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SeriACL™ Device (Gen IB) Trial for Anterior Cruciate Ligament (ACL) Repair

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00775892
First Posted: October 20, 2008
Last Update Posted: August 9, 2011
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
A multi-center single-arm clinical trial is being conducted to evaluate SeriACL device safety and performance during total anterior cruciate ligament (ACL) reconstruction.

Condition Intervention Phase
Anterior Cruciate Ligament Reconstruction Device: SeriACL Device ACL Reconstruction Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center Open Label Study to Evaluate the SeriACL™ Device (Gen IB) for Primary Anterior Cruciate Ligament Repair

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety - Adverse Events [ Time Frame: 12 months ]
  • KT-1000 Arthrometer Knee Laxity [ Time Frame: 12 months ]

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

Estimated Enrollment: 30
Study Start Date: September 2008
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: SeriACL Device ACL Reconstruction
    Long-term Bioresorbable ACL Scaffold
  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 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Major Inclusion Criteria:

  • Complete rupture of the ACL
  • Passive flexion >= 120° and passive extension = contralateral knee
  • MCL grade 2 or less
  • Pre-injury Tegner score >= 4
  • Informed Consent

Major Exclusion Criteria:

  • Prior ACL reconstruction.
  • Severe pain, swelling, or redness
  • Complete PCL tear
  • Complex menisci tears
  • Contralateral knee ligament injury
  • OA > Grade II
  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): NCT00775892


Locations
Austria
Dr. Pierer Sanatorium
Salzburg, Austria
Belgium
UZ Leuven
Leuven, Belgium
Germany
Dietrich-Bonhöffer-Klinik
Altentreptow, Germany
Medizinische Hochschule Hannover
Hannover, Germany
ATOS Clinic
Heidelberg, Germany
University of Heidelberg
Heidelberg, Germany
Sponsors and Collaborators
Serica Technologies, Inc.
Investigators
Principal Investigator: Hans Paessler, MD ATOS Clinic, Heidelberg
Principal Investigator: Johan Bellemans, MD UZ Leuven, Belgium
Principal Investigator: Holger Schmitt, MD Heidelberg University
Principal Investigator: Gerhard Oberthaler, MD Dr. Pierer Sanatorium, Salzburg, Austria
Principal Investigator: Uwe Pietzner, MD Dietrich-Bonhöffer-Klinik, Altentreptow, Germany
Principal Investigator: Michael Jagodzsinki, MD Hannover Medical School
  More Information

Responsible Party: Rebecca L Horan, PhD, Serica Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00775892     History of Changes
Other Study ID Numbers: CLN-ACL1B
First Submitted: October 16, 2008
First Posted: October 20, 2008
Last Update Posted: August 9, 2011
Last Verified: August 2011

Keywords provided by Serica Technologies, Inc.:
ACL
Ligament