2007
Estimated Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: ACL Reconstruction (SeriACL™ Device)
    Bioresorbable ACL
  Eligibility

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.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

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

Keywords provided by Serica Technologies, Inc.:
ACL
ligament
ACL injury

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